US proposals would require greater disclosure of clinical trial dataBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g7103 (Published 24 November 2014) Cite this as: BMJ 2014;349:g7103
- Michael McCarthy
Under two proposed rule changes the US government will expand the number of trials that must report clinical trial data. This would include trials of drugs, devices, or biological products regulated by the Food and Drug Administration (FDA), regardless of who funds or conducts them, and any trials funded by the US National Institutes of Health (NIH).1
The first proposal, which clarifies a provision of the Food and Drug Administration Amendments Act of 2007, would require reporting of all summaries of clinical data from trials involving FDA regulated products, whether or not the agency had approved them or cleared them for marketing.
Under current rules, reporting of summary results is required only …