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Why Participate in Clinical Trials – Aren't They Risky?

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Have you ever wondered about the “clinical trials” on which medication, medical device, and other therapies are approved? Clinical trials are research studies in which people volunteer to test new drugs or medical devices within the context of scientifically based and carefully designed protocols reviewed by carefully for scientific rigor and safety. These standards protect patients and help produce reliable study results. Doctors look at the results of clinical trials to learn whether a new treatment is safe and effective. These kinds of studies are needed to develop new treatments for serious medical problems such as heart disease.1 Clinical trials produce the best data available for healthcare decision making.

Clinical trials have the potential to offer benefits to those who participate. For one thing, participants may gain access to new treatment options or medical devices that are not widely available yet. Clinical trials can also give participants a feeling that they are helping to advance medical science – which, indeed, they are.1

There are different types of clinical trials and they are conducted in progressive phases (from stage I through IV). Once a clinical trial goes through all the stages and proves that a therapy is safe and effective, the U.S. Food and Drug Administration (FDA) must approve that therapy for the public.1

Participation in a clinical trial is 100% voluntary. If you meet the requirements for a clinical trial, you are completely free to decide if you want to take part in it. Talk to your doctor about whether a clinical trial may be right for you. You can also learn more about clinical trials at clinicaltrials.gov.1

It’s reassuring to know that researchers and physicians at the Temple Heart & Vascular Institute are international leaders in the development of new therapies and technologies to treat heart disease and related conditions. In fact, our work spans the basic science laboratories of the Lewis Katz School of Medicine at Temple University to the patient care areas (clinic, hospital and operating rooms, and procedure labs at Temple University Hospital).2 We call this “bench to bedside” research – taking a discovery from the “bench” (the science lab) to the “bedside” (of the patient who has just received the treatment.)

In addition to more basic research, the Temple Heart & Vascular Institute is also a hub of clinical trials that are testing the effectiveness of new medications, innovative surgical techniques and the latest medical devices. The Institute’s robust clinical trials program enrolls numerous patients in clinical trials each year.

Becoming a participant in a clinical trial is a vital function that patients who qualify can fill. As scientists and clinicians, we thanks all those patients who you to consider helping us write the next chapter in advancing cardiovascular care.

References:

  1. About Clinical Trials. Accessed June 13, 2017. 
  2. Research Focus Areas. Accessed June 13, 2017. 
  3. Search Clinical Trials. Accessed June 13, 2017.
Daniel Edmundowicz, MS, MD, FACP, FACC

Daniel Edmundowicz, MS, MD, FACP, FACC

Dr. Edmundowicz is the Medical Director of the Temple Heart & Vascular Institute and has a special interest in cardiovascular disease prevention. He is national authority on the applications of atherosclerosis imaging to cardiovascular disease prevention and risk factor modification. He has lectured widely and published more than 80 peer-reviewed articles. He leads public health and epidemiologic studies and participates in multi-center clinical trials. Dr. Edmundowicz is a Fellow of the American College of Cardiology and past president of the ACC’s Pennsylvania Chapter. He is also a member of the American Heart Association and National Lipid Association.

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