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Feature BMJ Investigation

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635

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Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

Dear Editor,

It is not a surprise to read the article on data integrity in clinical trials. Most clinical trials have this problem of data collection. People who work at the site level - both from the investigator side and from the sponsor side are overwhelmed with work. From the investigator's side, a person has to look after the practice and the clinical trials. Very few investigators are research oriented and clinical trials bring extra income with little effort. Uploading these into the EMR is not a easy work. For the person working on the sponsor side, visiting many sites to collect data and correct is a humungous task. And checking the data and confirming is herculean task. It is extremely difficult to track patients. Despite digitalisation these problems which are labour intensive will never be solved. The medical personnel from the sponsor side in most of the queries will never get the right answers. Many of the action items will remain unanswered or inconclusive!

While these staff who are working closely with the sites are not looked after - both monetarily and educationally - clinical trials will always suffer data integrity. The importance of the clinical trial should be made understood to these people.

The sponsor is always working with profit as the main concern rather than the safety of patients. It is a rat race for them. Any number of whistleblowers may come but the basic problem is not solved and these kinds of issues will always remain.

regards
mohan

Competing interests: No competing interests

09 November 2021
Mohan Devegowda
GP
solo
mohans clinic 613 2nd main road first stage Indiranagar Bengaluru 560038