NIH Instructs Drug and Medical Device Manufacturers to Post Missing Trial Data
In response to a federal court ruling made in February, the National Institutes of Health (NIH) has issued new rules for data transparency that mandate clinical trial sponsors submit missing data for studies conducted between 2007 and 2017.
According to a July 30 NIH draft letter describing the ruling, no definite deadline has yet been set for the submission of data for trials of currently approved drugs or devices, but the NIH does indicate these data should be provided “as soon as possible.” For trials of investigational drugs or devices that are not currently approved, the NIH states the trial data must be submitted within 30 days following the data of approval, licensing or clearance by the FDA.
Trial sponsors who fail to submit required results information could face monetary penalties, yet specific fines were not mentioned in the NIH letter. In addition to imposing fines, the NIH or FDA may also withhold remaining grant funding from noncompliant clinical trial sponsors.