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FDA mulling whether patients should have to pay to join clinical trials

| | August 15, 2019
clinical trials
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This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

Some [clinical trials] plan to ask participants to pay $7,000 or so to enroll. Another wanted to ask for upward of $250,000.

These studies have caught the attention of federal regulators. The Food and Drug Administration recently asked a federal advisory committee to consider how the research community should think about such trials, an agency spokesperson confirmed. Members of that panel are now drafting recommendations on the issue. And the National Institutes of Health asked the committee to consider whether its existing resources to guide patients considering a clinical trial are adequate for scenarios in which they are being asked to pay, a spokesperson for that agency confirmed.

FDA regulations permit such trials in “extraordinary circumstances,” such as when the drug being tested has a price tag so high that the trial couldn’t otherwise be run. 

But experts say these trials are ethically fraught for a number of reasons: At worst, they run the risk of being a guise for an enterprise looking to profit from desperate patients. But even when intentions are sound, the trials are likely to only enroll those patients who can afford to participate, thereby skewing the results.

Read full, original post: Amid rising concern, pay-to-play clinical trials are drawing federal scrutiny

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