FDA pushes sponsors to report missing trial results
The agency contacted more than 2,200 companies and researchers tied to more than 3,000 registered clinical trials that may be missing required results submissions.
The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers to submit required clinical trial results information to ClinicalTrials.gov.
Messages were sent March 30 in connection with more than 3,000 registered clinical trials. FDA said the trials either do not appear to have submitted required results information or may not have completed the National Library of Medicine’s quality-control review process.
An internal FDA analysis found that 29.6% of studies highly likely to fall under mandatory reporting requirements had no results information submitted to ClinicalTrials.gov.
Mandatory reporting generally applies to interventional studies with a U.S. nexus and an FDA-regulated product that are past the results-reporting deadline. Phase 1 studies and device feasibility studies are excluded from the set described by FDA.
Certain sponsors and researchers must submit clinical trial results information to ClinicalTrials.gov 1 year after trial completion. FDA said missing negative trial results can create publication bias and distort the public record on medical product safety and efficacy.
“Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers,” FDA Commissioner Marty Makary, MD, MPH, said in the announcement.
The March 30 messages seek voluntary compliance. FDA said it may also issue pre-notices of noncompliance and notices of noncompliance as part of risk-based compliance efforts.
Sources
- FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results. Government document
About the author
RadiologySignal.com writersEditorial Team
Radiology Signal Staff covers developments across medical imaging, radiology AI, imaging informatics, clinical research, and radiology business. The team monitors primary sources, peer-reviewed studies, company announcements, society updates, and healthcare industry news to deliver concise reporting for imaging professionals.
More from this section
Lumexa Imaging reports vendor-related data incident
A vendor incident may have exposed patient identifiers, insurance information, diagnoses, visit dates, and other radiology-related health information tied to Lumexa-affiliated practices.
MOC-linked radiation oncology care associated with lower Medicare costs
A retrospective Medicare Part B analysis found that radiation oncologists voluntarily participating in ABR maintenance of certification used more advanced techniques and had 10.31% lower Medicare costs per treatment course.
Senators reintroduce MARCA radiologist assistant reimbursement bill
The Medicare Access to Radiology Care Act would allow radiologists to submit Medicare claims for nondiagnostic services performed by radiologist assistants under direct supervision in hospital and office settings.