The researchers call on the FDA to strengthen the supervision of clinical trial disclosure, and publish and publish more advance notices of non-compliance

Yale University researchers called on the US FDA to send more advance notices of non-compliance to those who did not report the results of the trial
.
Of the 58 advance notices in the past eight years, 56% were sent to the pharmaceutical industry, and none were sent to federal research agencies

In an opinion article [1] published online in the Journal of the American Medical Association (JAMA) on November 12, 2021, Reshma Ramachandran of Yale University School of Medicine and her colleagues reported that from 2013 to April 2021 On the 29th, the FDA issued 58 advance notices that did not meet the clinical trial reporting requirements
.
Of these, 57 described potentially missing test result information, and 1 described missing registration information

According to the 2007 FDA Amendment (FDAAA), the “responsible party” for applicable clinical trials must register the trial and submit the results to ClinicalTrials.
gov within 12 months after the primary completion date of the trial
.

Ramachandran and co-authors Christopher Morten and Joseph Ross stated that the 57 advance notices issued by the FDA only “represent one of the thousands of clinical trials applicable to FDAAA that were determined to be non-compliant with the result information reporting requirements as of January 2021.
Small part"
.
Morten is a clinical associate professor at Columbia Law School, a Global Health Justice Partnership Fellow at Yale Law School, Ross is a professor of medicine and public health at Yale University School of Medicine, and a member of the Outcome Research and Evaluation Center at Yale-New Haven Hospital

Ramachandran said in an interview, “It’s disappointing to see thousands of trial results without reports
.
” Not knowing the safety and efficacy results “is a problem for us as clinicians trying to prescribe drugs for patients

Ramachandran and the co-authors discovered that the FDA did not send advance notice to any federal agency
.
Of the 57 advance notices, 32 (56%) were sent to the pharmaceutical industry, 1 (2%) was sent to the medical device industry, 18 (32%) were sent to academic institutions, and 6 (11%) were sent to the pharmaceutical industry.

Three non-compliance letters

The first step in FDA enforcement is to send advance notice of non-compliance

What the FDA can do

Yale University researchers listed several steps the FDA can take to strengthen its enforcement actions, starting with issuing more advance notices
.
In addition, they stated that the FDA can use the continuously updated list of reported issues maintained by NIH to quickly identify potential non-compliance issues

The new director may make a difference

Ramachandran believes that the nomination of Robert Califf is a positive sign because he has been focusing on clinical trial reporting issues and said that he is committed to taking steps to improve compliance
.
Califf and Deborah Zarin, the former director of ClinicalTrials.

[1] Ramachandran R, Morten CJ, Ross JS.
Strengthening the FDA's Enforcement of ClinicalTrials.
gov Reporting Requirements.
JAMA.
Published online November 12, 2021.
doi:10.
1001/jama.
2021.
19773

[2] DeVito NJ, Goldacre B.
Evaluation of Compliance With Legal Requirements Under the FDA Amendments Act of 2007 for Timely Registration of Clinical Trials, Data Verification, Delayed Reporting, and Trial Document Submission.
JAMA Intern Med.
2021;181(8) :1128–1130.
doi:10.
1001/jamainternmed.
2021.
2036

[3] Zarin DA, Califf RM.
Trial Reporting and the Clinical Trials Enterprise.
JAMA Intern Med.
2021;181(8):1131–1132.
doi:10.
1001/jamainternmed.
2021.
2041