FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

Sept. 27, 2021 – In the midst of public scrutiny regarding clinical trial transparency, the Food and Drug Administration (FDA) and the United Kingdom’s Health Research Agency (HRA) recently took actions that may indicate their increased willingness to more closely monitor clinical investigators who do not report trial results in a timely manner.

“Pharma, researchers, and medical communications firms should take note of these actions,” said Coalition for Healthcare Communication Exeutive Director Jon Bigelow. “Pharma trials are often multi-national and it appears that regulatory agencies in the United States and the U.K. may be taking a closer look at how they enforce their reporting requirements and possibly impose fines for noncompliance on sponsors and principal investigators.”

The FDA sent a “notice of noncompliance” to clinical trial investigator Dr. Andrey Petrikovets on Aug. 31, 2021, as part of an ongoing request that he submit trial results to in a timely manner. Under FDA requirements, a responsible party for any clinical investigation must submit those results “no later than one year after the primary completion date of the applicable clinical trial, unless the responsible party has submitted a certification of delay, a request for an extension of good cause, or a request for a waiver of the requirements for submission of results information,” the FDA states.

The FDA had previously sent a similar letter to Petrikovets In July 2020, asking him to submit trial results for a clinical trial comparing “ICE-T Postoperative Multimodal Pain Regimen” to the standard regimen in same-day vaginal pelvic reconstructive surgery. Petrikovets responded to that letter in July 2020 by including a manuscript including published results of the trial. The FDA deemed that response insufficient to meet the requirements in a September 2020 letter back to him. Petrikovets answered that letter in November 2020, stating that he was busy with the COVID-19 surge and was short-staffed.

“Although we recognize the unique circumstances that the pandemic presents, we believe we have provided you ample opportunity to submit the required results information,” the FDA’s Aug. 31 letter states. The agency also points out that a failure to submit the clinical trial results to is a “prohibitive act” that is subject to a civil monetary penalty (CMP) of not more than $10,000 for each day of the violation until the violation is corrected. Petrikovets submitted his results on Sept. 1 (one day after the FDA letter was sent).

Although no CMP was imposed in this case, a Sept. 9 article in STAT cites data from a U.K.-based website, the FDAAA TrialsTracker, which states that although the FDA could have imposed CMPs of more than $23 billion for the 26 percent of trials that have not been reported, to date it has collected none.

The HRA is in a similar boat in enforcing the U.K. requirement that clinical trial results be reported within a year of completion. On Sept. 15, it announced a clinical trials tracking system that it says “is in line with the commitments set out in its Make it Public research transparency strategy.”

Under the new system, which applies to all interventional trials involving  U.K. patients (including international trials with a study arm in the U.K.), “a key responsibility is that researchers plan at the outset of their study how they will communicate the results to participants at the end of the study,” according to the HRA. “The new reporting requirement will help the HRA check that this has been done.”

“We  know that most researchers want to be transparent and just need help to do that,” HRA Director of Policy and Partnership Juliet Tizzard said in a prepared statement.