FAQs

A. Clinical trials are conducted by physicians, investigators and researchers at various organizations including local research institutions, hospitals and universities.

A. Participation in a clinical trial often provides patients access to potential new treatments and to expert health care at leading institutions. By participating in a clinical trial, you play an active role in your health and the health of others by contributing to scientific knowledge that may lead to potential new medical treatments for future patients.

A. As with any medical treatment, participation in a clinical trial offers benefits and risks. Researchers conducting these trials will clearly explain the potential benefits and risks so you can feel confident about making the best decision. Participants always reserve the right to end their participation at any time, even if the study is not complete.
All clinical trials must be approved by an Institutional Review Board (IRB). An IRB is made up of physicians, researchers and members of the local community. Its role is to make sure that the study is ethical and the rights and welfare of participants are protected. This includes ensuring high safety standards and processes are followed, and that risks are minimized and reasonable in relation to potential benefits.
The Food and Drug Administration (FDA) also plays an important role in the clinical trials process, ensuring the safety of participants, qualifications of researchers and the safety and efficacy of the studies.
It’s always best to discuss with your physician whether a clinical trial is right for you.

A. Reasons certain populations are underrepresented in clinical trials vary and may include lack of understanding of the clinical trial process, lack of awareness of which clinical trials are available to them, or lack of clinical trials in underserved areas.

A. It’s important for individuals of varied races, ethnicities, ages, gender and sexual orientation to participate in clinical trials. We know that some medicines impact people differently. For example, certain blood pressure medications are less effective in African Americans than other races. Inclusion of participants from diverse backgrounds furthers research and helps find better ways to fight diseases that disproportionately impact these populations.
The current clinical trial system faces many challenges in recruiting and retaining eligible participants. According to the Center for Information and Study on Clinical Research Participation, only 6% of clinical trials are completed on time and 50% of clinical research sites enroll one or no patients in their study. Delays in trial completion lead to delays in regulatory review and approval process- which ultimately delays patient access to new, potentially life-saving medicines.