Med Monthly August 2017

PHYSICIAN SOLUTIONS PRESENTS

Med Monthly MAGAZINE

August 2017

Overcoming Barriers to Successful Clinical Trials pg. 34

CLINICAL RESEARCH VERSUS MEDICAL TREATMENT pg. 26

the

Clinical Trials for a New Drug Discovery pg. 30

Clinical Your Trials & Practice issue

contents

16

features

26 CLINICAL RESEARCH VERSUS MEDICAL TREATMENT

8 TIPS TO BOOST YOUR MEDICAL PRACTICE REVENUE

30 CLINICAL TRIALS FOR A NEW DRUG DISCOVERY 34 OVERCOMING BARRIERS TO SUCCESSFUL CLINICAL TRIALS

practice tips

34

OVERCOMING BARRIERS TO SUCCESSFUL CLINICAL TRIALS

6

HEALTH CARE REFORM LEGISLATION COMPARISON

10 MEDICAL MARKETING: Should I outsource it and to whom?

14 BECOMING A SUCCESSFUL PRACTICE MANAGER 16 8 TIPS TO BOOST YOUR MEDICAL PRACTICE REVENUE

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THINKING ABOUT SELLING YOUR PRACTICE?

Medical Practice Listings can help you sell your practice online!

Now offering two types of listings to better serve all practice specialties and budgets.

For Sale by Owner Listing The For Sale by Owner Listing offers you the opportunity to gain national exposure by posting your listing on our website which is viewed daily by a network of qualified professionals. This option includes a brief practice consultation to explain the benefits of marketing through the Medical Practice Listings website. Our special rate for the For Sale by Owner listing through the end of 2017 is only $29.95 per month.

Professional Listing In addition to the benefits in the standard listing our Professional Listing affords you access to services provided by our expert legal and marketing team and a Bizscore Practice Valuation. This valuation compares your practice with other practices in your area, provides projections and determines what your practice is worth.

Visit us today at www.medicalpracticelistings.com to learn more.

919.848.4202 | medicalpracticelistings.com

is now hiring MD’s, PA’s, NP’s and DDS’s, in North Carolina, Florida, Georgia, Kentucky, South Carolina, Tennessee and Virginia

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phone: 919.845.0054 fax: 919.845.1947 e-mail: physiciansolutions@gmail.com www.physiciansolutions.com

Med Monthly August 2017 Publisher Creative Director Contributors

Philip Driver Thomas Hibbard Naren Arulrajah Vishal Gandhi, BSEE, MBA Barbara Hales, M.D. Nick Hernandez, MBS, FACHE Thomas Hibbard Damian A. Myers

contributors Naren Arulrajah is President and CEO of Ekwa Marketing, a complete Internet marketing company which focuses on SEO, social media, marketing education and the online reputations of Dentists and Physicians. If you have questions about marketing your practice online, call Naren direct at 877-249-9666.

Vishal Gandhi, BSEE, MBA is the founder and CEO ClinicSpectrum Inc. He is a well-known and widely respected authority on the “nitty-gritty� of medical practice workflow and technology. His Hybrid Workflow Model is quickly becoming a new healthcare industry standard model for combining human and computer workflow, to maximize revenue and minimize cost and he has appeared in prominent health IT publications.

Barbara Hales, M.D.

Med Monthly is a national monthly magazine committed to providing insights about the health care profession focusing on practical advice for physicians and practices. We are currently accepting articles to be considered for publication. For more information on writing for Med Monthly, please email us at medmedia9@gmail.com.

P.O. Box 99488 Raleigh, NC 27624 medmedia9@gmail.com

is a skilled expert in promoting your health services. As seen on NBC, CBS,ABC and FOX network affiliates as well as Newsweek, Dr. Hales writes all the content you need to promote your medical services.

Her latest book is on the best seller list and she can do the same for you. Check out her site at www.TheMedicalStrategist.com.

For a free marketing assessment, call 561-325-9664.

Nick Hernandez, MBA, FACHE is the CEO and founder of ABISA, a consultancy specializing in solo and small group practice management. He has consulted with clients in multiple countries and has over 20 years of leadership and operations experience. Visit www.abisallc.com for more information.

Online 24/7 at medmonthly.com

MED MONTHLY MAGAZINE |5

practice tips

Health Care Reform Legislation Comparison

By Damian A Myers Proskauer Rose LLP

Originally published by Proskauer.

Reprinted with permission.

6

| AUGUST 2017

The following chart compares key provisions of the Affordable Care Act (ACA), the American Health Care Act (AHCA) and the Better Care Reconciliation Act (BCRA). This chart is current as of July 13, 2017, and as of that date, neither the AHCA nor the BCRA have been enacted.

This is a partial representation of the chart. To view the chart in it entirety, go to http://www. erisapracticecenter.com/2017/07/updated-health-care-reform-legislation-comparisonchart/

Health Care Reform Legislation Comparison Shared Responsibility

ACA

AHCA

BCRA

Employer Mandate

Applicable large employers (those with 50 or more full-time employees and equivalents) face penalties if minimum essential coverage not offered to 95% of full-time employees (and dependents) or if coverage is not minimum value or affordable.

Individuals subject to tax if not enrolled in minimum essential coverage unless exception applies.

No penalties for failing to provide adequate coverage.

No penalties for failing to provide adequate coverage.

No tax for failing to enroll in minimum essential coverage.

However, effective for plan years beginning in 2019, a 30% premium surcharge would be charged by insurance carriers to an individual who purchases insurance coverage following a lapse in coverage of 63 days or more.

No change to ACA reporting requirements under IRC §§ 6055 and 6056. Additional Form W-2 reporting required.

No tax for failing to enroll in minimum essential coverage. However, individuals who have a lapse in coverage of 63 or more days in the prior 12-month period will be subject to a 6-month coverage waiting period.

Individual Mandate

Reporting

IRC §§ 6055 and 6056 require reporting from issuers of minimum essential coverage and applicable large employers.

No change to ACA reporting requirements under IRC §§ 6055 and 6056.

continued on page 8

MED MONTHLY MAGAZINE

| 7

continued from page 7

Market Reforms

ACA

AHCA

BCRA

Dependent Coverage

If dependent children covered, coverage must continue until age 26.

Small group and individual market plans must cover 10 essential health benefit categories, as defined by benchmark plan established by state.

No annual or lifetime dollar limits can be applied to essential health benefits.

No change.

No change.

No change, but states can apply for waiver to establish separate definition of essential health benefit.

No change, subject to relaxed waiver rights under ACA ยง 1332 (State Innovation Waivers).

No change, but states can apply for waiver to establish separate definition of essential health benefit.

No change, subject to relaxed waiver rights under ACA ยง 1332 (State Innovation Waivers).

Out-of-Pocket Maximums

Out-of-pocket maximum applied to essential health benefits.

Preexisting Condition Exclusions

Preexisting condition exclusions prohibited.

No change, subject to relaxed waiver rights under ACA ยง 1332 (State Innovation Waivers).

No change, but 6-month waiting period applied if individual has a gap in coverage of 63 days or more.

Preventive Care

No change, but states can apply for waiver to establish separate definition of essential health benefit.

No change, but insurance providers must apply a 30% premium surcharge if individual has a gap in coverage of 63 days or more.

No change.

Preventive care covered without cost-sharing Emergency room visit No change. at an out-of-network hospital must be covered at in-network rate.

Coverage cannot be No change. retroactively terminated except in cases of fraud or misrepresentation or for premium nonpayment.

Short (8-page) No change. disclosure of plan terms and glossary distributed on an annual basis.

Essential Health Benefits

Annual/Lifetime Dollar Limits

Emergency Coverage

Rescissions

Summaries of Benefits and Coverage

8

| AUGUST 2017

No change.

No change.

No change.

No change.

Market Reforms

ACA

AHCA

BCRA

Enhanced Claims Procedures

Claims procedures now require additional claims procedures and voluntary external review.

Cannot discriminate against a health care provider acting pursuant to state license.

Fully-insured employersponsored health plans cannot discriminate in favor of highly compensated individuals (not yet effective).

Individual and small group plans must spend 80% of premium income on claims and quality improvement.

Large group insurance plans must spend 85% of premium income on claims and quality improvement.

No change.

No change.

No change.

No change.

No change.

No change.

No change.

Applicable ratio determined by the state (effective for plan years beginning on or after January 1, 2019).

Provider Nondiscrimination Section 105(h) Nondiscrimination

Medical Loss Ratio

For the complete chart, including information on Tax Reform and Marketplace, please visit http://www.erisapracticecenter.com/2017/07/updated-health-care-reform-legislation-comparison-chart/

CALLING ALL WRITERS

Are you educated in the medical and health care field and looking to showcase your exceptional writing skills?

To become a contributing writer Contact us: in Med Monthly magazine, contact us at: medmedia9@gmail.com

Editorial Calendar: September - The New “Medical Billing”

919-845-0054 medmedia9@gmail.com physiciansolutions.com



October - Practices Going Paperless

MED MONTHLY MAGAZINE

| 9

practice tips

Medical Marketing:

Should I outsource it and to whom?

By Barbara Hales, M.D. www.TheMedicalStrategist.com

10

| AUGUST 2017

Two common questions asked in every hospital and medical practices now are “Should I outsource my health marketing and how do I find the outsourcing company that suits my practice best?”

By this time, most healthcare facilities and doctor’s offices recognize that aspects of marketing play a key role in helping to grow the practice and stand out among the competition.

Many physicians have tried to keep up with marketing, whether it is through social media, blogs, or newsletters only to find that it takes up too much time with the normal medical responsibilities and family life. They recognize that they’re unfamiliar with the marketing technology and like the practice of medicine, marketers need training and experience.

Employees or staff members have tried to fill the gap but this takes time away from their office duties (and they may be starting to complain about burning out or being overworked).

Yet, for damage control, you want to be on top of social comments and respond to them in a timely fashion. For prospective patients reaching out, you need to reply within a short time.

Patients want to engage with you and do not want to be ignored.

You may want to consider keeping certain aspects of your marketing while outsourcing others. Especially when it seems that every day a new marketing technique or social media channel is springing up, it is hard to learn about them.

7 Questions to Ask in Deciding Who to Hire for Outsourcing When vetting companies that perform outsourcing services, consider the responses to these key questions.

1. How do they look?

• • • • • • • • •

Check out the company website. Look at the following traits: Do you find the website design and graphics pleasing?

Is the site functional?

Is it easy to navigate?

Is it user friendly?

Is the content of high quality and without grammar or spelling errors?

Does it have a call-to-action?

Is it compatible with mobile devices?

Are the videos professional or amateur in appearance?

Do the links work?

2. What do their clients say?

Of course having testimonials speaks well for the company. You want to hear how detailoriented, easy to work with and outstanding the business is by an independent outside source rather than hear them tout it themselves. Take it a step further. Ask the company to supply a current and former client list of people that you can talk with. The outsourcer should not be adverse to this request.

3. Is the company forthright and transparent about subcontracting?

Many companies subcontract out parts of projects instead of relying solely on in-house staff. This ensures that the work meets the deadline in time crunches and that tasks requiring specific skills are done effectively. continued on page 12

MED MONTHLY MAGAZINE

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continued from page 11

The thing is, it is important to know how much of your project is being subcontracted out and which parts a third party is doing. If an unknown source is performing all your work, it is bound to cost more and may be inconsistent, often not being written in your voice or tone.

If the company is resistant to providing this information, it is best to avoid hiring them in the first place.

4. Is the company up-to-date on all the latest marketing trends?

Does the company you are analyzing offer newer marketing options like podcasts, Instagram, infographics and the latest social media channels that your patients may be on or are they offering only old techniques?

5. Does the company show how effective their marketing is?

Of course, since you are investing in marketing, you want to know whether there is a significant ROI (return on investment). Are the marketing techniques working and which ones work more effectively?

to acquire you as a client. Do they know your: • • • • • • • • •

Mission statement?

Current content?

Type of people you care for?

Age of patients you attend?

Products you offer?

Services you provide?

Any hospital affiliations?

Any published press releases?

Staff and each one’s role?

Any company looking to be hired by you should be diligent in researching your practice. They should be well acquainted with both you and your brand.

Making a proper assessment on any companies you are considering as a marketing associate means the difference between successful outsourcing and making a costly mistake.

If you are still in a quandary as to what will serve you best, reach out for a free consultation and we can discuss your needs at: Barbara@TheMedicalStrategist. com 

The Write Treatment

There are analytical tools that demonstrate the effectiveness of your marketing and the company should be able to show them to you.

6. Is the company accustomed to working with the health niche and your type of practice?

Marketing for business-to business brands is different than business-to-consumer brands and health professionals-to-patients is different again when it comes to the tone and what works best. Is the company experienced at working with physicians and medical practices? You don’t want someone who doesn’t understand the nomenclature and typical practices within the community.

7. How acquainted is the company with your practice?

Assess how well the company knows about your practice when agents promote their services, looking

12

| AUGUST 2017

Ezines and NewslettersCost Effective Powerful Tools • Drive traffic to your business website • Build relationships between yourself and patients • Get new patients • Announce a new service or product • Give great impact Have you got a newsletter yet or want to spread a message?

Contact Barbara Hales, M.D. for a free consultation.

Barbara@TheWriteTreatment.com 516-647-3002

practice tips

Becoming a Successful Practice Manager

By Nick Hernandez, MBA, FACHE CEO and Founder of ABISA

14

| AUGUST 2017

T

he charismatic practice manager starts out by knowing their job and the staff assigned to them and by planning, setting priorities, and meeting deadlines. But they also are able to communicate what their goals are for the practice and take the time to explain why certain tasks are required, where the practice is headed, and how it is going to get there. Accomplishing the mission within the capabilities of the practice and the resources allowed, while maintaining high morale, is the goal of every practice manager. An astute practice manager can become a high achiever by applying basic management and leadership principles to the practice of which they are a part. The manager begins this process by becoming as professional in their duties as they can. Here are five aspects of this process: 1. Knowing the Job The basis of successful leadership is making things happen through people, but first a practice manager must know her job.

The team they are working with will give them some slack when they are new to the practice, but that slack is rapidly used up if they do not seek to learn all they can about the practice operations. In the long run, staff will care only whether they know what they are doing, especially in difficult tasks.

2. Planning Accomplishing the mission requires planning and monitoring. Planning is the development of action steps needed to achieve an objective or goal. The ability to plan is closely related to the other skills required of practice managers, such as anticipating requirements, establishing priorities, and meeting deadlines. The plan should be flexible enough to handle the changes that inevitably will occur.

3. Implementation Once the plan is set, the practice manager has to consider priorities and prepare to meet deadlines, because they will never have

the luxury of working on only one task at a time. A physician practice is much too dynamic an organization to permit single task operations, and the practice manager has to learn how to keep several balls in the air simultaneously. It is a skill that starts with a plan, just like organizing homework and professional responsibilities at school.

Last-minute preparations rarely camouflage the lack of a routine approach to tasks. A methodical daily effort will produce wellqualified and motivated team members as well as an efficient practice. Crisis management and its negative impact on morale must be averted wherever possible.

4. Monitoring Progress A good plan must continually be monitored. There is a military adage that “you get what you inspect, not what you expect.� Practice managers should never just assume that a plan is working. Rather, managers must monitor effectiveness by following up on it by becoming personally involved.

5. Motivation Mission accomplishment and high morale occur in tandem. In other words, good practice managers get the job done and maintain high morale. The ability to get others to respond is a primary leadership requisite. The least a practice manger can learn to do is to delegate effectively. The ability to inspire others to perform is more difficult.

A practice manager must apply fundamental principles of administration and leadership as they learn how to accomplish tasks with their staff. Effective practice management is the ability to influence people so that they willingly and enthusiastically strive toward the achievement of practice goals. Hard work and high morale are compatible and good practice managers can inspire and direct their people under both normal and adverse conditions. 

MED MONTHLY MAGAZINE

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practice tips

8 Tips to Boost Your Medical Practice Revenue

By Vishal Gandhi, BSEE, MBA Founder and CEO

16

| AUGUST 2017

‘‘

“If you treat your staff like people and valuable resources to your office, you will see your personnel turnovers decrease and your profits increase.”

In today’s aggressive healthcare services industry, you find yourself managing pulverizing regulatory requirements and rising working costs.

You search for every skill set available to keep your practice profitable.

If you’re facing a ineffective appointment procedure, high staff turnover, or patients leaving due to long hold up times, these suggestions might be beneficial to you. The following eight tips can assist in your search for efficiency and profitability, utilizing only a small amount of time and cost expenditure. Please read and choose which strategies would work best for your practice.

1. Assemble an Online Presence A recent study demonstrates that 72% of patients consult the web for information on medical services and 62% utilize web surveys to discover new specialists, so your online presence is critical. Other than building a delightful practice site, a few of things you ought to do are submit your practice to online indexes, make your profile on the significant audit destinations, and get a web-based social networking profile up for your practice.

If you’re not on the web, new patients aren’t discovering you and your current patients know little about you.

2. Enhance Your Patient Collection Strategy Patient accumulation is an on-going pain for some specialists, particularly with the rising number of patients on high deductible insurances. Just 20% of practice income originates from patient co-pays, with most doctors gathering just 60% of what’s expected overall. It could be worthwhile to enlist an independent collections firm in the event that this is a concern at your practice.

3. Offer After-hours Virtual Visits We all realize that doing a twilight patient visit can increase income.

It just bodes well – you can fit more appointments into the day by going longer than your regular 9 to 5 hours and help your patients arrange visits around their busy schedules.

On the chance you decide to offer night-time visits from your office or provide reimbursable video visits, you can recover lost income in a very timely manner.

4. Respect Your Staff Your staff is your practice’s most important asset. Understand a content employee means a more satisfied patient. Give your staff positive criticism and support each day. Give them a voice in the practice’s day to day procedures, designate leaders for specific ventures, and perform one-onone gatherings to re-enforce a team spirit. If you treat your staff like people and valuable resources to your office, you will see your personnel turnovers decrease and your profits increase.

5. Utilize Your Mid-levels It doesn’t make any difference if you’re a small or large practice, you most likely have a few physician assistants or nurse practitioners on staff.

Ensure they’re working at their highest level of professionalism. Have them continued on page 18 MED MONTHLY MAGAZINE

| 17

continued from page 17

handle immediate patient demands and conditions, so patients can get in for same-day treatment when your calendar is full. The more they’re relieving demands on your time and directly interacting with patients, the more income you’ll be acquiring and the happier your patients and mid-levels will be.

6. Construct a Virtual Patient Procedure Optimizing an appointment timetable is one of those ventures that appear to be a miracle, combining both fine workmanship and science. A possible means of achieving this is rolling out a virtual visit procedure that will enable you to address appointment gridlock.

Virtual patient visits can be more adaptable to your schedule since patients can essentially sign in online from wherever they are. In the event that you have a last moment no-show or happen to have a 10-minute schedule vacancy in your day, you can get on the web and begin a virtual visit and lose no billable time.

7. Missed Appointment Options Missed appointments can cost your practice

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| AUGUST 2017

countless dollars every year. The fact of the matter is there’s just so much you can do when patients need to miss an visit because of work demands, baby sitter difficulties or traffic problems getting to your office.

Cancelation fees can assist to recover some of this cost; but offering patients virtual visits from their home for repeat missed appointment offenders can be truly beneficial for both parties.

8. Consider a Concierge Model For a few specialists, particularly those with a high Medicaid populace, a concierge model may not be the right answer. But for many doctors, transitioning to concierge medicine can be an extraordinary approach to increase income while dropping some of your regulatory weights. Changing over to a concierge practice is no little venture; however it can have tremendous benefits.

If you want to learn more about concierge medicine, check out https://www.forbes.com/sites/ johngoodman/2014/08/28/everyone-should-have-aconcierge-doctor/#61e9ee9f6323 

Practices for Sale Medical Practices Pediatric Practice Near Raleigh, NC

Location: Minutes South of Raleigh, North Carolina List Price: $145,000 Gross Yearly Income: $350,000 Year Established: 1980(s) Average Patients per Day: 16-22 Total Exam Rooms: 5 Building Owned/Leased: Owned. Will sell or lease.

Contact: Philip at 919-848-4202

Urology Practice near Lake Norman, NC Location: Minutes from Charlotte, NC List Price: $165,000 Gross Yearly Income: $275,000 Year Established: 1980 Average Patients per Day: 12 to 15 Building Owned/Leased: Leased Contact: Philip at 919-848-4202

Primary Care specializing in Women’s Practice

Family Practice/Primary Care

Location: Hickory, North Carolina List Price: $425,000 Gross Yearly Income: $1,5000,000 Year Established: 2007 Average Patients Per Day: 24-35 Total Exam Rooms: 5 Building Owned/Leased: Lease or Purchase Contact: Philip at 919-848-4202

Location: Morehead City, N.C. List Price: Just reduced to $20,000 or Best Offer Gross Yearly Income: $540,000 average for past 3 years Year Established: 2005 Average Patients per Day: 12 to 22 Building Owned/Leased: MD owned and can be leased or purchased Contact: Philip at 919-848-4202

Med Spa

Family Primary Care Practice

Practice Type: Mental Health, Neuropsychological and Psychological

Location: Minutes East of Raleigh, North Carolina List Price: $15,000 or Best Offer Gross Yearly Income: $235,000 Average Patients per Day: 8 to 12 Total Exam Rooms: 6 Physician retiring, Beautiful practice Building Owned/Leased: Owned (For Sale or Lease) Contact: Philip at 919-848-4202

Location: Coastal North Carolina List Price: $550,000 Gross Yearly Income: $1,600,000.00 Year Established: 2005 Average Patients Per Day: 25 to 30 Total Exam Rooms: 4 Building Owned/Leased: Leased Contact: Philip at 919-848-4202

Location: Wilmington, NC List Price: $110,000 Gross Yearly Income: $144,000 Year Established: 2000 Average Patients Per Day: 8 Building Owned/Leased/Price: Owned Contact: Philip at 919-848-4202

Special Listings Offer We are offering our “For Sale By Owner” package at a special rate. With a 6 month agreement, you receive 3 months free.

Considering your practice options? Call us today.

MED MONTHLY MAGAZINE

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What’s your practice worth?

When most doctors are asked what their practice is worth, the answer is usually, “I don’t know.”

Doctors can tell you what their practices made or lost last year, but few actually know what it’s worth.

In today’s world, expenses are rising and profits are being squeezed. A BizScore Performance Review will provide details regarding liquidity, profits & profit margins, sales, borrowing and assets.

Our three signature sections include:  Performance review  Valuation  Projections

Scan this QR code with your smart phone to learn more.

919.846.4747 bizscorevaluation.com

U.S. OPTICAL BOARDS Alaska P.O. Box 110806 Juneau, AK 99811 (907)465-5470 http://www.commerce.state.ak.us/dnn/ cbpl/ProfessionalLicensing/DispensingOpticians.aspx Arizona 1400 W. Washington, Rm. 230 Phoenix, AZ 85007 (602)542-3095 http://www.do.az.gov Arkansas P.O. Box 627 Helena, AR 72342 (870)572-2847 California 2005 Evergreen St., Ste. 1200 Sacramento, CA 95815 (916)263-2382 http://www.optometry.ca.gov/ Colorado 1560 Broadway St. #1310 Denver, CO 80202 (303)894-7750 http://www.dora.state.co.us/optometry/ Connecticut 410 Capitol Ave., MS #12APP P.O. Box 340308 Hartford, CT 06134 (860)509-7603 ext. 4 http://www.ct.gov/dph/cwp/view. asp?a=3121&q=427586 Florida 4052 Bald Cypress Way, Bin C08 Tallahassee, FL 32399 (850)245-4474 http://www.pof.org/opticianry-board/ Georgia 237 Coliseum Dr. Macon, GA 31217 (478)207-1671 http://sos.ga.gov/index.php/licensing/ plb/20 Hawaii P.O. Box 3469 Honolulu, HI 96801 (808)586-2704 http://hawaii.gov/dcca/pvl/programs/ dispensingoptician/

Idaho 450 W. State St., 10th Floor Boise , ID 83720 (208)334-5500 http://www.ironforidaho.net/

Oregon 3218 Pringle Rd. SE Ste. 270 Salem, OR 97302 (503)373-7721 http://www.oregonobo.org/optque.htm

Kentucky P.O. Box 1360 Frankfurt, KY 40602 (502)564-3296 http://www.opticiantraining.org/optician-training-kentucky/

Rhode Island 3 Capitol Hill, Rm 104 Providence, RI 02908 (401)222-7883 http://sos.ri.gov/govdirectory/index. php? page=DetailDeptAgency&eid=260

Massachusetts 239 Causeway St. Boston, MA 02114 (617)727-5339 http://1.usa.gov/zbJVt7

South Carolina P.O. Box 11329 Columbia, SC 29211 (803)896-4665 www.llr.state.sc.us

Nevada P.O. Box 70503 Reno, NV 89570 (775)853-1421 http://nvbdo.state.nv.us/

Tennessee Heritage Place Metro Center 227 French Landing, Ste. 300 Nashville, TN 37243 (615)253-6061 http://tn.gov/health

New Hampshire 129 Pleasant St. Concord, NH 03301 (603)271-5590 www.state.nh.us New Jersey P.O. Box 45011 Newark, NJ 07101 (973)504-6435 http://www.njsop.org/aws/NJSOP/pt/sp/ home_page New York 89 Washington Ave., 2nd Floor W. Albany, NY 12234 (518)402-5944 http://www.op.nysed.gov/prof/od/ North Carolina P.O. Box 25336 Raleigh, NC 27611 (919)733-9321 http://www.ncoptometry.org/ Ohio 77 S. High St. Columbus, OH 43266 (614)466-9707 http://optical.ohio.gov/

Texas P.O. Box 149347 Austin, TX 78714 (512)834-6661 http://www.tob.state.tx.us/ Vermont National Life Bldg N FL. 2 Montpelier, VT 05620 (802)828-2191 http://vtprofessionals.org/opr1/ opticians/ Virginia 3600 W. Broad St. Richmond, VA 23230 (804)367-8500 http://www.dpor.virginia.gov/Boards/ HAS-Opticians/ Washington 300 SE Quince P.O. Box 47870 Olympia, WA 98504 (360)236-4947 http://www.doh.wa.gov/LicensesPermitsandCertificates/MedicalCommission. aspx

MED MONTHLY MAGAZINE

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U.S. DENTAL BOARDS Alabama Alabama Board of Dental Examiners 5346 Stadium Trace Pkwy., Ste. 112 Hoover, AL 35244 (205) 985-7267 http://www.dentalboard.org/ Alaska P.O. Box 110806 Juneau, AK 99811-0806 (907)465-2542 https://www.commerce.alaska.gov/web/ cbpl/ProfessionalLicensing/BoardofDentalExaminers.aspx Arizona 4205 N. 7th Ave. Suite 300 Phoenix, AZ 85103 (602)242-1492 http://azdentalboard.us/ Arkansas 101 E. Capitol Ave., Suite 111 Little Rock, AR 72201 (501)682-2085 http://www.asbde.org/ California 2005 Evergreen Street, Suite 1550Â Sacramento, CA 95815 877-729-7789 http://www.dbc.ca.gov/

Hawaii DCCA-PVL Att: Dental P.O. Box 3469 Honolulu, HI 96801 (808)586-3000 http://cca.hawaii.gov/pvl/boards/dentist/ Idaho P.O. Box 83720 Boise, ID 83720 (208)334-2369 http://isbd.idaho.gov/ Illinois 320 W. Washington St. Springfield, IL 62786 (217)785-0820 http://www.isds.org/LawsLegislation/ boardOfDentistry.asp Indiana 402 W. Washington St., Room W072 Indianapolis, IN 46204 (317)232-2980 http://www.in.gov/pla/dental.htm

Colorado 1560 Broadway, Suite 1350 Denver, CO 80202 (303)894-7800 https://www.colorado.gov/pacific/dora/ Dental_Board

Iowa 400 SW 8th St. Suite D Des Moines, IA 50309 (515)281-5157 http://www.state.ia.us/dentalboard/

Connecticut 410 Capitol Ave. Hartford, CT 06134 (860)509-8000 http://www.ct.gov/dph/cwp/view. asp?a=3143&q=388884

Kansas 900 SW Jackson Room 564-S Topeka, KS 66612 (785)296-6400 http://www.dental.ks.gov/

Delaware Cannon Building, Suite 203 861 Solver Lake Blvd.

Dover, DE 19904 (302)744-4500 http://1.usa.gov/t0mbWZ

Kentucky 312 Whittington Parkway, Suite 101 Louisville, KY 40222 (502)429-7280 http://dentistry.ky.gov/

Florida 4052 Bald Cypress Way Bin C-08 Tallahassee, FL 32399 (850)245-4474 http://floridasdentistry.gov/ 22

Georgia 237 Coliseum Drive Macon, GA 31217 (478)207-2440 https://gbd.georgia.gov/

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Louisiana 365 Canal St., Suite 2680 New Orleans, LA 70130 (504)568-8574 http://dentistry.ky.gov/

Maine 143 State House Station 161 Capitol St. Augusta, ME 04333 (207)287-3333 http://www.mainedental.org/ Maryland 55 Wade Ave. Catonsville, Maryland 21228 (410)402-8500 http://dhmh.state.md.us/dental/ Massachusetts 1000 Washington St., Suite 710 Boston, MA 02118 (617)727-1944 http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/dhpl/ dentist/about/ Michigan P.O. Box 30664 Lansing, MI 48909 (517)241-2650 http://www.michigan.gov/lara/0,4601,7154-72600_72603_27529_27533---,00. html Minnesota 2829 University Ave., SE. Suite 450 Minneapolis, MN 55414 (612)617-2250 http://www.dentalboard.state.mn.us/ Mississippi 600 E. Amite St., Suite 100 Jackson, MS 39201 (601)944-9622 http://bit.ly/uuXKxl Missouri 3605 Missouri Blvd.

P.O. Box 1367 Jefferson City, MO 65102 (573)751-0040 http://pr.mo.gov/dental.asp Montana P.O. Box 200113 Helena, MT 59620 (406)444-2511 http://bsd.dli.mt.gov/license/bsd_ boards/den_board/board_page.asp

Nebraska 301 Centennial Mall South Lincoln, NE 68509 (402)471-3121 http://dhhs.ne.gov/publichealth/Pages/ crl_medical_dent_hygiene_board.aspx

Ohio Riffe Center 77 S. High St.,17th Floor Columbus, OH 43215 (614)466-2580 http://www.dental.ohio.gov/

Nevada 6010 S. Rainbow Blvd. Suite A-1 Las Vegas, NV 89118 (702)486-7044 http://www.nvdentalboard.nv.gov/

Oklahoma 201 N.E. 38th Terr., #2 Oklahoma City, OK 73105 (405)524-9037 http://www.ok.gov/dentistry/

New Hampshire 2 Industrial Park Dr. Concord, NH 03301 (603)271-4561 http://www.nh.gov/dental/

Oregon 1600 SW 4th Ave. Suite 770 Portland, OR 97201 (971)673-3200 http://www.oregon.gov/Dentistry/

New Jersey P.O Box 45005 Newark, NJ 07101 (973)504-6405 http://njpublicsafety.com/ca/dentistry/

Pennsylvania P.O. Box 2649 Harrisburg, PA 17105 (717)783-7162 http://www.dos.pa.gov/ProfessionalLicensing/BoardsCommissions/Dentistry/ Pages/default.aspx#.VbkfjPlPVYU

New Mexico Toney Anaya Building 2550 Cerrillos Rd. Santa Fe, NM 87505 (505)476-4680 http://www.rld.state.nm.us/boards/Dental_Health_Care.aspx New York 89 Washington Ave. Albany, NY 12234 (518)474-3817 http://www.op.nysed.gov/prof/dent/ North Carolina 507 Airport Blvd., Suite 105 Morrisville, NC 27560 (919)678-8223 http://www.ncdentalboard.org/ North Dakota P.O. Box 7246 Bismark, ND 58507 (701)258-8600 http://www.nddentalboard.org/

Rhode Island Dept. of Health Three Capitol Hill, Room 104 Providence, RI 02908 (401)222-2828 http://1.usa.gov/u66MaB South Carolina P.O. Box 11329 Columbia, SC 29211 (803)896-4599 http://www.llr.state.sc.us/POL/Dentistry/ South Dakota P.O. Box 1079 105. S. Euclid Ave. Suite C Pierre, SC 57501 (605)224-1282 https://www.sdboardofdentistry.com/ Tennessee 227 French Landing, Suite 300 Nashville, TN 37243 (615)532-3202 http://tn.gov/health

Texas 333 Guadeloupe St. Suite 3-800 Austin, TX 78701 (512)463-6400 http://www.tsbde.state.tx.us/ Utah 160 E. 300 South Salt Lake City, UT 84111 (801)530-6628 http://1.usa.gov/xMVXWm Vermont National Life Building North FL2 Montpelier, VT 05620 (802)828-1505 http://governor.vermont.gov/boards_ and_commissions/dental_examiners Virginia Perimeter Center 9960 Maryland Dr., Suite 300 Henrico, VA 23233 (804)367-4538 http://www.dhp.virginia.gov/dentistry Washington 310 Israel Rd. SE P.O. Box 47865 Olympia, WA 98504 (360)236-4700 http://www.doh.wa.gov/LicensesPermitsandCertificates/ProfessionsNewReneworUpdate/Dentist.aspx West Virginia 1319 Robert C. Byrd Dr. P.O. Box 1447 Crab Orchard, WV 25827 1-877-914-8266 http://www.wvdentalboard.org/ Wisconsin P.O. Box 8935 Madison, WI 53708 1(877)617-1565 http://dsps.wi.gov/Default. aspx?Page=90c5523f-bab0-4a45-ab943d9f699d4eb5 Wyoming 1800 Carey Ave., 4th Floor Cheyenne, WY 82002 (307)777-6529 http://plboards.state.wy.us/dental/index.asp

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U.S. MEDICAL BOARDS Alabama P.O. Box 946 Montgomery, AL 36101 (334)242-4116 http://www.albme.org/ Alaska 550 West 7th Ave., Suite 1500 Anchorage, AK 99501 (907)269-8163 http://www.medlicense.com/alaskamedical-license.html Arizona 9545 E. Doubletree Ranch Rd. Scottsdale, AZ 85258 (480)551-2700 http://www.azmd.gov Arkansas 1401 West Capitol Ave., Suite 340 Little Rock, AR 72201 (501)296-1802 http://www.armedicalboard.org/ California 2005 Evergreen St., Suite 1200 Sacramento, CA 95815 (916)263-2382 http://www.mbc.ca.gov/ Colorado 1560 Broadway, Suite 1350 Denver, CO 80202 (303)894-7690 http://www.docjungle.com/medicalboards/colorado-physician-licensing/ Connecticut 401 Capitol Ave. Hartford, CT 06134 (860)509-8000 http://www.ct.gov/dph/cwp/view. asp?a=3143&q=388902 Delaware Division of Professional Regulation Cannon Building 861 Silver Lake Blvd., Suite 203 Dover, DE 19904 (302)744-4500 http://dpr.delaware.gov/ District of Columbia 899 North Capitol St., NE Washington, DC 20002 (202)442-5955 http://doh.dc.gov/bomed 24

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Florida 2585 Merchants Row Blvd.

Tallahassee, FL 32399 (850)245-4444 http://www.stateofflorida.com/Portal/ DesktopDefault.aspx?tabid=115

Louisiana LSBME P.O. Box 30250 New Orleans, LA 70190 (504)568-6820 http://www.lsbme.la.gov/

Georgia 2 Peachtree Street NW, 36th Floor Atlanta, GA 30303 (404)656-3913 http://bit.ly/vPJQyG

Maine 161 Capitol Street 137 State House Station Augusta, ME 04333 (207)287-3601 http://www.maine.gov/md/

Hawaii DCCA-PVL P.O. Box 3469 Honolulu, HI 96801 (808)587-3295 http://hawaii.gov/dcca/pvl/boards/medical/

Maryland 4201 Patterson Ave. Baltimore, MD 21215 (410)764-4777 http://www.mbp.state.md.us/

Idaho Idaho Board of Medicine P.O. Box 83720 Boise, Idaho 83720 (208)327-7000 http://bit.ly/orPmFU

Massachusetts 200 Harvard Mill Sq., Suite 330 Wakefield, MA 01880 (781)876-8200 http://www.mass.gov/eohhs/gov/departments/borim/

Illinois 320 West Washington St. Springfield, IL 62786 (217)785 -0820 http://www.idfpr.com/

Michigan Bureau of Health Professions P.O. Box 30670 Lansing, MI 48909 (517)335-0918 http://michigan.gov/lara/0,4601,7-15472600_72603_27529_27541-58914--,00. html

Indiana 402 W. Washington St. #W072 Indianapolis, IN 46204 (317)233-0800 http://www.in.gov/pla/ Iowa 400 SW 8th St., Suite C Des Moines, IA 50309 (515)281-6641 http://medicalboard.iowa.gov/ Kansas 800 SW Jackson, Lower Level, Suite A Topeka, KS 66612 (785)296-7413 http://www.ksbha.org/ Kentucky 310 Whittington Pkwy., Suite 1B Louisville, KY 40222 (502)429-7150 http://kbml.ky.gov/Pages/index.aspx

Minnesota University Park Plaza 2829 University Ave. SE, Suite 500 Minneapolis, MN 55414 (612)617-2130 http://bit.ly/pAFXGq Mississippi 1867 Crane Ridge Drive, Suite 200-B Jackson, MS 39216 (601)987-3079 http://www.msbml.state.ms.us/ Missouri Missouri Division of Professional Registration 3605 Missouri Blvd.

P.O. Box 1335 Jefferson City, MO 65102 (573)751-0293 http://pr.mo.gov/healingarts.asp

Montana 301 S. Park Ave. #430 Helena, MT 59601 (406)841-2300 http://bsd.dli.mt.gov/license/bsd_ boards/med_board/board_page.asp Nebraska Nebraska Department of Health and Human Services P.O. Box 95026 Lincoln, NE 68509 (402)471-3121 https://www.nebraska.gov/LISSearch/ search.cgi Nevada Board of Medical Examiners P.O. Box 7238 Reno, NV 89510 (775)688-2559 http://www.medboard.nv.gov/ New Hampshire New Hampshire State Board of Medicine 2 Industrial Park Dr. #8 Concord, NH 03301 (603)271-1203 http://www.nh.gov/medicine/ New Jersey P. O. Box 360 Trenton, NJ 08625 (609)292-7837 http://www.medlicense.com/new-jerseymedical-license.html New Mexico 2055 S. Pacheco St. Building 400 Santa Fe, NM 87505 (505)476-7220 http://www.nmmb.state.nm.us/ New York Office of the Professions State Education Building, 2nd Floor Albany, NY 12234 (518)474-3817 http://www.op.nysed.gov/ North Carolina P.O. Box 20007 Raleigh, NC 27619 (919)326-1100 http://www.ncmedboard.org/

North Dakota 418 E. Broadway Ave., Suite 12 Bismarck, ND 58501 (701)328-6500 http://www.ndbomex.com/

Texas P.O. Box 2018 Austin, TX 78768 (512)305-7010 http://www.tmb.state.tx.us/

Ohio 30 E. Broad St., 3rd Floor Columbus, OH 43215 (614)466-3934 http://med.ohio.gov/

Utah P.O. Box 146741 Salt Lake City, UT 84114 (801)530-6628 http://www.dopl.utah.gov/licensing/physician_surgeon.html

Oklahoma P.O. Box 18256 Oklahoma City, OK 73154 (405)962-1400 http://www.okmedicalboard.org/ Oregon 1500 SW 1st Ave., Suite 620 Portland, OR 97201 (971)673-2700 http://www.oregon.gov/OMB/ Pennsylvania P.O. Box 2649 Harrisburg, PA 17105 (717)787-8503 http://www.dos.pa.gov/ProfessionalLicensing/BoardsCommissions/Medicine/ Pages/default.aspx#.Vbkgf_lPVYU Rhode Island 3 Capitol Hill Providence, RI 02908 (401)222-5960 http://1.usa.gov/xgocXV South Carolina P.O. Box 11289 Columbia, SC 29211 (803)896-4500 http://www.llr.state.sc.us/pol/medical/ South Dakota 101 N. Main Ave. Suite 301 Sioux Falls, SD 57104 (605)367-7781 http://www.sdbmoe.gov/ Tennessee 425 5th Ave. North Cordell Hull Bldg. 3rd Floor Nashville, TN 37243 (615)741-3111 http://tn.gov/health

Vermont P.O. Box 70 Burlington, VT 05402 (802)657-4220 http://1.usa.gov/wMdnxh Virginia Virginia Dept. of Health Professions Perimeter Center 9960 Maryland Dr., Suite 300 Henrico, VA 23233 (804)367-4400 http://1.usa.gov/xjfJXK Washington Public Health Systems Development Washington State Department of Health 101 Israel Rd. SE, MS 47890 Tumwater, WA 98501 (360)236-4085 http://www.medlicense.com/washingtonmedicallicense.html West Virginia 101 Dee Dr., Suite 103 Charleston, WV 25311 (304)558-2921 http://www.wvbom.wv.gov/ Wisconsin P.O. Box 8935 Madison, WI 53708 (877)617-1565 http://dsps.wi.gov/Boards-Councils/ Board-Pages/Medical-Examining-BoardMain-Page/ Wyoming 320 W. 25th St., Suite 200 Cheyenne, WY 82002 (307)778-7053 http://wyomedboard.state.wy.us/

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features

Clinical Research Versus Medical Treatment

What is clinical research?

Clinical research refers to studies in which people participate as patients or volunteers. Different terms are used to describe clinical research, including: • clinical studies • clinical trials • studies • research • trials • protocols.

Clinical research may have a number of goals, such as: • developing new treatments or medications • identifying causes of illness • studying trends • evaluating ways in which genetics may be related to an illness.

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The idea for a clinical research study—also known as a clinical trial—often originates in the laboratory.

After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases.

During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.

Strict rules for clinical studies have been put in place by National Institutes of Health and the FDA. Some studies involve promising new treatments that may directly benefit participants. Others do not directly benefit participants, but may help scientists learn better ways to help people.

Confidentiality is an important part of clinical research and ensures that personal information is seen only by those authorized to have access. It also means

Clinical Research Versus Medical Treatment Intent Intended Benefit Funding Timeframe Consent Assessment Protections

Certainty

Clinical Research

Medical Treatment

Answers specific questions through research involving numerous research volunteers.

Generally designed and intended to benefit future patients.

Paid for by drug developers and Government agencies.

Depends on research protocols.

Requires written informed consent.

Addresses the needs of individual patients.

Involves periodic and systematic assessment of patient data.

Protected by government agencies, institutional review boards, professional standards, informed consent, and legal standards.

Tests products and procedures of unproven benefit to the patient.

Access to Considered confidential intellectual Information property.

Release of Findings Published in medical journals, after clinical research ends.

that the personal identity and all medical information of clinical trial participants is known only to the individual patient and researchers. Results from a study will usually be presented only in terms of trends or overall findings and will not mention specific participants.

Clinical research is much different from the medical treatment you receive in a Healthcare Provider’s office.

Who should consider clinical trials and why?

Some people participate in clinical trials because none of the standard (approved) treatment options have worked, or they are unable to tolerate certain side effects. Clinical trials provide another option when standard therapy has failed. Others participate in trials because they want to contribute to the advancement of medical knowledge.

All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of

Intended to benefit the individual patient.

Funded by individual patients and their health plans.

Requires real-time decisions.

May or may not require informed consent.

Based on as-needed patient assessment.

Guided by state boards of medical practice, professional standards, peer review, informed consent, and legal standards.

Uses products and procedures accepted by the medical community as safe and effective.

Available to the general public through product labeling.

Individual medical records are not released to the general public.

disease, previous treatment history, and other medical conditions. This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study.

Therefore, not everyone who applies for a clinical trial will be accepted.

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people, because different people may respond differently to treatments. FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. Learn more about FDA’s efforts to increase diversity in clinical trials.

Where are clinical trials conducted?

Clinical trials can be sponsored by organizations (such as a pharmaceutical company), Federal offices and agencies (such as the National Institutes of continued on page 28

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Health or the U.S. Department of Veterans Affairs), or individuals (such as doctors or health care providers).

The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, hospitals, and other Federally or industry-funded research sites.

Are clinical trials safe?

FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial.

Before joining a particular study, you will be given an

informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.

What should I think about before joining a clinical trial?

Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment.

Be sure you understand: • • • •

what happens during the trial the type of health care you will receive any related costs once you are enrolled in the trial the benefits and risks associated with participating.

What is FDA’s role in approving new drugs and medical treatments?

FDA makes sure medical treatments are safe and effective for people to use. We do not develop new therapies or conduct clinical trials. Rather, we oversee the people who do. FDA staff meet with researchers and perform inspections of clinical trial study sites to protect the rights of patients and to verify the quality and integrity of the data.

Learn more about the Drug Development Process.

Where can I find clinical trials?

One good way to find out if there are any clinical trials that might help you is to ask your doctor. Other sources of information include: • FDA Clinical Trials Search. Search a database of Federally and privately supported studies available through clinicaltrials.gov. Learn about each trial’s purpose, who can participate, locations, and who to contact for more information.

• Clinicaltrials.gov. Conduct more advanced searches • National Cancer Institute or call 1–800–4–CANCER (1–800–422–6237).

Learn about clinical trials for people with cancer.

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• AIDSinfo. Search a database of HIV/AIDS trials, sponsored by the National Institutes of Health’s National Library of Medicine.

What is a placebo and how is it related to clinical trials?

A placebo is a pill, liquid, or powder that has no treatment value. It is often called a sugar pill. In clinical trials, experimental drugs are often compared with placebos to evaluate the treatment’s effectiveness.

Is there a chance I might get a placebo?

In clinical trials that include placebos, quite often neither patients nor their doctors know who is receiving the placebo and how is being treated with the experimental drug. Many cancer clinical trials, as well as trials for other serious and life-threatening conditions, do not include placebo control groups. In these cases, all participants receive the experimental drug. Ask the trial coordinator whether there is a chance you may get a placebo rather than the experimental drug. Then, talk with your doctor about what is best for you.

How do I find out what Phase a drug is in as part of the clinical trial?

Talk to the clinical trial coordinator to find out which phase the clinical trial is in. Learn more about the different clinical trial phases and whether they are right for you.

What happens to drugs that don’t make it out of clinical trials?

Most drugs that undergo preclinical (animal) research never even make it to human testing and review by the FDA. The drug developers go back to begin the development process using what they learned during with their preclinical research. Learn more about drug development.

Learn more about the basics of clinical trial participation, read first hand experiences from actual clinical trial volunteers, and see explanations from researchers at the NIH Clinical Research Trials and You Web site.  Source: https://www.fda.gov/ForPatients/ ClinicalTrials/ClinicalvsMedical/ucm20041761.htm

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features

Clinical Trials for a New Drug Discovery

By Thomas Hibbard Creative Director, Med Monthly

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Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

Every clinical trial has a protocol, or action plan, for conducting the trial.

The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can take part. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

An Institutional Review Board (IRB) reviews, monitors, and approves many clinical trials. It is an independent committee of physicians, statisticians, and members of the community. Its role is to • Make sure that the study is ethical • Protect the rights and welfare of the participants • Make sure that the risks are reasonable when compared to the potential benefits In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government.

Preclinical Testing New drugs begin in the laboratory with scientists, including chemists and pharmacologists, who identify cellular and genetic factors that play a role in specific diseases. They search for chemical and biological substances that target these biological markers and are likely to have drug-like effects.

Out of every 5,000 new compounds identified during the discovery process, only five are considered safe for testing in human volunteers after preclinical evaluations. After three to six years of further clinical testing in patients, only one of these compounds is ultimately approved as a marketed drug for treatment. The following sequence of research activities begins the process that results in development of new medicines: • Target Identification. Drugs usually act on either cellular or genetic chemicals in the body, known as targets, which are believed to be associated with disease. Scientists use a variety of techniques to identify and isolate individual targets to learn more about their functions and how they influence disease. Compounds are then identified that have various interactions with the drug targets that might be helpful in treatment of a specific disease.

• Target Prioritization/Validation. To select targets most likely to be useful in the development of new treatments for disease, researchers analyze and compare each drug target to others based on their association with a specific disease and their ability to regulate biological and chemical compounds in the body. Tests are conducted to confirm that interactions with the drug target are associated with a desired change in the behavior of diseased cells. Research scientists can then continued on page 32 MED MONTHLY MAGAZINE

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identify compounds that have an effect on the target selected.

• Lead Identification. A lead compound or substance is one that is believed to have potential to treat disease. Laboratory scientists can compare known substances with new compounds to determine their likelihood of success. Leads are sometimes developed as collections, or libraries, of individual molecules that possess properties needed in a new drug. Testing is then done on each of these molecules to confirm its effect on the drug target.

• Lead Optimization. Lead optimization compares the properties of various lead compounds and provides information to help biopharmaceutical companies select the compound or compounds with the greatest potential to be developed into safe and effective medicines.

Often during this same stage of development, lead prioritization studies are conducted in living organisms (in vivo) and in cells in the test tube (in vitro) to compare various lead compounds and how they are metabolized and affect the body.

Three Phases of Clinical Trial Most clinical research that involves the testing of a new treatment progresses in phases.

This allows researchers to ask and answer questions in a way that yields reliable information about the treatment and protects the patients.

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Clinical trials are usually classified into one of three phases: 1. Phase I Trials are the first step in testing a new treatment in humans. In these studies, researchers may evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen. About 70 percent of experimental drugs pass this initial phase of testing.

2. Phase II Trials focus on evaluating how well the new treatment works. They also continue to test the safety of the treatment. This second phase of testing may last from several months to two years, and involves up to several hundred patients. About one-third of experimental drugs successfully complete both phase I and phase II studies.

3. Phase III Trials compare the results of people taking the new treatment with results of people taking standard treatment.

Investigators usually assign participants to the standard treatment group or the new treatment group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors’ offices, clinics, and health centers nationwide.

The Length of Clinical Trials Clinical trials can take several years to complete. Some possible reasons are:

• For chronic conditions such as cancer, it takes months, if not years, to see if a cancer treatment has an effect on a patient.

• For drugs that are not expected to have a strong effect (meaning a large number of patients must be recruited to observe ‘any’ effect), recruiting enough patients to test the drug’s effectiveness (i.e., getting statistical power) can take several years.

• Only certain people who have the target disease condition are eligible to take part in each clinical trial. Researchers who treat these particular patients must participate in the trial.

Then they must identify the desirable patients and obtain consent from them or their families to take part in the trial.

The biggest barrier to completing studies is the shortage of people who take part. All drug and many device trials target a subset of the population, meaning not everyone can participate. Some drug trials require patients to have unusual combinations of disease characteristics. It is a challenge to find the appropriate patients and obtain their consent, especially when they may receive no direct benefit (because they are not paid, the study drug is not yet proven to work, or the patient may receive a placebo). In the case of cancer patients, fewer than 5% of adults with cancer will participate in drug trials.  Reference: https://medlineplus.gov/clinicaltrials. html

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features

Overcoming Barriers to Successful Clinical Trials

By Naren Arulrajah Ekwa Marketing

34 | AUGUST 2017

Conducting clinical research can be a rewarding aspect of your practice. It can keep you at the forefront of new developments in your field, boost your professional reputation, and increase your practice’s profits. However, clinical trials also present a number of challenges, which can result in wasted time and lost money. How can you avoid the pitfalls?

Profitability You may not think of research as a profit center. In fact, many researchers, especially in hospitals and large multi-physician practices, do not track whether or not research is generating income.

It is an academic endeavor, a service to your patients, and an activity for the greater good. These things are all true, but it is also a potential source of significant revenue with careful planning.

The first step is choosing the right trial. Consider the physical space, facilities, and special equipment that a trial requires. If your office does not meet these needs, your initial investment will be greater.

Before you commit to a trial, develop a realistic budget. Take into consideration future revenue that may be generated by office upgrades or equipment purchases.

Research coordinators and other specialized staff members may work on several trials. If so, divide their payroll between the projects.

Any one-time expenses specific to the trial should be calculated at full cost. Don’t forget the expenses of any compensation offered to participants.

If your estimated budget does continued on page 36

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not reflect profitability, then look for a different research project. Once you have committed to a project, stick to your budget.

Recruitment Approximately 11 percent of clinical trial sites fail to enroll any patients at all, and about half of all sites are plagued by under-enrollment. Often, doctors begin research without developing a recruitment strategy. They expect to have plenty of participants from their own patient base. However, enrolling current patients is not as easy as it sounds.

Most trials have very specific criteria for participation, so you could have a limited number of eligible patients. Furthermore, convincing those people to participate can be challenging. Some doctors and dentists are uncomfortable suggesting a trial, or they don’t know how to approach the patient. They are also unprepared when patients react with fear or suspicion at the thought of an experimental treatment.

A good recruitment strategy can help you enroll more patients and reach more potential participants outside of your practice.

• Estimate patient eligibility. When you choose a trial, review the requirements carefully and review your patient database. Do you have a large pool of potential study volunteers? This will tell you whether you need to focus more of your efforts on inhouse or offsite recruitment.

• Prepare yourself and your team. How will you explain the study? What questions are people likely to ask, and how will you answer? The most common concerns are fear of side effects, potential health risk, and the possibility of receiving a placebo. You should be ready to answer these and similar questions honestly and accurately, while also explaining why you believe the research is beneficial.

• Connect with other doctors or dentists. Referrals can be one of your best sources of participants.

To engage with fellow physicians, talk to them in person or communicate regularly by phone and email. You should be able to provide literature, and detailed information about the study, and be sure to follow up after the trial is complete. Insufficient information is one of the most common reasons 36

| AUGUST 2017

‘‘

“Clinical trial is an academic endeavor, a service to your patients, and an activity for the greater good, but it is also a potential source of significant revenue with careful planning”

that doctors choose not to recommend a study to their patients.

• Reach out. Use your regular marketing channels, including search marketing, email, and social media, to spread the word about your trial.

Retention You have started your trial and successfully recruited enough participants. Unfortunately, your enrollment problems are not over. The next challenge is retention. Participating in a trial takes time, and sometimes it costs money in the form of lost wages or transportation costs. Depending on the study, you may be asking people to alter their diets, activity levels, or habits. Sometimes treatments have unpleasant side effects, or patients become disillusioned when they fail to see improvement in their conditions.

When planning your research, think about what you are asking of participants. Will it be a financial burden? Will it interfere with their daily lives? What compensation are you offering? Are you assisting with transportation, special foods, and other requirements?

Your budget and plan should include provisions to relieve the burden of patient participation.

Perhaps the most important aspect of volunteer retention is the human factor. You have an advantage when working with people who were recruited from your patient database. You were their doctor or dentist before the study began, and they already know most members of your team. For new patients, it is especially important to establish trust, demonstrate your excellent customer service, and quickly form a good-doctor patient relationship.

Throughout the study, keep an open line of communication with your participants. Make yourself available, or have a dedicated clinical advisor who patients can easily contact. Rather than avoiding

difficult questions, address their concerns honestly.

Also, discuss the study with participants frequently, let them know what is going on and what to expect, and make sure they know that their participation is appreciated.

Clinical research is not a simple sideline for your dental or medical practice. It is a significant undertaking, which will consume a considerable amount of time and resources. However, success is not as elusive as it first seems, if you are willing to face the challenges and you are ready with a strategic plan.  About the Author: Naren Arulrajah is President and CEO of Ekwa Marketing, a complete internet marketing company that focuses on SEO, social media, marketing education, and the online reputations of dentists and physicians. With a team of 140+ full time marketers, www.ekwa.com helps doctors who know where they want to go, get there by dominating their market and growing their business significantly year after year. If you have questions about marketing your practice online, call 855-598-3320 to speak one-on-one with Naren.

MODERN

Urgent Care

Serving Raleigh, Cary, Apex, Holly Springs, Fuquay Varina, Brier Creek and South Point Mall areas.

This is certainly one of the most consistently utilized practices serving a large demographic area. 6 exam or procedure rooms, 1 X-Ray in a well appointed and nicely designed practice. Averaging 28 to 30 patients per day, year round and open 365 days per year. The staff includes two providers and full experienced staff to include X-Ray personal. The gross revenues of this practice exceeds one million two hundred thousand yearly. Priced at $260,000.

Call 919-848-4202 or e-mail medlistings@gmail.com www.medicalpracticelistings.com

MD STAFFING AGENCY FOR SALE IN NORTH CAROLINA The perfect opportunity for anyone who wants to purchase an established business.

Primary Care Practice For Sale in Wilmington, NC Established primary care on the coast of North Carolina’s beautiful beaches. Fully staffed with MD’s and PA’s to treat both appointment and walk-in patients. Excellent exam room layout, equipment and visibility.

Contact Medical Practice Listings for more information.

l One

of the oldest Locums companies client list l Dozens of MDs under contract l Executive office setting l Modern computers and equipment l Revenue over a million per year l Retiring owner l Large

Medical Practice Listings

Please direct all correspondence to driverphilip@gmail.com.

Only serious, qualified inquirers.

919.848.4202 | medlistings@gmail.com www.medicalpracticelistings.com

Internal Medicine Practice for Sale

Urology Practice minutes from Lake Norman, North Carolina

Located in the heart of the medical community in Cary, North Carolina, this Internal Medicine practice is accepting most private and government insurance payments.

The average patients per day is 20-25+, and the gross yearly income is $555,000.

Listing Price: $430,000

Call 919-848-4202 or e-mail medlistings@gmail.com www.medicalpracticelistings.com 38 | AUGUST 2017

Urology Practice minutes from Lake Norman is now listed for sale. This excellent located practice is convenient to Charlotte, Gastonia, Lincolnton and Hickory. With a solid patient base, procedures currently include; Adult & Pediatric Urology, Kidney Stones, Bladder Problems, Incontinence, Prostate Issues, Urinary Tract Infections, Wetting Problems, Erectile Dysfunction and related issues. Three exam rooms with two electronic tables and one flat exam table.

Established: 1980 l Gross Yearly Income: $275,000 Average Patients per Day: 12 to 15 l List Price: $165,000

Contact Philip or Danielle at 919-848-4202 or email medlistings@gmail.com

Pediatric Practice Available Near Raleigh, NC

State of Cha-Ching.

Pediatric practice located minutes south of Raleigh, North Carolina is now listed for sale. Located in an excellent area convenient to Raleigh, Cary, and Durham, it is surrounded by a strong health care community. This is a well established practice with a very solid patient base. The building is equipped with a private doctor’s office, five exam rooms, and an in-house lab.

Lindsay Gianni, Agent 12333 Strickland Road Suite 106 Raleigh, NC 27613 Bus: 919-329-2913 lindsay.gianni.f23o@statefarm.com

™

Established: 1980s l Gross Yearly Income: $350,000 Average Patients per Day: 16 to 22 l List Price: $145,000

Call 919-848-4202 or e-mail medlistings@gmail.com www.medicalpracticelistings.com

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*Discounts and their availability may vary by state and eligibility requirements.

For more information, please see or call a State Farm agent.

1101216.1 State Farm, Home Office, Bloomington, IL

PRIMARY CARE PRACTICE East of Raleigh, North Carolina We are offering a well established primary care practice only minutes east of Raleigh North Carolina. The retiring physician maintains a 5 day work week and has a solid base of patients that can easily be expanded. There are 6 fully equipped exam rooms, a large private doctor’s office, spacious business office, and patient friendly check in and out while the patient waiting room is generous overlooking manicured flowered grounds. This family practice is open Monday through Friday and treats 8 to a dozen patients per day.

Currently operating on paper charts, there is no EMR in place. The Gross revenue is about $235,000 yearly.

We are offering this practice for $50,000 which includes all the medical equipment and furniture. The building is free standing and can be leased or purchased.

Contact Philip at 919-848-4202 to receive details and reasonable offers will be presented to the selling physician.

MedicalPracticeListings.com | medlisting@gmail.com | 919-848-4202 MED MONTHLY MAGAZINE

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Eastern North Carolina Family Practice Available Well-appointed Eastern North Carolina Family Practice established in 2000 is for sale in Williamston, NC. This organized practice boasts a wide array of diagnostic equipment including a GE DEXA scanner with a new tube, GE case 8000 stress testing treadmill and controller and back up treadmill, Autoclave and full set of operating equipment, EKG-Ez EKG and much more. The average number of patients seen daily is between 12 to 22. The building is owned

by MD and can be purchased or leased.

The owning physician is relocating and will assist as needed during the transition period. The gross receipts for the past three years average $650,000 and the list price was just reduced to $185,000. If you are looking to purchase a well equipped primary care practice, please contact us today.

919-848-4202 medlisting@gmail.com medicalpracticelistings.com

PEDIATRICIAN

or family medicine doctor needed in

FAYETTEVILLE, NC

PSYCHIATRIST PRACTICE LOCATED IN JACKSONVILLE, FL Established with a solid patient base, this well appointed practice also has a Psychologist in house. The psychiatrist is willing to stay and practice for a month or so assuring a nice patient transition.

The city of Jacksonville is underserved by psychiatrist as most patients wait 4 to 5 months to secure an appointment. Treating over a dozen patients per day year round, you can step into this practice with the assurance knowing you will have a solid income and positioning for success. The established doctor is looking to retire but very willing to assure the buyer is comfortable moving forward. Asking $135,000 fully furnished.

Contact Philip or Danielle at 919-848-4202 or email medlistings@gmail.com 40

| AUGUST 2017

Comfortable seeing children. Needed immediately.

Call 919- 845-0054 or email: physiciansolutions@gmail.com www.physiciansolutions.com

NC MedSpa For Sale MedSpa Located in North Carolina We have recently listed a MedSpa in NC This established practice has staff MDs, PAs and nurses to assist patients. Some of the procedures performed include: Botox, Dysport, Restylane, Perian, Juvederm, Radiesse, IPL Photoreju Venation, fractional laser resurfacing as well as customized facials. There are too many procedures to mention in this very upscale practice. The qualified buyer will be impressed with the $900,000 gross revenue. This is a new listing, and we are in the valuation process.

Urgent Care serving the South Raleigh and Garner, NC area Established practice averaging 25 to 30 patients per day, year round. Open 7 days a week with two providers and established staff members. 4 exam rooms, 1 procedure room and 1 lab-phlebotomy room.

This is a very well laid out and attractive practice in a heavily traveled area with excellent parking. Gross revenues of about one million per year and positioned for continued growth. Priced at $200,000.

Contact Medical Practice Listings today to discuss the practice details.

For more information call Medical Practice Listings at 919-848-4202 or e-mail medlistings@gmail.com

www.medicalpracticelistings.com

Medical Practice Listings Call 919-848-4202 or e-mail medlistings@gmail.com www.medicalpracticelistings.com

Located on NC’s Beautiful Coast,

Morehead City

Primary Care Specializing in Women’s Health Practice established in 2005, averaging over $540,000 the past 3 years. Free standing practice building for sale or lease. This practice has 5 well equipped exam rooms and is offered for $20,000.

919.848.4202 medlisting@gmail.com medicalpracticelistings.com MED MONTHLY MAGAZINE

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Orthopedic Practice serving Eastern NC, minutes from the Atlantic Ocean

Practice for Sale in Raleigh, NC Primary care practice specializing in women’s care Raleigh, North Carolina

Orthopedic practice for sale on the coast of North Carolina, established with a solid patient base. The demographics for this practice are excellent and the location impressive. This newly listed practice is fully furnished, staffed and ready for a fresh face to see orthopedic patients in this beautiful part of North Carolina. The ingredients for success have been established and the owning doctor is willing to stay with you for a reasonable time to assure a smooth transfer of care. This is the perfect practice to add on to your existing practice as a satellite or to make it your main orthopedic practice. Includes X-Ray and could be easily converted to an urgent care.

Average Orthopedic Patients per Day: 10 to 15

l

The owning physician is willing to continue with the practice for a reasonable time to assist with smooth ownership transfer. The patient load is 35 to 40 patients per day, however, that could double with a second provider. Exceptional cash flow and profit will surprise even the most optimistic practice seeker. This is a remarkable opportunity to purchase a well-established woman’s practice. Spacious practice with several well-appointed exam rooms and beautifully decorated throughout. New computers and medical management software add to this modern front desk environment.

List price: $435,000

List Price: Under Valuation

Call Medical Practice Listings at (919) 848-4202 for details and to view our other listings visit www.medicalpracticelistings.com

Contact Philip or Danielle at 919-848-4202 or email medlistings@gmail.com

PRIMARY CARE PRACTICE - Hickory, North Carolina This is an outstanding opportunity to acquire one of the most organized and profitable primary care practices in the area. Grossing a million and a half yearly, the principal physician enjoys ordinary practice income of over $300,000 annually.

Hickory is located in the foot-hills of North Carolina and is surrounded by picturesque mountains, lakes, upscale shopping malls and the school systems are excellent. If you are looking for an established practice that runs like a well oiled machine, request more information.

The free standing building that houses this practice is available to purchase or rent with an option. There are 4 exam rooms with a well appointed procedure room. The owning physician works 4 to 5 days per week and there is a full time physician assistant staffed as well.

For the well qualified purchasing physician, the owner may consider some owner-financing. Call us today.

List price: $425,000 | Year Established: 2007 | Gross Yearly Income: $1,500,000

MedicalPracticeListings.com | medlisting@gmail.com | 919-848-4202 42

| AUGUST 2017

Modern Med Spa Available

Located in beautiful coastal North Carolina Modern, well-appointed med spa is available in the eastern part of the state. This Spa specializes in BOTOX, facial therapy and treatments, laser hair removal, eye lash extensions and body waxing as well as a menu of anti-aging options. This impressive practice is perfect as-is and can accommodate additional services like primary health or dermatology.

The Gross revenue is over $1,500.000 with consistent high revenue numbers for the past several years. The average number of patients seen daily is between 26 and 32 with room for improvement. You will find this Med Spa to be in a highly visible location with upscale amenities. The building is leased and the lease can be assigned or restructured. Highly profitable and organized, this spa is POISED FOR SUCCESS. 919.848.4202 medlisting@gmail.com medicalpracticelistings.com

We have several qualified MDs seeking established Urgent Care Practices in North Carolina.

Urgent Care Practices Wanted If you have an urgent care practice and would like to explore your selling options, please contact us. Your call will be handled confidentially and we always put together win-win solutions for the seller and buyer.

Call Medical Practice Listings today and ask for Philip Driver 919-848-4202.

Pediatrics Practice Wanted Pediatrics Practice Wanted in NC Considering your options regarding your pediatric practice? We can help. Medical Practice Listings has a well qualified buyer for a pediatric practice anywhere in central North Carolina.

Contact us today to discuss your options confidentially.

Medical Practice Listings Call 919-848-4202 or e-mail medlistings@gmail.com www.medicalpracticelistings.com MED MONTHLY MAGAZINE

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Physician Solutions, Inc. Medical & Dental Staffing

The fastest way to be $200K in debt is to open your own practice The fastest way to make $100K is to choose

Physician Solutions

THE DECISION IS YOURS Physician Solutions, Inc. P.O. Box 98313 Raleigh, NC 27624 Scan this QR code with your smartphone to learn more.

phone: 919-845-0054 fax: 919-845-1947 www.physiciansolutions.com physiciansolutions@gmail.com