ClinicalTrials.gov published a four-question checklist for sponsors to evaluate whether their study falls under new regulations that mandate the reporting of trial results.
The final rule established by HHS and the National Institutes of Health in September covers interventional studies conducted in the U.S. and for an FDA-regulated product that are not a Phase I or device feasibility studies. The regulations take effect Jan. 18, 2017, and require compliance by April.
Studies must report results even if they fail to reach their endpoints. Penalties include being publicly identified on ClinicalTrials.gov as non-compliant, withholding of grants for federally funded trials, and civil fines of up to $10,000 per day.