Drugs

FDA Urges Trial Sponsors to Disclose Missing Clinical Study Results

FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requirements to publicly report study results on ClinicalTrials.gov, amid concerns about widespread underreporting and potential bias in the scientific record. The agency said the outreach, conducted 3/30, targeted organizations linked to more than 3,000 registered trials that appear to be missing required results data or have not completed the National Library of Medicine’s quality review process.

FDA officials warned that failure to disclose results — particularly negative findings — creates significant gaps in publicly available evidence and can distort perceptions of a medical product’s safety and effectiveness.

An internal FDA analysis found that 29.6% of trials likely subject to mandatory reporting requirements have not submitted results. These requirements generally apply to certain interventional studies involving FDA-regulated products, excluding early-stage Phase 1 and device feasibility trials.

“Far too often, companies are suppressing unfavorable clinical trial results,” FDA commissioner Marty Makary is quoted in a release as saying. “Those sponsoring clinical trials have an ethical obligation to make results public regardless of the data’s influence on the company’s share price.”

Makary added that incomplete reporting leaves clinicians without critical information needed to make informed treatment decisions.

Under federal law, sponsors are required to submit results information to ClinicalTrials.gov within one year of trial completion. FDA said the recent notifications are intended to encourage voluntary compliance before the agency escalates enforcement.

The agency said it retains the authority to issue Pre-Notices and Notices of Noncompliance as part of its risk-based enforcement approach, but characterized the latest action as an “extra step” to prompt corrective action.

FDA and NIH have been repeatedly criticized for being too lax in enforcing ClinicalTrials.gov reporting rules. In past notices to alleged violators of the reporting mandate, FDA noted it may seek civil monetary penalties against organizations, which can reach up to $10,000 per day for continued noncompliance. To date, civil money penalties have not been sought.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome