Source: https://www.linkedin.com/feed/update/urn%3Ali%3Ashare%3A6862072693689257984
#Covid19: #Whistleblower: #Pfizer’s #vaccine #Data #Integrity issues in #trial : BMJ: The British Medical Journal: #British #Medical #Journal: https://lnkd.in/eKg2tGc9:
Revelations of #poor #practices at a #contract #research #company helping to carry out Pfizer’s pivotal #covid-19 #vaccine #trial raise questions about #data #integrity and #regulatory #oversight. A #regional #director who was employed at the research organisation Ventavia Research Group has told BMJ that the #company #falsified #data, #unblinded #patients, employed #inadequately #trained #vaccinators, and was #slow to #follow #up on #adverse #events reported in Pfizer’s #pivotal #phase III trial. Staff who conducted #quality #control #checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying #Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the #US #Food & #Drug #Administration (#FDA). Ventavia fired her later the same day. Jackson has provided BMJ with dozens of #internal #company #documents, #photos, #audio #recordings, and #emails.
Jackson was a trained #clinical #trial #auditor who previously held a director of operations position and came to Ventavia with more than #15 #years’ #experience in #clinical #research #coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo showed #needles discarded in a #plastic #biohazard #bag instead of a sharps container box. Another showed #vaccine #packaging #materials with #trial #participants’ #identification #numbers written on them left out in the open, potentially #unblinding #participants.
Early and #inadvertent #unblinding may have occurred on a #far #wider #scale. According to the #trial’s #design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that #drug #assignment #confirmation #printouts were being left in #participants’ #charts, #accessible to #blinded #personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, #quality #assurance #checklists were updated with instructions for staff to remove #drug #assignments from charts.
In a recording of a meeting in late Sep. 2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to #quantify the #types and #number of #errors they were finding when examining the #trial paperwork for #quality #control. “In my mind, it’s something new every day… We know that it’s #significant.”
Global Risk Management Network LLC: Silicon Valley-Wall Street-Pentagon-Global Digital CEOs Networks
