- The U.S. Food and Drug Administration (FDA) cites Acceleron Pharma Inc. for failure to submit clinical trial results data to ClinicalTrials.gov within one year after the clinical trial’s primary completion date.
- The Notice of Noncompliance follows on the heels of FDA’s August 2020 guidance on its authority to seek civil monetary penalties related to ClinicalTrials.gov compliance.
- Studies suggest a widespread lack of compliance with the ClinicalTrials.gov reporting requirements, likely resulting from the FDA’s lack of enforcement.
- Sponsors should take this citation as a sign of future enforcement and audit their procedures to ensure they are compliant with reporting requirements on a go-forward basis.
- Institutions should determine whether their clinical trial agreements with sponsors require the sponsors to comply with ClinicalTrials.gov reporting requirements. Some institutions may mandate that the sponsor comply with these reporting requirements and that the institution’s principal investigators are not responsible for this reporting.
Since 2007, sponsors and certain principal investigators must submit clinical trial registration and results data to ClinicalTrials.gov. The reporting requirement resulted from public and regulator concerns of lack of transparency of clinical trial results and was imposed to make clinical trial information more widely available to the public. Despite the longstanding nature of this requirement, on April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to Acceleron Pharma Inc., for failure to submit required results data to ClinicalTrials.gov. The citation relates to Acceleron’s study, “A Phase 2 Randomized, Double-Blind Study of Dalantercept and Axitinib Compared to Placebo and Axitinib with Advanced Renal Cell Carcinoma.” The clinical trial was completed in June 2017, but as of the citation date, Acceleron had not submitted the final results data that were due one year after the trial’s primary completion date.
The reporting requirements are set forth in Section 801 of the Food and Drug Administration Amendments Act of 2007, known as FDAAA 801 and codified at Section 402(j) of the Public Health Services Act. The Acts require a “responsible party” for a clinical trial to register the trial and submit results data to ClinicalTrials.gov. Responsible parties are typically sponsors of clinical trials, but they can also be principal investigators of clinical trials if designated by the sponsor and if the principal investigators are responsible for conducting the trial, have access to and control over the data from the trial, and meet all the requirements of submission of the trial information.
Recent industry studies suggest a widespread lack of compliance with the ClinicalTrials.gov reporting requirements, which likely results from the fact that the FDA has done little to enforce the requirements. Sponsors, including physicians conducting investigator-initiated research where the physician-investigator is acting as the trial sponsor, should take the FDA’s citation against Acceleron Pharma Inc. as a sign of future enforcement and audit their compliance and procedures to ensure compliance on a go-forward basis. To the extent sponsors delegate the reporting requirements to principal investigators, sponsors should likewise audit the principal investigators’ reporting compliance and ensure they have proper agreements in place that protect the sponsors in the event the principal investigators fail to report.
Institutions, on the other hand, should determine whether their clinical trial agreements require sponsors to comply with ClinicalTrials.gov reporting requirements. Some institutions may choose to require sponsors to represent and warrant in their clinical trial agreements that the study will be registered on ClinicalTrials.gov, and that the sponsor will comply with all applicable reporting requirements. Further, institutions may wish to clarify in their clinical trial agreements that the reporting obligations are the sponsor’s and not the principal investigator’s.
Finally, physician practices conducting clinical research should also review whether their clinical trial agreements require sponsors to comply with the reporting requirements. Physicians acting as sponsors for any investigator-initiated research should ensure compliance with all registration and clinical trial reporting requirements, given FDA’s renewed enforcement focus.
McGuireWoods’ clinical trial team helps sponsors and institutions ensure compliance with regulatory requirements and draft and negotiate clinical trial agreements worldwide. Contact the authors of this alert for more information on bringing contracting best practices to your clinical trials.