Clinical trials are mandated by the Federal Drug Administration (FDA) for all new drugs, medical devices, vaccines, and gene therapies in the United States. Study participants need to fully understand the study, their rights, the potential risks and benefits, and what is expected of them.
Sponsors of clinical studies can include pharmaceutical companies like Merck and Pfizer, academic medical centers such as Duke and Stanford, and Federal agencies National Institutes of Health and the U.S. Department of Veterans Affairs. Selecting a location for clinical trial research is often based on access to specific equipment, physician expertise, and/or sample patient populations.
Participation: Finding and enrolling in a clinical trial involves several important steps as well as personal factors.
Need for Diversity: A clinical trial should reflect the population most likely to use the drug tested if it’s approved.
Informed Consent: Knowing what you’re signing up for is crucial for clinical research to be considered ethical.
Compensation: Time, effort, and sometimes even physical risk are reasons trial participants may receive payment.
Associated Costs: Trial participants may incur costs related to travel, time, health care, or personal commitments.
Insurance Coverage: Coverage for trial-related expenses varies depending on the type of insurance, the trial’s nature, and where it takes place.