Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial
The presented primary result (efficacy of 91·6%) is dependent on this change, but the reasons for the change have not been made public. [...]the latest ClinicalTrials.gov record (Jan 22, 2021) defines the primary outcome inconsistently: “Primary Outcome Measures: percentage of trial subjects…after t...
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| Veröffentlicht in: | The Lancet (British edition) 2021-05, Vol.397 (10288), p.1881-1883 |
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| container_issue | 10288 |
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| container_title | The Lancet (British edition) |
| container_volume | 397 |
| creator | Bucci, Enrico M Berkhof, Johannes Gillibert, André Gopalakrishna, Gowri Calogero, Raffaele A Bouter, Lex M Andreev, Konstantin Naudet, Florian Vlassov, Vasiliy |
| description | The presented primary result (efficacy of 91·6%) is dependent on this change, but the reasons for the change have not been made public. [...]the latest ClinicalTrials.gov record (Jan 22, 2021) defines the primary outcome inconsistently: “Primary Outcome Measures: percentage of trial subjects…after the first dose…based on the percentage…after the second dose”. Besides these protocol amendments, the definition of the primary outcome is unclear in the Article,1 where it says that when COVID-19 was suspected, participants were assessed with “COVID-19 diagnostic protocols, including PCR testing”. [...]there is no information about what caused the exclusion of 13 986 participants, as per the trial profile. |
| doi_str_mv | 10.1016/S0140-6736(21)00899-0 |
| format | Article |
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| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2021-05, Vol.397 (10288), p.1881-1883 |
| issn | 0140-6736 1474-547X |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals Complete; ProQuest Central UK/Ireland |
| subjects | Age groups Coronaviruses Correspondence COVID-19 COVID-19 vaccines Humans Research Report |
| title | Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial |
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