The Indiana Chapter July 2010 Newsletter A Day at the Zoo 2010 Indiana-Ohio Valley Chapter Conference On April 10th, a warm spring day with birds chirping and flowers blooming, the 2010 Indiana-Ohio Valley Chapter Conference took place at the Indianapolis Zoo. Approximately 50 people registered for the conference, a record high in the Indiana chapterâ€&#x;s history. This joint conference offered 4 AMWA Credit Workshops led by Susan Aiello and Art Gertel, as well as 4 Career Enrichment Open Sessions, which were new to the chapter conference and were offered free to conference registrants. Besides these educational events, the participants also enjoyed networking with fellow medical writers and editors, visiting sponsorsâ€&#x; exhibition desks, and interacting with animals at the Zoo during the lunch break. In this newsletter, you will find an interview with Anne Marie Wolka, PhD, one of the meeting organizers, who shared her story of volunteering for the chapter conference. You can also read the summaries of the four Career Enrichment Open Sessions if you were not able to attend them at the conference. These summaries were written by our volunteers Margaret Perry, MA, CGC, Kristin Bullok, PhD, Julie Beyrer, MTSC and Connie Ross, BS, and were edited by Noreen Pierle. I hope you enjoy this issue of the newsletter! Qing Zhou, PhD Newsletter Editor, AMWA Indiana Chapter
AMWA Indiana Chapter Newsletter July, 2010
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The Indiana Chapter The Making of the Chapter Conference -An interview with Anne Marie Wolka, PhD Qing Zhou, PhD 1. The Indianapolis Zoo is a much unexpected (and surprisingly delightful) venue for the chapter conference. How did you find out about it? What was the feedback from participants about the venue? The Indiana and Ohio Valley chapters co-hosted the conference this year, and the organizers were looking for an interesting venue in the Indianapolis area, one that might be a bit more special than an office building or hotel. The Indianapolis Zoo made our short list of venues to research, and we found that Zoo personnel were very responsive and supportive in working with us to plan a spectacular conference. The organizers also hoped that the Zoo would attract people not only from Indianapolis, but also people considering coming from out of state. In fact, we found that people from 8 different states attended the conference! Many people gave feedback that the Zoo was part of what had attracted them to attend the conference; for those who said they would have come anyway, they said that the beautiful Zoo venue was just a bonus. Many people also enjoyed the special lunch-time Animal Encounter that the Zoo offered to participants. The Animal Encounter was perhaps a once-in-a-lifetime opportunity for people to pet a hedgehog, parrot, and snake, among other critters! 2. This is the first time that our chapter conference offered Career Enrichment Open Sessions. How did the planning committee come up the idea of offering open sessions? How were the topics chosen? How were the open sessions received by the participants? The Indiana and Ohio Valley Chapters have a lot of members who already hold AMWA certificates, and had received feedback in the past that some members would be interested in offerings outside the usual credit workshops. This led to the concept of the career enhancement open sessions, which were designed for those who wanted to come to the conference to learn, but who didn't necessarily want or need AMWA credits. The organizing committee discussed a number of topics that we thought would make for good open sessions, and then voted on which ideas were our favorites. We tried to offer open sessions that would appeal to different groups of medical writers, depending on their specialty (e.g. regulatory, publications, career ideas, etc.) We decided to try offering the open sessions for free (with conference registration), to try to attract as many registrants as possible. Participants seemed to enjoy the open sessions, and many gave feedback that the open sessions were AMWA Indiana Chapter Newsletter July, 2010
what had drawn them to attend the conference. We hope to offer these again in the future! 3. What were the most challenging steps/tasks for you or the committee in the planning process? How did you address them? What lessons did you learn? I think what was most challenging was thinking of all the details that needed to be taken care of, and then attending to them (or delegating them), from paying for the venue and caterer, to deciding on what food would be served at lunch, to designing the registration brochure, to sending communications to advertise the conference, to deciding what presenters would be located in which rooms at the Zoo, to ensuring that everyone paid for their registration and workshops, to deciding on the workshops to be offered and making arrangements with all the presenters, and on and on, ad infinitum! Having the conference at the Zoo, as opposed to an office building, also added a level of complexity, because we had to work out additional details related to ordering Zoo tickets, putting up signs so people could navigate around the Zoo, etc. The good news is, we now know what all goes into holding a conference at the Zoo, so the planning process would be much easier if we decide to have future conferences there. One of the lessons I learned was to never hesitate to ask questions. The Zoo personnel probably answered hundreds (or thousands?!) of our questions during the planning process, and they definitely made everything easier! 4. I know that you worked very hard and spent a lot of time in planning for the chapter conference. What experience/skills did you gain from working on the planning committee? I think leadership was the skill that I am most glad to have gained from heading up the conference planning committee. There were many times when a decision needed to be made, and I realized that sometimes I just needed to make a decision! There were other times when people who were helping to plan the conference asked me questions, and I needed to use my judgment based on all the planning that was going on to make a call one way or the other. I also realize that I am able to handle many details at once, although I think that is a prerequisite for all good medical writers! Finally, I became a much better delegator, just because there was far too much work for me to do alone. I was lucky to have a fantastic conference planning committee with whom to work!
Reports from the Open Sessions A total of 4 Career Enrichment Open Sessions took place in an airy and cheerful conference room located in the White River Gardens building at the Indianapolis Zoo. For Page 2 of 7
The Indiana Chapter the first time, the chapter conference offered these open sessions to its participants in addition to usual credit workshops. To appeal to different groups of medical writers, the open sessions were free to all registrants and covered various aspects of medical writing. The first three sessions featured topics ranging from writing regulatory documents (Risk Evaluation and Mitigation Strategies 101 by Kim Bullano) to health outcomes research (Health Outcomes and Patient-Reported Outcomes by Kathy Wekselman and April Naegeli) to reporting randomized controlled trials for peer-reviewed publication (Navigating the Current Medical Publications Environment by Heather Haley). In the last open session, a panel consisting four experienced medical writers discussed their medical writing jobs at unexpected places (Unexpected Places Medical Writers Work by Judi Pepin, Tracy Beck, Terry Rogstad, and Katie Merz).
Risk Evaluation Mitigation Strategy (REMS) 101 Speaker: Kim H. Bullano, PharmD, ParagonRx International, LLC By Margaret Perry, MA, CGC Kim H. Bullano, PharmD, of ParagonRx International, LLC, kicked off the Career Enhancement Open Sessions of the AMWA 2010 Indiana-Ohio Valley Chapter Conference with a terrific presentation entitled Risk Evaluation Mitigation Strategy (REMS) 101. The presentation defined and provided the background history of REMS, addressed its implications, and offered guidance on writing a REMS document. The FDA Amendments Act (FDAAA), signed into law on 27 September 2007, gave the FDA expanded authority regarding the safety of new and existing drugs. Under Title IX subtitle A FDAAA, the FDA has the authority to require pharmaceutical companies to conduct post-approval studies, to add new safety information to a product label, and to submit a REMS. Consequently, the FDA may now require a REMS for any new drug or biologic at any stage of the product lifecycle. The FDA will notify manufacturers if it requires a REMS, but companies may proactively submit a proposed REMS to the FDA if they believe the benefit/risk profile of a drug warrants this action. An approved REMS is enforceable, and if a company is noncompliant with its REMS requirements, it will be subjected to substantial penalties. A REMS has at least 5 elements that include a medication guide or PPI, communication plan, elements to assure safe use (ETASU), and timetable for assessment. As of 2 April 2010, approximately two-thirds of the 117 currently approved REMS consist only of medication guides and do not include the more complex ETASU.
AMWA Indiana Chapter Newsletter July, 2010
The REMS requirement poses multiple challenges for pharmaceutical companies. Companies must identify and dedicate resources with expertise in clinical, drug safety, biostatistics, medical writing, regulatory, legal and marketing to the implementation of a REMS under time constraints and with uncertainty about FDA expectations. Medical writers can play a key role in developing the tools and materials for REMS development and in preparing the REMS for FDA submission. The approach to writing a REMS is no different than the approach to writing any regulatory document. It is essential to gather background information on the drug using IND and NDA source documents such as the Clinical Summary of Safety, Investigator‟s Brochure, Draft Launch Label, Risks Profile, and Risk Management Plan. The submission team must decide what drug risks need to be mitigated by a REMS and then which REMS elements adequately address the drug‟s perceived risks. Once those key decisions are made, the next steps include developing a project plan and establishing a review process. The FDA website www.FDA.gov provides a list of currently approved REMS that serve as examples and a draft guidance, issued in September 2009, for the format and content of proposed REMS, its assessments, and proposed modifications. The REMS document consists of 2 parts – the proposed REMS and the REMS supporting document. The proposed REMS document is a high-level overview describing the goals and elements of the REMS that, once approved, is made publicly available on the FDA website. It serves as the basis for FDA enforcement. The REMS supporting document (SD) is more expansive, providing a thorough explanation of the REMS rationale and supporting information about the proposed REMS content. The table below presents outlines for each of these documents. Clearly, the most common approach to REMS to date is to propose a Medication Guide as the primary REMS element. Proposed REMS Document MedGuide Others Only I. Goals I. Goals II. REMS elements: -Med Guide -Timetable
REMS Supporting Document
II. REMS Elements: -Med Guide -Communication Plan -ETASU -Implementation System -Timetable
-Table of Contents -Background -Goals -Supplemental Information on Proposed REMS Elements -REMS Assessment Plan -Other Relevant Information
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The Indiana Chapter For those assigned to draft these documents, the recommended approach is to develop the REMS SD first with the input of the appropriate functional experts. The SD background section should characterize the drug‟s safety risks, include a discussion of the FDA‟s determinants for a REMS requirement, describe why a REMS is necessary, and demonstrate how the proposed REMS ensures that the drug‟s benefits outweigh its risk(s). The SD goals‟ section is the foundation of the REMS and is determined by the desired safety-related health outcome. The REMS elements for any drug will vary with the perceived risk(s) of the drug, and each submission team must determine which constellation of REMS elements is best suited to address the drug‟s risk(s). The FDA requires REMS assessments to be submitted to the FDA, at minimum, 1½, 3, and 7 years post-drug approval. Thus, the SD must provide a table with the expected number and dates of REMS assessments to be submitted to the FDA. Once the SD is drafted, the proposed REMS document can be initiated. Per Kim, it may take 6 to 12 weeks to develop a full document and all REMS elements depending on availability of key resources during peak submission activity and the scope of the risk. Obviously, once the proposed REMS document is submitted to the FDA, the company must then invest in the resources to implement and monitor the plan.
Health Outcomes and Patient-Reported Outcomes Speakers: Kathy Wekselman, PhD, RN, Camargo Pharmaceutical Services; April Naegeli, PhD, Eli Lilly and Company By Kristin Bullok, PhD Kathy Wekselman of the Ohio Valley Chapter began the session by briefly defining and noting how PatientReported Outcomes (PROs) are used. As stated by Kathy, a PRO is “any report of the status of a patient‟s health condition that comes directly from the patient, without interpretation of the patient‟s response by a clinician or anyone else.” A further insight into this definition was later provided by April Naegeli of Eli Lilly and Company that, not only are the responses not interpreted by another person, but the actual questions within the PRO should not be explained by another to the patient. Kathy then launched into a clear and well-focused presentation of how PROs are developed, emphasizing the importance of continual interaction with regulatory authorities during development and validation of the tool. But before delving into the details of PRO development, the obvious question of “What‟s so important about PROs?” should first be addressed. To answer this question, we
AMWA Indiana Chapter Newsletter July, 2010
need to jump to April‟s presentation, delivered during the second half of the session. April clearly emphasized that the primary benefit of health outcomes research in general and PROs in particular is a way to demonstrate to regulatory agencies, payers, providers, and, of course, patients whether a medicine‟s effect provides real world value. A PRO instrument allows for assessment of effectiveness and can compliment results from clinical trials, which assess a medicine‟s efficacy. April explained the difference between these two terms as addressing two different questions: “Efficacy analyses address the question of „Can this medication work?‟ A PRO addresses the question of „Does this medicine work in the real world?‟” While the question of efficacy leads to a binomial answer (is the null hypothesis accepted or rejected), questions of effectiveness dive into the complex matrix of whether any decreases in medical costs or use of medical resources are observed; whether the patient‟s quality of life, overall function, and/or work performance is improved; whether one medicine is more effective than another within the same class. Results from such instruments allow payers to establish reimbursement strategies, especially for newly approved medicines, based on ranking the medicine‟s effectiveness against current standard of care. These results also assess whether the patient‟s (and by extension the payer‟s) overall cost will be decreased with the new (most likely more expensive) medicine compared with current treatments. When considering this in light of the increasing pressure to decrease medical costs, it is no great stretch to understand the increasing importance agencies and especially payers are placing on inclusion of well-designed, validated, and implemented PRO instruments within heath outcomes research. So how are such instruments developed? This brings us back to Kathy. Development of well-validated and reliable PRO instruments is an arduous task, according to Kathy. Because such instruments often query patient‟s perceptions of change (i.e., subjective versus objective measures), PRO instruments typically undergo extensive development, testing, and modification before they are accepted as valid. One of the most fundamental assessments for a PRO instrument is “content validity” – whether the new PRO instrument actually measures what you THINK it is measuring. Another key validity test is construct validity – the verification that the framework of the instrument is valid. “For example”, Kathy explained, “if a patient‟s pain increases, the instrument should detect an outcome of decreased function.” Construct validity also assesses whether the instrument can identify patients with a disease versus those without. Finally, the PRO instrument also should demonstrate reliability (test, re-test, and repeat Page 4 of 7
The Indiana Chapter to ensure the same outcome is obtained) and the ability to detect a clinically relevant change. In short, the demand for accurate effectiveness data, in addition to demonstration of efficacy, is increasing from a regulatory, payer, and patient perspective. Such information can be obtained by well-validated and reliable PRO instruments. However, development of such instruments is not for the faint of heart. Before embarking on PRO development, Kathy cautions do not go it alone! Enlist an experienced health outcomes scientist and regulatory scientist before you begin.
Navigating the Current Medical Publications Environment Speaker: Heather Haley, MS, Haley Writing Solutions, LLC By Julie Beyrer, MTSC Medical writers are often familiar with the CONSORT statement for randomized controlled trials.1 But what many of us may not know is just how many CONSORT statements there are. (Answer: CONSORT has 7 official extensions and 4 unofficial extensions.) There is a consort for Randomized Controlled Trials Noninferiority/Equivalence Trials Abstracts Nonpharmacologic interventions Cluster trials Pragmatic Trials Reporting Harms Herbal Interventions Acupuncture Homeopathic, and Occupational therapy. Did you know there was a new CONSORT statement for randomized controlled trials in April 2010? Most open session attendees did not. The new CONSORT 2010 describes inclusion of new trial items, including:3 Why trial was stopped or ended All important “harms” or unintended consequences (CONSORT HARMS)4 Trial registration number Protocol availability Sources of Funding and other support. Ever checked out the EQUATOR network?2 You should if you are a medical writer involved in writing about any of the following topics: subgroup analyses, noninferiority/equivalence, health economics, observational studies, or adjudication committees. Some helpful publication guidance are shown in the following table:
AMWA Indiana Chapter Newsletter July, 2010
Challenge
Guidelines
Checklist (yes/no)
Randomized Controlled Trials
CONSORT 2010 + extensions
Yes
Observational study
STROBE
Yes
Systematic Review
PRISMA
Yes (Flow diagram too)
Meta-analyses
MOOSE, PRISMA
Yes
Quality Improvement
SQUIRE
Yes
Diagnostics
STARD
Yes
Infection Control Interventions
ORION
Yes
Historical Controls
Clin Cancer Res. 2007 February 1; 13(3): 972– 976.
No
Behavioral Health
TREND
Yes
Heather also briefly described other topics, including writing about subgroup analyses,5 noninferiority/equivalence trials,6 patient-reported outcomes, 7 health economics,8-11 the new clinical trials results posting requirements after the recently enacted United States Food and Drug Administration Amendment ACT (FDAAA),12 FDA‟s Guidance on Distribution of Publications with Off-Label Uses,13 and Good Publication Practices 2.14 So, what‟s a medical writer to do to navigate the current medical publications environment? As Heather stated during her session, publication guidelines are the tools of our trade, and there is probably a guideline for every challenge we face today. But never fear! The solution: you don‟t need to know all the guidelines, just where to find them. Heather‟s presentation left participants with a wealth of resources and references for finding the appropriate guideline(s)! References 1 http://www.consort-statement.org/database 2 http://www.equator-network.org/home/ 3 BMJ 2010;340:c332 4 Ann Intern Med. 2004;141:781-788 5 NEJM. 2007 ;357(21):2189-2194 6 JAMA. 2006 ;295(10):1152-60 7 http://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UC M071975.pdf 8 http://www.ispor.org/workpaper/practices_index. asp 9 http://www.ispor.org/workpaper/clinical_trial.asp 10 BMJ 1996;313:275-283 11 JAMA. 1996 Oct 23-30;276(16):1339-41 12 see http://www.clinicaltrials.gov/ for information regarding clinical trial results postings
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The Indiana Chapter Unexpected Places Medical Writers Work Speakers: Tracy Beck, PhD; Judith (Judy) M. Pepin, PhD; Teresa (Terry) L. Rogstad, MPH; Katie Merz, MA By Connie Ross, BS Perception of medical writing can be narrow and homogeneous. This seminar was a snapshot of four different medical writers and the variety of unexpected duties that comprise each career path. 1.
Tracy Beck, PhD, Eli Lilly and Company, Consultant, Medical Quality
Tracy is a medical and regulatory writer. Information and Communications Technology (ICT) and frequent interactions with outside Regulatory Affairs groups comprise Tracy‟s duties. Tracy developed a primary template for ICT synopsis and modifies it for various scenarios. A presentation in Maine, for example, required review of a 4-page law plus 19 pages of state requirements written in complex legalese. The Drug Information Association (DIA) group at Lilly works to navigate legal venues, so Tracy converted that information to understandable verbiage. Controlling organizations have differing standards and formats for required submission elements. Most states require a synopsis. The Federal Government prefers tables outlining information. When international work is required, Tracy utilizes web research to ensure accuracy with each country‟s requirements, as there is no international format standard. The group at Lilly has to be familiar with HL7 (Health Level 7) and work within its parameters, since HL7 is standardized language for a study. Tracy has no direct interaction with legislators, but does interact with journal editors. Persuasion is imperative in Tracy‟s medical writing. Her goal is to convey Lilly‟s position then explain each particular decision. Tracy expressed that her job incorporates a skill set beyond medical writing. It includes negotiation/persuasion, distilling complex medical information, and consistently articulating/providing back-up facts. She must be extremely knowledgeable with regards to the Clinical Trial Registry. 2.
Judith (Judy) M. Pepin, PhD, Procter & Gamble Company
Judy launched her career over 20 years ago via networking. Flexibility and the willingness to master new skills have set her apart and kept her a valuable asset during changing company milieu.
AMWA Indiana Chapter Newsletter July, 2010
Judy began her career as a post-doctoral drug research analyst writing white papers. She moved into medical communication encompassing adverse events in over-thecounter (OTC) medications. Judy advanced into the specialty of pharmaceutical respiratory and cardiovascular medications leading to regulatory and submissions writing. Judy returned to OTC medications 15 years later. Recently, Warner Chilcot bought 85% of P&G‟s pharmaceutical business. Judy now utilizes her skills in beauty care products and devices. Her current job is creating a database summarizing information gleaned during the past 18 years and integrating it for easy accessibility. This endeavor involves a product from Europe, so she is evolving her medical writing and project management skills in a different culture. Judy views her career development as strategically becoming the “Go To” person. She cultivates varied skill sets and exemplary organization and multi-tasking abilities. Her advice to colleagues is to be willing to do anything to get to where you want to be. 3.
Teresa (Terry) L. Rogstad, MPH, Hayes, Inc., Senior Medical Research Analyst
Terry‟s writing mission is to drive better healthcare decisions. Hayes advisory services are used by healthcare organizations, hospitals, and employers/employees making healthcare choices. The evaluation of drugs, devices, procedures, and diagnostic tests provide information to attain that goal. Terry generates evidence-based reports. Her writing includes health technology assessments, brief single-product reviews, genetic test evaluations, and news service. Terry‟s position requires graduate level training or equivalent expertise in epidemiology, biostatistics, health sciences, health economics, pharmacology, or biological science applicable to clinical medicine. A strong scientific background, knowledge of clinical trial design and statistics, and experience searching bibliographic/regulatory databases is required. Terry‟s career began with a degree in German/Pre-med. She worked in Continuing Medical Education administration, organized medicine, and quality improvement before finding her job at Hayes while in graduate school. Terry works out of her home office attending meetings by phone/web and enjoys company support such as article retrieval, technical editing, and information technology. When writing, Terry chooses a topic from the available list and then utilizes a literature search for research design, sample size, comparator, indication, and follow-up. She analyzes the findings and quality of studies, synthesizes the information, and ultimately assigns the proprietary „Hayes Rating.‟ She uses a prescribed outline but little prescribed language.
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The Indiana Chapter Terry views her job as encompassing the best of both worlds: flexibility, like freelance, with the guaranteed income and support services of a corporation. She suggested webinars and continuing education to improve presentation and project management skills. 4.
Katie Merz, MA, Healthy Advice Networks, Creative and Editorial Director
With a BA in English and a Masters in Education, Katie began her medical writing career by editing public health information. A former contact and what she calls luck helped her land her current position. Healthy Advice provides information for physicians‟ offices. The pharmaceutical industry sponsors the information, which covers pharmaceuticals, over-the-counter medications, and specific medical conditions. Katie‟s job has a creative twist. Digital signage for waiting rooms involves animated short messages designed to capture the patient‟s attention and get a point across in the few minutes before that patient sees the physician. Digital signage covers five areas: primary care, obstetrics/gynecology, dermatology, arthritis, or cardiovascular disease. Printed brochures and handouts for the exam rooms cover four medical areas: primary care, pediatrics, urology, and gastroenterology. All must be written at a 6th to 8th grade reading level. Healthy Advice also produces a magazine written at a higher reading level. Each aspect of Katie‟s job has three components: physician, technical, and patient education. The goal is brand/logo recognition resulting in increased sales. These related but disparate areas create a difficult business model for Healthy Advice. The research department gauges the return on investment by tracking prescribing data of physicians and OTC sales via patient surveys. Katie emphasized diversification beyond print in anticipation of integrating more mobile, text, and phone applications. Given that job security no longer exists in the current economic environment, career development embodies value in navigating the ever-changing and unstable healthcare industry.
The Best Of – Highlights of Local and National AWMA News
information of this event will be posted at the chapter website http://www.hoosieramwa.org/events.php. ♦ BELS Exam: Victoria Elzey, an Indiana AWMA Chapter member and Senior Medical Editor at inVentiv Clinical Solutions, LLC., passed the BELS Exam held at the April Chapter Conference. Congratulation Victoria! ♦ Registration for National conference opens on July 26: The registration brochure will be posted on the AMWA website on the 1st week of July. Please find more information at http://www.amwa.org.
2009-2010 AMWA Indiana Chapter Board: President:
Kristin Bullok
President-Elect:
Phadungchom (Pam) McClelland
Secretary:
David Caldwell
Treasurer:
Julie Beyrer
Membership Chair:
BethAnn Garni-Wagner
Program Chair:
Michael Mihm
Education Chair:
Anne Wolka
Scholarship Chair:
Elaine Crabtree
Newsletter Editor:
Qing Zhou
Program Committee: Education Committee: Past President:
Julie Beyrer
Contact any Board member with questions or ideas for the chapter. See the website for contact information: www.hoosieramwa.org.
About AMWA: The American Medical Writers Association (AMWA) is a national organization for writers, editors, and other professionals in medicine and science. The association was founded in 1940 and has regional chapters throughout the United States and Canada and members in 26 countries throughout the world. Through an extensive educational program, various publications, and unparalleled opportunities for networking, AMWA encourages and enables its members to extend their professional expertise.
♦ Upcoming Chapter Event: Our Program Committee is planning for a panel presentation on globalization which will be held in late August. Please watch for the email announcement of this event in your inbox. More
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