Covid-19: Researcher Slams Data Integrity Issues in Pfizer Vaccine Trial

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Covid-19: Researcher Slams Data Integrity Issues in Pfizer Vaccine Trial
Covid-19: Researcher Slams Data Integrity Issues in Pfizer Vaccine Trial
For researchers testing Pfizer's vaccine at multiple sites in Texas this fall, speed may have come at the cost of data integrity and patient safety.

A regional director employed by research organization Ventavia Research Group told the BMJ that the company falsified data, unblinded patients, employed insufficiently trained vaccinators and was slow to respond to adverse events reported in Pfizer's pivotal phase III trial.
Staff performing quality checks were overwhelmed by the volume of issues detected.

After informing Ventavia of these problems several times, regional manager Brook Jackson sent an email complaint to the U.S. Food and Drug Administration (FDA).

Jackson provided the BMJ with dozens of internal company documents, photos, audio recordings and emails.

Read the full survey:
Covid-19: Researcher Slams Data Integrity Issues in Pfizer Vaccine Trial
https://www.bmj.com/content/375/bmj.n2635

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