@DrZweliMkhize
1. Several experts found problematic data in the published phase 1/2 results of Sputnik.
2. Lancet made multiple independent requests for access to the raw dataset, but these were never answered.
thelancet.com/journals/lance…
1. Several experts found problematic data in the published phase 1/2 results of Sputnik.
2. Lancet made multiple independent requests for access to the raw dataset, but these were never answered.
thelancet.com/journals/lance…
3. The concern pertains to the trial protocol.
The Sputnik V investigators mention that three interim analyses were added to the study on Nov 5, 2020,1 but this change was not recorded on ClinicalTrials.gov.
The full study protocol has not been made available.
The Sputnik V investigators mention that three interim analyses were added to the study on Nov 5, 2020,1 but this change was not recorded on ClinicalTrials.gov.
The full study protocol has not been made available.
4. Besides these protocol amendments, the definition of the primary outcome is unclear in the Article.
We lack some crucial information, such as the clinical parameters determining suspected COVID-19, diagnostic protocols were used, when the PCR testing was done&...
We lack some crucial information, such as the clinical parameters determining suspected COVID-19, diagnostic protocols were used, when the PCR testing was done&...
5. concern relates to the data reported and numerical results.
1. vaccinated group on day 20 refer to more individuals than at day 10 (missing info).
2. The number of participants reported for the different vaccinated age cohorts do not add up to the reported total.
1. vaccinated group on day 20 refer to more individuals than at day 10 (missing info).
2. The number of participants reported for the different vaccinated age cohorts do not add up to the reported total.
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