The Lancet: Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial; and Authors’ reply…

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The Lancet

Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial

Published:May 12, 2021

Restricted access to data hampers trust in research. Access to data underpinning study findings is imperative to check and confirm the findings claimed. It is even more serious if there are apparent errors and numerical inconsistencies in the statistics and results presented. Regrettably, this seems to be what is happening in the case of the Sputnik V phase 3 trial.1Several experts34 found problematic data in the published phase 1/2 results.2 We have made multiple independent requests for access to the raw dataset, but these were never answered. Despite publicly denying some problems, formal corrections were made to the Article,2 thus addressing some concerns.5 Notwithstanding the previous issues and lack of transparency, the interim results from the phase 3 trial of the Sputnik V vaccine1 again raise serious concerns.

Read the rest here:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00899-0/fulltext

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The Lancet

Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial – Authors’ reply

Published:May 12, 2021

Clear and transparent regulatory standards exist for provision of clinical trial data, including data reported in clinical study reports that are considered sufficient for regulatory review and approvals. The reporting of the interim analysis1 in the phase 3 Sputnik V clinical trial fully complies with those standards. It is on this basis that Sputnik V has received registration in 51 countries, which confirms our full transparency and compliance with regulatory requirements.

The amendment was made to the protocol on Nov 5, 2020. The complete protocol, as amended (Section 10.4 Interim Analysis and Statistical Significance Level Applied), was submitted to The Lancet along with the rest of the documents for review.

View the rest of the article here:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00894-1/fulltext

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