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# Placebo Trials Can Put Subjects at Risk: New Study
- URL: https://www.fdaweb.com/placebo-trials-can-put-subjects-at-risk-new-study/
- Published: 2018-04-24T12:00:00.000Z
- Updated: 2026-09-15T00:00:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141283

Public Citizen says its study published in the open access *Journal of Clinical Trials* finds that using placebos in clinical trials testing new medications for life-threatening diseases for which proven effective treatments already are available can put human subjects at increased risk of harm. A [news release](https://www.citizen.org/media/press-releases/clinical-trials-supporting-fda-approvals-new-medications-life-threatening?ref=fdaweb.com) (contains link to study) examined treatment provided to control subjects in 508 trials that supported FDA approval of new medications for nine life-threatening diseases. Of the trials, 201 (40%) were placebo-only controlled.

“Our finding that placebo-only controlled trials are commonplace, even in trials enrolling patients with severe, life-threatening diseases, demonstrates the need for FDA to revise its guidance on the use of placebos in such trials whenever proven alternative treatments are available,” says Public Citizen Health Research Group senior adviser **Sidney Wolfe**. “Moreover, trials with placebo-only control groups should require much greater scrutiny by sponsors, researchers, institutional review boards, and FDA.”