Brook Jackson, a trained clinical trial auditor with more than 15 years of experience in clinical research coordination and management, previously worked for Ventavia Research Group of Texas in 2020. After repeatedly alerting her employer of the overwhelming problems in quality control, she decided to file a complaint to the Food and Drug Administration (FDA). She was fired by her employer later the same day.
Jackson provided dozens of internal company documents, photos, audio recordings and emails, with one photo showing "vaccine packaging materials with trial participants' identification numbers written on them left out in the open, potentially "unblinding" participants.
"Blinding" is an important aspect in the integrity of randomized control trials as it safeguards against bias in those conducting the trial, especially when collecting data on participants whose status of receiving the intervention or placebo remains unknown. For instance, research organizations may have financial incentives to produce outcomes favorable to their client and their knowledge of trial participant status may make them biased in how they collect data.
The report also noted that the unblinding may have occurred on a much wider scale as drug assignment confirmation printouts were being left in participant charts, which were accessible to blinded personnel.
The Ventavia management is aware of these issues. In an audio recording of a meeting with Jackson and two other directors, one executive is heard saying that they were not able to quantify the numbers and types of errors they were uncovering with their quality control process.
Additionally, the neglect of the trial subjects experiencing adverse reactions from the injections was an omission that earned the company an email reprimand from ICON, a research organization that partnered with Pfizer on the trial.
In Jackson's email to the FDA, she listed multiple concerns based on her experience with the Pfizer trial, including participants not being monitored by clinical staff, lack of timely follow-ups of patients who experienced adverse events, not reporting protocol deviations, improper storage of vaccines, mislabeled laboratory specimen and targeting staff for reporting problems. (Related: Clinical Drug Trials: FDA Fails to Monitor Safety and Integrity.)
Other documents also indicate significant problems that had been present for many weeks prior to Jackson's arrival at the company, including a list of "action items" distributed among the leadership team, which included names of staff members that she should go over for e-diary issues and falsifying data.
Former colleagues corroborated Jackson's story. One previous executive who was in the recorded meeting apologized to her in June via text, stating that everything she complained about was "spot on."
In Pfizer's briefing document submitted to an FDA advisory committee meeting held in December 2020 to discuss the pharmaceutical giant's application for emergency use authorization of the COVID-19 vaccine, the company did not mention Ventavia in its records.
After the full approval of Pfizer's vaccine in August, the FDA published a summary of its inspections of the trials. Nine of the 153 sites were inspected, none of them from Ventavia. No inspection sites where adults were recruited took place in the eight months after the December 2020 emergency authorization, as well.
An officer from the FDA noted: "The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug]."
Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired the company as a research subcontractor on four other vaccine clinical trials, including a COVID-19 vaccine in children and young adults, pregnant women, a booster dose and a respiratory syncytial virus (RSV) vaccine trial.
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