Clinical Trials (cont.)

Medical Author:

Melissa Conrad Stöppler, MD

Melissa Conrad Stöppler, MD

Melissa Conrad Stöppler, MD, is a U.S. board-certified Anatomic Pathologist with subspecialty training in the fields of Experimental and Molecular Pathology. Dr. Stöppler's educational background includes a BA with Highest Distinction from the University of Virginia and an MD from the University of North Carolina. She completed residency training in Anatomic Pathology at Georgetown University followed by subspecialty fellowship training in molecular diagnostics and experimental pathology.

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Medical Editor:

William C. Shiel Jr., MD, FACP, FACR

William C. Shiel Jr., MD, FACP, FACR

Dr. Shiel received a Bachelor of Science degree with honors from the University of Notre Dame. There he was involved in research in radiation biology and received the Huisking Scholarship. After graduating from St. Louis University School of Medicine, he completed his Internal Medicine residency and Rheumatology fellowship at the University of California, Irvine. He is board-certified in Internal Medicine and Rheumatology.

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In this Article

• Clinical research and clinical trials facts
• What is clinical research?
• Why is clinical research important?
• What are clinical trials?
• What are the phases of a clinical trial?
• How can one find out what clinical trials are currently being conducted?
• How is a clinical trial performed, and what sort of preparation is needed?
• What is informed consent?
• Is patient privacy maintained in a clinical trial?
• Who can participate in a clinical trial?
• Are people paid for participating in clinical trials?
• What are the pros and cons of participating in a clinical trial?
• Can a person leave a clinical trial once it has started?
• Who sponsors clinical trials?
• What happens after a clinical trial is completed? Is there follow-up care?
• Clinical Trials Index

What are the pros and cons of participating in a clinical trial?

The benefits of clinical trials are many and range from taking an active role in the management of one's own health care, helping others by aiding the process of knowledge acquisition and development of enhanced treatments, being cared for by leading health-care teams in a given field, and in some cases, receiving access to new treatments before they are approved. However, there are also risks, including side effects of drugs and risks of any procedures that may be performed. In some cases, clinical-trial participation may require more frequent doctor visits or hospitalizations than standard care, and you may have to travel to a study site that is farther away than your local health-care practitioner's office.

Some questions you may want to ask before participating in a clinical trial include the following:

• What is the purpose of the trial?
• Is a new type of treatment being tested? How does this differ from the accepted or standard therapy for my condition?
• Has the drug or treatment ever been tested before?
• How will participation impact my daily life and schedule? Will it be necessary to be in the hospital?
• What are the risks and possible side effects of the treatment?
• Who will pay for the treatments? Will I receive reimbursement or any type of compensation for my time or expenses?
• How long is the trial expected to last?
• How will I receive results of the trial, and how will I know if the treatment is successful?

Can a person leave a clinical trial once it has started?

An informed consent document is not a legal contract that requires participation in a study for the length of a study. A participant is free to leave a clinical trial at any time.

Who sponsors clinical trials?

Clinical trials can be sponsored or funded by a variety of organizations or individuals. Federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA) frequently fund and sponsor clinical trials. Additionally, clinical trials may be sponsored by medical institutions, charitable foundations, advocacy groups, physicians, and/or biotechnology or pharmaceutical companies.