FDA Oversight of Clinical Trials is “Grossly Inadequate” Say Experts

Maryanne Demasi

On 25 September 2020, the US Food and Drug Administration (FDA) received a complaint by Brook Jackson who had been working for Ventavia Research Group, a Texas based company hired to run clinical trials for Pfizer’s covid-19 mRNA vaccine. Jackson, a regional director, had witnessed problems at three trial sites she was overseeing and complained to an FDA inspector about a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events.

… This lack of oversight was not an isolated case, The BMJ has learnt. Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection before licensing the mRNA vaccine. Similarly, only 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected.

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