Study raises concerns about FDA’s poor oversight of clinical trials

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COVID-19 vaccines and drugs were developed at “rapid pace” and now experts are concerned about the US Food and Drug Administration’s (FDA) inadequate oversight of clinical trial sites, a study published by BMJ today.

Regulatory filings show that only nine of 153 Pfizer test sites were subject to FDA review before licensing the COVID-19 mRNA vaccine. Similarly, 10 of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected, investigative reporter Maryanne Demasi writes.

Separately, the FDA received a complaint from whistleblower Brook Jackson, alleging misconduct at three clinical research sites testing the Pfizer COVID-19 vaccine, while she was employed as a regional director. Jackson observed a number of problems, including falsified data, unblinded patients, and inadequately trained vaccinees who were slow to notice side effects. “I thought the FDA was going to swoop in and take care of everything,” Jackson said. However, the FDA did not inspect the testing facilities in question.

Experts have criticized the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which existed before COVID-19, is not limited to a lack of reviews, but also includes a failure to proactively notify the public or scientific journals when violations are identified, effectively keeping scientific misconduct out of the medical establishment.

The FDA is “putting public health at risk” by not being forthcoming about violations that come to light during its review of clinical trials, says David Gortler, a pharmacist and pharmacist who served as the FDA’s medical reviewer from 2007 to 2011 and then as a senior adviser to the FDA. manager in 2019-2021.

The FDA oversees clinical trials of drugs and devices under the FDA in the United States and abroad, if the product is intended for the US market. It conducts routine testing visits, reviews the records of these sites or the Institutional Review Boards (IRBs) overseeing the research at the site, and follows up on complaints of violations. The Food and Drug Administration does not have a target for the percentage of research sites it inspects.

Despite the estimated hundreds of thousands of clinical research sites operating across the United States and abroad, the FDA told The BMJ that it has only 89 inspectors for the Bioresearch Monitoring Program, which ensures the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications. but that it is hiring more inspectors to reach its 100 annual average.

“I don’t think there’s enough staff to do that kind of monitoring,” says Jill Fisher, a professor of social medicine at the University of North Carolina. “The FDA must have enough of a presence to deter research sites from committing fraud,” she continues.

Between March and July 2020, when pandemic restrictions were at their height, the FDA paused its on-site inspections and only “mission critical” inspections were conducted. However, Gortler says this was exactly the time the FDA should have increased its oversight, not decreased, especially as COVID-19 products were being developed at warp speed and aimed at millions of people.

FDA said BMJ it takes oversight of clinical trials seriously and had adapted to travel restrictions, publishing draft guidance on remote monitoring evaluations, which describes live-streamed virtual reviews and video conferencing, and requests to review records remotely.

The FDA has a long history of failing to adequately oversee clinical trial sites, Demasi says. For example, a 2007 report by the U.S. Department of Health and Human Services found that the FDA audited less than 1% of the nation’s clinical trial sites between 2000 and 2005 and was highly critical of the agency for not having a database of functional clinical trial sites.

In response, the FDA said it had established a special task force and “further developed new regulations and guidance to improve the conduct of clinical trials and enhance the protection of people participating in clinical trials,” but declined to interview a member of the clinical trials committee for The BMJ . project management.

Furthermore, the magazine’s 2020 study Science into the FDA’s enforcement of clinical trial regulations between 2008 and 2019 found that the agency was often lax, slow and secretive. It said the FDA rarely imposed sanctions, and when it formally warned researchers for violating the law, it often neglected to ensure the problems were fixed.

Although the FDA publishes its inspection reports, they are not published proactively. It does not typically notify journals when a site participating in a published clinical trial receives a severe warning or alert the public to research misconduct it finds.

Demasi points to reports of understaffing and low morale at the FDA. Fisher says the FDA “needs to be better funded and staffed to conduct inspections. At the very least, the agency needs to inspect sites when complaints or concerns have been raised.”

However, Gortler does not agree that the Food and Drug Administration is underfunded. With a total budget of $6.1 billion by 2021, he notes that the agency needs to be leaner and more efficient, with employees interested in improving public health. “Half of its budget, about $3 billion, is discretionary, which means it could have hired contractors, retired workers or repurposed existing employees. It chose not to. The FDA was just yawning through the pandemic. The whole agency is broken. ”

More information:
Maryanne Demasi et al., Study: FDA Oversight of Clinical Trials ‘Worthfully Inadequate,’ Experts Say, BMJ (2022). DOI: 10.1136/bmj.o2628

Published by the British Medical Journal

Quotation: Study raises concerns over poor FDA oversight of clinical trials (2022, November 16) Retrieved November 16, 2022 from

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