All clinical trials have one thing in common: the volunteer subject. Without the participation of human volunteers, no new drugs or therapies would be available to treat those suffering from disorder and disease. Indeed, the U.S. drug and device approval system, under the direction of the U.S. Food and Drug Administration (FDA) requires that any new drug or device be thoroughly tested before being made available to the general public. This makes the volunteer subject the most important part of the approval process. For this reason, volunteering for clinical research has been described by some as medical heroism.
Why do people participate in clinical trials?
Clinical research participants are volunteers in the truest sense. By their participation they help make potential newer therapies and treatments available – not only to themselves but others who follow. Participants also gain early access to cutting-edge therapies and find a more active role in their own healthcare.
Benefits and risks
What are the benefits and risks of participating in a clinical trial? Because clinical trials are often designed to test the effectiveness and safety of new drugs and devices, benefits cannot be guaranteed. Regardless of the personal benefit however, participants enjoy the satisfaction of having contributed to the growing knowledge and understanding of a disease and furthering the progress of medical science, which may benefit others in the future.
Novant Health Clinical Research is governed by, and fully compliant with, regulations emanating from the FDA and other regulatory bodies that assure that risks are minimized and fully disclosed to participants in the informed consent process.
What are the costs of participating in a clinical trial? Usually, costs directly related to the clinical trial are provided without charge by the sponsor of the clinical trial. Medicare's national coverage decision of 2000 provided coverage for routine costs associated with clinical trials and costs due to complications associated with participation. Other commercial payers have individual policies regarding coverage for clinical trials. It is recommended that you check with your health insurance carrier regarding costs related to clinical trials.