HHS, NIH want to expand ClinicalTrials.gov mandates

HHS and NIH on Wednesday proposed new rules governing the transparency of clinical trials that could more than double the number of submissions of study results to ClinicalTrials.gov.

The agencies issued a notice of proposed rulemaking that would require sponsors to report summary results from all trials regardless of whether the compound or device has been approved. Currently, sponsors need only report data from trials of approved drugs and devices. ...