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DSI Newsletters, Issue 22:
What You Can Expect: Volunteering for a Study
The Drug Study Institute (DSI) is a primary care investigative research facility dedicated to Quality Investigational New Drug Studies. Since 1997, we have worked with volunteer-patients to promote access to tomorrow's wonder drugs today (before the FDA certifies them safe and effective) in an atmosphere that maximizes benefits and comfort. In the process, our patients learn about their diseases — about improving their health. As part of our care program, it is our goal to teach patients enough medicine to empower them to make improved healthcare decisions.
Drug study volunteers help in the development of medical therapies and even cures for life-threatening and chronic diseases.
Before a pharmaceutical medicine becomes available in drug stores, it is subjected to deliberate scientific scruitny. A typical drug goes through ten years of testing before it's available on the drug store shelves.
The Drug Study Institute in Jupiter, Florida, helps drug companies study their drugs so that they can get them on the market. We have a special way of doing it that minimizes risks while maximizes benefits. Additionally, all of our new drugs are being investigated in an advanced trial phase — meaning they've been studied for a long time. Your safety is our first, last, and every concern in any experimental drug study.
...to participate in a clinical trial for a number of reasons. You may get involved in a trial because you simply want to help in the advancement of science. Or you may be suffering from a disease for which a good treatment does not exist presently. Or you may not have health insurance, and clinical trials are a way to get study-related medical care.
Whatever the reason, your participation is helping in the development of medical therapies, which may offer better treatments for everyone. Without volunteers, we couldn't advance medicine and bring new and better drugs to the market. People who join a clinical trial help themselves and others live longer and healthier lives now and in the future.
Volunteers typically receive compensation for time and travel, along with study drug and study-related medical care at no expense.
What You Can Expect
As a volunter in a DSI program, you and your medical condition receive very close attention. You will notice that you will spend more time with the doctor more often than regular care. The opportunity to learn more about yourself, to improve your health, and to benefit society is every present in our drug studies.
Of course, your privacy is protected as well. Your medical records are strictly confidential. The trial data that is provided to the pharmaceutical company and the FDA will not include your name or the names of other individuals participating in the study.
Ultimately, we want to provide you with an overall good experience so that you will consider volunteering for another trial in the future. Without your participation, we couldn't get new drugs to market and help those who need them most.
Joseph Saponaro, MD...
...DABIM, FACP, CPI, CCI, CCRI, CCRC, CCRP, is the Principal Investigator at DSI. A board-certified internist, Dr. Saponaro is a diplomat of the American Board of Internal Medicine, Fellow American College of Physicians, and a member of the American College of Preventive Medicine (ACPM). He earned a degree as a Certified Clinical Research Coordinator (CCRC) and Investigator (CCRI) from the Association of Clinical Research Professionals (ACRP) and a degree as a Certified Clinical Research Professional (CCRP) from the Society of Clinical Research Associates (SoCRA).
At DSI, Dr. Saponaro currently oversees about 20 investigational new drug studies per year.
Please visit our Web site at www.DrugStudy.MD and call 561-575-1212 for a complimentary hour consultation with Dr. Saponaro at the Jupiter Preventive Medicine Center, conveniently located on the campus of the Jupiter Medical Center, to discuss your health. The Drug Study Institute is looking forward to working with you on our next Investigational New Drug Trial.
All clinical trials are reviewed by the U.S. Food and Drug Administration (FDA) and by Institutional Review Boards comprised of doctors, other healthcare providers and sometimes members of the clergy.