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FEATURED REPORT

Clinical Trials

- May 18, 2018
Can public participation be expanded?
Featured Report

Clinical trials are designed to answer questions about the safety and effectiveness of experimental drugs, medical devices, vaccines and behavioral therapies. The U.S. Food and Drug Administration relies on trials when considering whether to approve new medical treatments or new uses for existing drugs and devices. But the clinical trials system in the United States is in crisis. Few patients participate, causing nearly a fifth of trials to shut down early or before they even begin. In addition, trials are becoming increasingly long, complex and costly. The net effect, many medical experts warn, is that health care innovation and advances are threatened. Analysts have proposed some controversial remedies: requiring drug companies to publicly release more trial data to increase trust in their results, broadening eligibility requirements to attract more participants, involving patients in the design of clinical trials and incorporating the use of smartwatches and other wearable biosensors to gather data, which could make trials easier and cheaper to conduct.

Funding for Clinical Trials

The White House wants to cut the National Institutes of Health budget by 6 percent.

Complexity Increases

Trial procedures are growing more elaborate.

Umbrellas and Baskets

New approaches make it easier to effectively recruit cancer trial participants.

Right to Try

The terminally ill want access to experimental drugs outside of clinical trials without FDA permission.

 
1740s–1930sResearchers use control groups to compare therapies in clinical trials; drug regulation grows.
1940s–1960sAcceptance grows for “randomized” clinical trials, which assign test subjects randomly to receive different treatments.
1970s–1980sNew laws protect human research subjects as clinical trials evolve.
1990s–PresentTrial sponsors are required to make more trial data public.
   

Should terminally ill patients have the right to try experimental drugs outside of a clinical trial without FDA approval?

Pro

Starlee Coleman
Senior Policy Adviser, Goldwater Institute.

Con

Lisa Fullam
Professor of Moral Theology, Jesuit School of Theology, Santa Clara University.

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