In a recent editorial, the editors of the journal Nature Medicine flagged several interesting developments in the world of clinical trial transparency:
- A proposed change by the US Department of Health and Human Services would tighten up existing rules for the submission of data to ClinicalTrials.gov by requiring data to be reported regardless of whether the treatment has been approved by the Food and Drug Administration (FDA).
- The US National Institutes of Health (NIH) has proposed a change that would require all clinical trials it funds to report data, regardless of whether these are subject to the FDA Amendments Act of 2007 or not. This would mean, among other things, that phase 1 studies funded by NIH would in future be required to report their data.
- Following a recent STAT investigation showing that academic trial reporting rates are even worse than those of biopharmaceutical companies, academic medical institutions such as the Memorial Sloan Kettering Cancer Center have recently expressed their intention to improve their reporting.
The editorial concludes that:
Regulatory agencies have the duty and the responsibility to fully report clinical trial results and enhance the transparency of clinical research. Institutions and industry should get onboard and both offer incentives and shift the mentality of investigators to overcome hesitation to share trial results. The end goal could not be more worthy.
Nature Medicine’s editorial was published on 4th August 2016. Its full text can be found here.