Clinical Trial Data Sharing: What Models Are Most Responsible?
An article published in the New England Journal of Medicine discusses how to share clinical trial data responsibly.
"Sharing participant-level data may bring exciting benefits for scientific research and public health but may also have unintended consequences. Thus, expanded data sharing must be pursued thoughtfully," states the article. The authors go on to suggest potential frameworks for broad sharing of participant level data:
• Open-access with data sets and documentation freely downloadable;
• Requiring data requesters to submit research questions before allowing access to data;
• Release data with trial sponsors controlling decisions about data releases;
• Independent board to evaluate data requests, impose and enforce conditions on use.
"A key premise of the sponsor-review and learned intermediary models is the balance of benefits and risks of each data request should be assessed. This framework may seem an uneasy fit with a simple desire for complete data transparency. However, in some instances, transparency can do more harm than good, and a trustworthy process is needed to assess and modulate risk case by case," states the report.
As data sharing models are developed, researchers and physicians will pay attention to the legal implications and ethical perimeters for reporting outcomes and disclosures.
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