Study: Researchers Seek Help From FDA To Fill Clinicaltrials.gov Gaps

A report co-sponsored by FDA suggests many clinical trial sponsors want the agency’s help on how to comply with the reporting requirements for HHS’ clinical trials database, Clinicaltrials.gov -- a database suffering from significant gaps and over which FDA has enforcement responsibility. As many as a quarter of the listed studies may not have full results publicly available, a recent study found. FDA announced the report in February. The agency collaborated with the Clinical Trials Transformation Initiative (CTTI) on “the...