New Rules for Clinical Trial Results Disclosure

November 20, 2014 | Regulations proposed yesterday would increase clinical trial transparency. The first would require the results of all clinical trials seeking FDA approval of a drug or therapy to be posted at ClinicalTrials.gov, even trials for drugs that are not approved, and even for phase 1 studies. The second requires any NIH-funded research on interventions to be reported, not just for drugs. The new rules are meant to close disclosure loopholes in the existing regulations, but some caveats still exist. Phase 1 results from privately- or industry-funded trials are excluded, and only summaries of adverse reactions are required. Nature