THIS IS WILD—the NIH is expressing “concern” about information released by AstraZeneca on initial #COVID19 vaccine trial data. “AstraZeneca may have included outdated information from trial, which may have provided an incomplete view of the efficacy data”
nih.gov/news-events/ne…
nih.gov/news-events/ne…
2) Yeah, NYT picked up on this NIH statement released just **after midnight** (unusual in itself). nytimes.com/2021/03/22/wor…
3) “Companies sponsoring drug or vaccine trials typically wait for the monitoring board to run analyses and conclude that the study has yielded an answer before they announce trial results....”
4) “In recent days, the monitoring board’s analysis of the AstraZeneca trial was delayed several times because the board had to ask for revised reports from those handling trial data on behalf of the company.”
5) “The monitoring board ultimately conveyed the results of the study to AstraZeneca in a meeting over the weekend, leading to the company’s announcement Monday morning.
6) “Dr. @EricTopol said it was “highly irregular” to see such a public display of friction between a monitoring board and a study sponsor, which are typically in close concordance.
7) “I’ve never seen anything like this,” he said in an interview after the institute’s statement was released. “It’s so, so troubling.”
8) So in my experience with trials, usually the independent DSMB committee conducts the interim analysis without sharing results with company—the company doesn’t control the analysis. So did AZ cherry pick, or did the DSMB fault for outdated data? Unclear.
nytimes.com/2021/03/22/wor…
nytimes.com/2021/03/22/wor…
9) AstraZeneca just denied the claims.
https://twitter.com/DrEricDing/status/1374335591572238337
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