Cited by 63SARS-CoV-2 and COVID-19 ResearchAcademic Publishing and Open AccessVaccine Coverage and Hesitancy

Covid-19 vaccines and treatments: we must have raw data, now

Open access
Doshi, Peter, Godlee, Fiona, Abbasi, Kamran·2022·BMJ

Abstract

Data should be fully and immediately available for public scrutiny

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Crossref · 10.1136/bmj.o102

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Claims the paper makes

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  • These study limitations all stem from the fact that the raw data from COVID-19 vaccine clinical trials are not publicly available.

    “These study limitations all stem from the fact that the raw data from COVID-19 vaccine clinical trials are not publicly available. [45,46].”

    From Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults (2022) · cites this paper as [46]

    The section “Data should be fully and immediately available for public scrutiny” says that participant-level data underlying COVID-19 vaccine trials remain inaccessible to doctors, researchers, and the public. The paper does not establish that all of the citing study’s limitations stem from that lack of access. (LLM, conf=0.86)

    Experimental — accuracy not yet measured
  • As we approach 2 years after release of COVID-19 vaccines, participant-level data remain inaccessible.

    “Unfortunately, as we approach 2 years after release of COVID-19 vaccines, participant level data remain inaccessible. [45,46].”

    From Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults (2022) · cites this paper as [46]

    The 'Data should be fully and immediately available for public scrutiny' section says anonymised participant-level trial data remained inaccessible despite the global vaccine rollout. The paper was published in 2022 and predicts that access may remain restricted for years, but it does not establish the data’s availability at the citing sentence’s nearly two-year mark. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

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Cites

No references could be resolved yet.

Research works printed but not linked: 22

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  4. Doshi P. Neuraminidase inhibitors-the story behind the Cochrane review. BMJ 2009;339:b5164. doi: 10.1136/bmj.b5164 pmid: 19995813 · DOI
  5. Adams B. The pioneers of transparency. BMJ 2015;350:g7717. doi: 10.1136/bmj.g7717 pmid: 25555823 · DOI
  6. The BMJ. Open data campaign. https://www.bmj.com/open-data
  7. Doshi P. From promises to policies: is big pharma delivering on transparency?BMJ 2014;348:g1615. doi: 10.1136/bmj.g1615 pmid: 24574476 · DOI
  8. Loder E, Groves T. The BMJ requires data sharing on request for all trials. BMJ 2015;350:h2373. doi: 10.1136/bmj.h2373 pmid: 25953153 · DOI
  9. Taichman DB, Sahni P, Pinborg A, etal. Data sharing statements for clinical trials. BMJ 2017;357:j2372. doi: 10.1136/bmj.j2372 pmid: 28584025 · DOI
  10. Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342:d2686. doi: 10.1136/bmj.d2686 pmid: 21558364 · DOI
  11. Lexchin J, Herder M, Doshi P. Canada finally opens up data on new drugs and devices. BMJ 2019;365:l1825. doi: 10.1136/bmj.l1825 pmid: 30996020 · DOI
  12. Tanveer S, Rowhani-Farid A, Hong K, Jefferson T, Doshi P. Transparency of COVID-19 vaccine trials: decisions without data. BMJ Evid Based Med 2021:bmjebm-2021-111735. doi: 10.1136/bmjebm-2021-111735 pmid: 34373256 · DOI
  13. Thomas SJ, Moreira ED, JrKitchin N, etalC4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA covid-19 vaccine through 6 months. N Engl J Med 2021;385:1761-73. doi: 10.1056/NEJMoa2110345 pmid: 34525277 · DOI
  14. El Sahly HM, Baden LR, Essink B, etalCOVE Study Group. Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. N Engl J Med 2021;385:1774-85. doi: 10.1056/NEJMoa2113017 pmid: 34551225 · DOI
  15. Voysey M, Clemens SAC, Madhi SA, etalOxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021;397:99-111. doi: 10.1016/S0140-6736(20)32661-1 pmid: 33306989 · DOI
  16. Weinreich DM, Sivapalasingam S, Norton T, etalTrial Investigators. REGEN-COV antibody combination and outcomes in outpatients with covid-19. N Engl J Med 2021;385:e81. doi: 10.1056/NEJMoa2108163 pmid: 34587383 · DOI
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  18. Medicines and Healthcare Products Regulatory Agency. Freedom of Information responses from the MHRA. 2021. https://www.gov.uk/government/collections/freedom-of-information-responses- from-the-mhra-2021 the bmj | BMJ 2022;376:o102 | doi: 10.1136/bmj.o102 2 EDITORIALS on 22 July 2023 by guest. Protected by copyright. http://www.bmj.com/ BMJ: first published as 10.1136/bmj.o102 on 19 January 2022. Downloaded from Mahase E. Covid-19: vaccine advisory committee must be more transparent about decisions, say researchers. BMJ 2021;375:n2452. doi: 10.1136/bmj.n2452 pmid: 34620583 · DOI
  19. Doshi P. Will covid-19 vaccines save lives? Current trials aren't designed to tell us. BMJ 2020;371:m4037. doi: 10.1136/bmj.m4037 pmid: 33087398 · DOI
  20. Iacobucci G. Covid-19: Focus should be on new vaccines rather than boosters, says WHO. BMJ 2022;376:o108doi: 10.1136/bmj.o108. · DOI
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Cited by

Sorted by citations

Authors
Doshi, P., Godlee, F., & Abbasi, K.
Affiliations
BMJ Group (United Kingdom) (GB)
Corresponding author
Doshi, Peter
Venue
BMJ
Publisher
BMJ
Published
2022-01-19
Volume
376
Pages
o102
ISSN
1756-1833 (ISSN-L)
OpenAlex
W4205793382
Cited by
63
References
0
Citations by year
2025: 4 · 2024: 6 · 2023: 26 · 2022: 27
FWCI
7.70
Type
journal article
Language
en
Open access
Locations
  • BMJ (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Moderna
  • Johnson and Johnson
  • Health Canada
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
  • Social Sciences › Health › Vaccine Coverage and Hesitancy
Keywords
COVID-19 vaccines, COVID-19 treatment, raw data availability, data transparency, public scrutiny, clinical trial data, open data
MeSH terms
Public Reporting of Healthcare Data, COVID-19, SARS-CoV-2, COVID-19 Vaccines, COVID-19 Drug Treatment, Humans

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