F a l l 2 0 07
Look inside
for your chance to create a healthier tomorrow by participating in a clinical research study today!
500 Helendale Rd., Suite L20 Rochester, NY 14609
LIFECYCLE OF A DRUG: A LONG AND WINDING ROAD 3 TO 6 YEARS Step One: Discovery Step Two: Early Testing
CLINICAL
RESEARCH HELPS SET STANDARDS OF CARE
STUDY PARTICIPATION OPPORTUNITY
How does your doctor know what treatment to use for your medical problem? Education and experience play a big part in medical decisionmaking; so do standards of care. Standards of care are treatment guidelines that are judged by medical experts to be effective and appropriate, and are widely used. These standards represent what is currently known to be the best available treatment strategy for a given medical problem. Clinical research helps to establish new standards of care. A clinical research study often will test a new idea for a standard of care against an established standard. Effective treatments that are approved by the FDA often become the new standards of care for patients. Volunteers who take part in clinical research studies are helping to set new standards of care for themselves and future generations.
Discovery – Scientists test compounds and their effectiveness to fight against a 6 TO 7 YEARS certain disease or medical condition. They Step Three: Studies in Humans Begin start with as many as 10,000 compounds, Step Four: Studies in Humans Expand and search for the most promising. Some efforts hit a dead end, but others lead to more testing.
ONE-HALF TO TWO YEARS Step Five: Approval for Wider Use
If you have high blood pressure, you can help find new treatments. A new research study will evaluate the effectiveness of two approved medications in different dosages and combinations to treat high blood pressure. If you’re over 18 and have or think you have high blood pressure, you may qualify. Participants will receive free study medication and exams.
Come be part of the solution. learn more about our current studies and the opportunity for you.
See if you qualify by calling
585.288.0890
Advancing medicine. Changing lives. 500 Helendale Rd., Suite L20 Rochester, NY 14609 www.rcrclinical.com
It takes 10 to 15 years from the time scientists discover the idea for a new medicine until it is proven to be safe and effective for people. Here’s an overview:
Some information for this article was adapted from “Drug Discovery and Development,” published by Pharmaceutical Research and Manufacturers of America, 2007.
Early Testing
– The number of compounds is ultimately narrowed down from many to between one and five good “candidate drugs.” Testing for safety is done on living cells, in animals, and via computer modeling. This “preclinical” testing leads to the next critical stage, clinical research studies involving humans. Before these begin, researchers report their preclinical testing results to the U.S. Food and Drug Administration (FDA) with details about how they expect the drug to work in humans. They then determine how to make enough of the drug for human testing and develop a plan for clinical research studies.
Studies in Humans Begin –
After the FDA approves the study plan, and before it grants final approval of the drug for use by the general population, three phases of testing are carried out with an increasing number of human volunteers.
Phase I involves 10 to 100 healthy volunteers. This crucial step helps researchers learn the right dosage, check for safety profiles in humans, and observe how the drug behaves in people.
Studies in Humans Expand – Phase II studies test the drug in 100 to 500 volunteers who have the condition or medical problem being studied. Researchers monitor the volunteers carefully to evaluate the drug’s safety. Phase III studies are much larger, with 1,000 to 5,000 volunteers. In this phase today, many Phase III studies are conducted worldwide. Here, the final decision is made about the drug’s safety and effectiveness.
Approval for Wider Use – Successful testing in carefully controlled clinical research studies means the drug is finally ready for review – and hopefully approval – by the FDA. The FDA has a rigorous review process, which includes examination of clinical research study data by both internal and external experts. All in all, the process by which a new drug reaches patients is carefully and expertly conducted, with a singular goal: new and better treatments. Safety is the overriding concern during the entire clinical research process.
To learn more about clinical research studies, contact
ROCHESTER CLINICAL RESEARCH
585-288-0890
500 Helendale Rd., Suite L20, Rochester, NY 14609
585-288-0890 www.fspi.info • 866-913-7098
www.rcrclinical.com
voice
VOLUNTEER’S “TO HELP FIND A BETTER WAY”
DIANNE AND ERNIE BISHOP
When it comes to volunteering for clinical research studies, Dianne and Ernie Bishop are veterans. Ernie participated in his first study nearly ten years ago, and has been involved in a couple more since then. Dianne’s volunteered in two studies over the past few years.
explains. “My doctor recommended it. I was checked out to see if I qualified and there were lots of checkups during the study. They are very thorough about that.”
The Bishops, in their late 60s, helped with studies that focused on medicines for controlling high blood pressure and high cholesterol, conditions they both live with and share with millions of others. The way they see it, they are benefiting themselves and others at the same time.
“They watch you so closely. they see you so often, you feel absolutely safe,” she says. “You can ask questions anytime.”
Dianne also found the care and oversight during the studies to be comforting.
FAMILIAR
FACE WELCOMES RESEARCH STUDY VOLUNTEERS
Dianne and Ernie understand that new medicines wouldn’t become available without the exhaustive testing that is done through clinical research. They “Maybe I can help find a better way to treat the have encouraged friends and family to consider problem and also help myself,” Dianne says. “It’s a volunteering, too. win-win situation.” “I tell others it’s a wonderful thing to do,” says Ernie’s first study, in 1998, involved a new Dianne. cholesterol medicine. Adds Ernie, “I don’t know if you’d call it noble, but “I didn’t know anything about clinical research,” he it’s important to bring new medicines along.”
STUDY PARTICIPATION OPPORTUNITY
Did you know - researchers at RcR have conducted trials with the following medications that have been approved by the FDA and are now on the Market: DISEASE
MERVYN WEERASINGHE, MD
MEDICATION
High Blood Pressure Tekturna® Diabetes Byetta® Smoking Cessation Chantix® Weight loss Alli®, Xenical® Insomnia Lunesta® Arthritis Ultram ER®, Celebrex® Currently Enrolling Patients in the following studies: Smoking Cessation Type 2 Diabetes Weight loss for Diabetics Obesity Adolescent Migraines Adult Migraines - Ages 12-17 Hypertension Gout Osteoarthritis Insomnia Flu Vaccine Pneumonia Vaccine High Cholesterol
STUDY PARTICIPATION OPPORTUNITY
FOCUS ON DIABETES
Many patients are surprised to see Mervyn Weerasinghe, MD, when they come for their first appointment on one of his clinical trials. Dr. Weerasinghe was a Primary Care Physician for many years at the Rochester Medical Group before he began his clinical research and medical administrative career. His patients remember him well as a very caring and detail-oriented physician.
diabetes, obesity, high cholesterol and high blood pressure, and their contribution to heart disease.
“Clinical research gives me the opportunity to work with thought leaders throughout the world Dr. Weerasinghe’s medical career includes numerous on these very important medical conditions,” he says. appointments around the region. He was President Clinical research is responsible for so many and Medical Director of the Medical Group; Medical contributions that help medical professionals to Director of Clifton Springs Hospital; and Associate better understand and treat the major health Medical Director of Greater Rochester Individual problems affecting people today, Dr. Weerasinghe Practice Association. He also is a past President of the notes. Monroe County Medical Society. “I see the progress that we are making, and am An experienced leader in the clinical research encouraged by the direction of research,” he says. community, Dr. Weerasinghe has served as Principal “Studies that we are now conducting in diabetes are Investigator or Sub-Investigator on more than 400 addressing the prevention of the onset of type 2 research studies. He has directed studies in the areas diabetes. Rochester Clinical Research also is a leading of hypertension, diabetes, weight loss, asthma, research center on a trial for the prevention of high osteoarthritis, hormone replacement therapy, and blood pressure. These long-term studies may be able smoking cessation. He is particularly focused on to give us better treatments for the future.” Many people are surprised to learn that treating diabetes involves more than keeping blood sugar levels within range. In fact, treating diabetes also includes monitoring and treating total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, blood pressure, and weight. Type 2 diabetes has two features: insulin resistance (a condition of low insulin sensitivity in which the body cannot successfully lower the blood sugar); and failure of the insulin-producing cells of the pancreas to make enough insulin to meet the body’s demands. “The epidemics of diabetes and obesity are clearly escalating in the United States.” said Center for Disease Control Director Dr. Jeffrey P. Koplan. “If we continue on this course for the next decade, the public health implications in terms of both disease and health care costs will be staggering. We must intensify our efforts to prevent and treat these epidemics.” The Medical Director of Rochester Clinical Research, Dr. Mervyn Weerasinghe states that promoting healthy lifestyles and focusing on early detection of these conditions should be a priority in today’s health care environment. “New technology has given us the opportunity to test participants with just a few drops of blood to receive immediate results on their blood sugar and lipid levels. We will provide people with information to wisely choose their next course of action”.
STUDY PARTICIPATION OPPORTUNITY