Clinical Trials and “Oversight”

Agreement: 
I Agree
Body: 

Dear Editor
Maryanne Demasi describes the low-key approach to the FDA’s supervision of covid-19 vaccine trials.

The Pfizer trial had in fact 130 research sites in the USA, but still less than 7% of these sites were inspected by the FDA (1).
Worldwide there were 153 sites. Pfizer conducted their own audits (2), but only in 23 sites (15%).
Seven of these audits were described as “non-routine”. These included the sites in Fort Worth (five weeks after Brook Jackson’s complaint to the FDA (3)) and in Argentina, which contributed 13% of the total trial participants and was the only centre to be audited twice by Pfizer.

The requirements for an internal non-routine audit are not specified.
The trial sponsors should have a duty to disclose the outcomes of these audits.

1. Polack FP, Thomas SJ et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine. 2020;383(27):2603-15.
2. https://phmpt.org/wp-content/uploads/2022/04/125742_S1_M5_5351_c4591001-…
3. BMJ 2021;375:n2635

No competing Interests: 
Yes
The following competing Interests: 
Electronic Publication Date: 
Thursday, November 17, 2022 – 12:03
Workflow State: 
Released
Full Title: 

Clinical Trials and “Oversight”

Check this box if you would like your letter to appear anonymously:: 
Last Name: 
Selley
First name and middle initial: 
Peter
Address: 
Crediton, Devon
Occupation: 
Retired GP
BMJ: Additional Article Info: 
Rapid response

Leave a Reply

error: Content is protected !!
Open chat
WhatsApp Now