The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may need to post certain study results for 10 years’ worth of clinical trials (2007–2017), which the US Department of Health and Human Services (HHS) had previously excluded from the requirement.
By way of background, the 2007 FDA Amendments Act (FDAAA) required that HHS include certain study results, referred to as basic results, for approved drugs and biologics on ClinicalTrials.gov. Clinical study sponsors and investigators were required to submit these study results within one year of the estimated or actual study completion date, whichever was earlier, or such other period that may be provided by regulation. However, if a study investigated a product that was not yet FDA approved, the FDAAA provided for the delayed posting of study results.