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Clinical Trials

Clinical Trials

Clinical research used by the FDA to approve and monitor drugs, devices, and diagnostics must be well-designed and transparent.

Patients and clinicians deserve access to information on whether prescription drugs, medical devices, and diagnostics are safe and effective – and clinical trials are how we get this important data and evidence. Over time, there has been a decline in the quality of clinical trials used by the Food and Drug Administration (FDA) for approvals. This has led to use of drugs, devices, and diagnostics that have little benefit to patients and introduced greater confusion for providers and patients in deciding what medical products are best for them.

We aim to strengthen innovation through stronger FDA approval standards, greater clinical trial transparency, and accountability into the FDA’s reviews of clinical data, as well as assuring that insurance coverage reflects available clinical evidence. We advance these policy changes through research, policy development, technical assistance, advocacy, and education.

Amount of physicians believe that the FDA threshold for drug approval has fallen in the past 5 years Source
Approximate number of clinical trials that remain unreported, often because the results are negative Source
Average number of drugs approved through accelerated approval have yet to confirm their clinical benefit Source