Friday, March 29, 2024
HomeHealth & FitnessDrugsFDA Oversight of Clinical Trials Described as 'Grossly Inadequate'

FDA Oversight of Clinical Trials Described as ‘Grossly Inadequate’

Date:

Related stories

iPhone 12 gets 15W Qi2 wireless charging support with iOS 17.4

Apple released iOS 17.4 earlier this month, and...

A Comprehensive On-Page SEO Checklist for 2024

If you’ve invested time and effort writing an...

Throwing A Snowball Can Crash The Game

Helldivers 2 is a very good third-person online...

What Cute Things Have You Enjoyed Lately?

This week, I was walking down the street...
spot_imgspot_img


By Elana Gotkine HealthDay Reporter>

THURSDAY, Nov. 17, 2022 — The U.S. Food and Drug Administration oversight of clinical trials has been described by experts as “grossly inadequate,” according to an article published online Nov. 16 in The BMJ.

Following complaints to the FDA relating to problems at three Pfizer COVID-19 vaccine clinical sites reported by an overseer, including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events, Maryanne Demasi, an investigative journalist based in Sydney, describes inadequate oversight in relation to development of the COVID-19 vaccine and predating the pandemic.

Regulatory documents showed that before licensing the mRNA vaccine, only nine of 153 Pfizer trial sites were subject to FDA inspection; similarly, inspections were carried out on only 10 of 99 Moderna trial sites and five of 73 remdesivir trial sites. At the peak of the pandemic restrictions, the FDA paused site inspections, instead of ramping up oversight since COVID-19 products were being developed rapidly. The FDA has a history of failing to oversee clinical sites adequately, with a 2007 report noting that the FDA audited less than 1 percent of the nation’s clinical trials sites between 2000 and 2005. In response to this report, a dedicated task force was established, although the request for an interview with a task force member was denied. Despite the estimated hundreds of thousands of clinical trial sites in operation, the FDA only has 89 inspectors who assure the quality and integrity of data submitted in support of new product approvals and marketing applications. Although inspection reports are published, the database is not comprehensive and reports are not disclosed proactively, according to Demasi.

“The FDA was just yawning its way through the pandemic. The entire agency is broken,” David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011, said in a statement.

“The FDA takes its oversight of clinical trials very seriously and continued conducting in-person inspections in the U.S. and abroad throughout the ongoing pandemic,” FDA press officer Abby Capobianco told DailyMail.com. “We prioritized inspections for COVID-related products, including vaccines, ensuring FDA-regulated COVID-19 products are able to be used to save American lives.”

Abstract/Full Text

© 2022 HealthDay. All rights reserved.



Source link

Latest stories

spot_img