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EBM analysis
General medicine
Transparency of COVID-19 vaccine trials: decisions without data
  1. Sarah Tanveer1,
  2. Anisa Rowhani-Farid1,
  3. Kyungwan Hong1,
  4. Tom Jefferson2,
  5. Peter Doshi1
  1. 1 Department of Pharmaceutical Health Services Research, University of Maryland Baltimore, Baltimore, Maryland, USA
  2. 2 Department for Continuing Education, University of Oxford, Oxford, UK
  1. Correspondence to Dr Peter Doshi, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA; pdoshi{at}rx.umaryland.edu

https://doi.org/10.1136/bmjebm-2021-111735

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    Summary box

    • Data transparency has become a well-established norm in biomedical research, and is especially important for broadly used public health interventions like COVID-19 vaccines.

    • Tax payers helped fund COVID-19 vaccine trials and should have the right to access the results.

    • There is inadequate availability of COVID-19 vaccine trial documents and data; individual participant data will not be available for months, perhaps years, for most vaccines.

    • Widespread use of interventions without full data transparency raises concerns over the rational use of COVID-19 vaccines.

    • Trial transparency must start early and be continuous. Trial protocols should be released once finalised, before trial results are reported, and should be accompanied with the release of trial documents and data before clinicians and the public make decisions regarding product use.

    Transparency in clinical trials: an established norm across sectors

    Access to data for drugs and vaccines has historically been fairly limited to journal article publications and hard-to-access and difficult to read regulatory reports.1 But the past decade has witnessed strides in clinical trial data transparency. A wide range of institutions, from pharmaceutical companies, government agencies, trade organisations, journals and not-for-profit organisations, have all acknowledged the importance of data sharing, including the release of deidentified individual participant data. Many policies, regulations and platforms now exist to facilitate data access, including landmark transparency policies from the European Medicines Agency (EMA)2 3 and Health Canada.4 Both regulators now post on their websites, sections of the licensure dossier received by the industry (https://clinicaldata.ema.europa.eu/ and https://clinical-information.canada.ca/). There are also industry and academic platforms to facilitate third-party access to trial data and documents, including ClinicalStudyDataRequest.com, Yale University Open Data Access (YODA) Project and Vivli.5 In 2013, the US and European industry trade organisations endorsed a joint statement on clinical trial data sharing, making a series of commitments that ‘recognise the importance of sharing clinical trial data in the …

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    Footnotes

    • Twitter @AnisaFarid, @RIATinitiative

    • Contributors ST and PD conceptualised the article and ST wrote the first draft. AR-F and KH led the data extraction and analysis. All authors (ST, AR-F, KH, TJ, PD) were involved in reviewing and editing the final manuscript.

    • Funding The Laura and John Arnold Foundation funds the RIAT Support Center, which supports the salaries of ST, AR-F, KH, TJ and PD.

    • Disclaimer The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS, The University of Maryland, or the US Government.

    • Competing interests KH was supported by the Food and Drug Administration (FDA) of the US Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946, unrelated to this manuscript, totaling US$5000 with 100% funded by FDA/HHS. PD has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018); grants from the FDA (through University of Maryland M-CERSI; 2020), Laura and John Arnold Foundation (2017–2022), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014–2016), Cochrane Methods Innovations Fund (2016-2018) and UK National Institute for Health Research (2011–2014); was an unpaid IMEDS steering committee member at the Reagan-Udall Foundation for the FDA (2016–2020), and is an editor at The BMJ. The Laura and John Arnold Foundation funds the RIAT Support Center, which supports the salaries of ST, ARF, KH, TJ, and PD. TJ’s competing interests are online (https://restoringtrials.org/competing-interests-tom-jefferson/).

    • Provenance and peer review Commissioned; externally peer reviewed.