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Original research
E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs
  1. Nicholas J DeVito1,
  2. Henry Drysdale1,
  3. Martin McKee2,
  4. Ben Goldacre1
  1. 1 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  2. 2 Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK
  1. Correspondence to Nicholas J DeVito, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK; nicholas.devito{at}phc.ox.ac.uk

Abstract

Background Electronic cigarettes (e-cigarettes) are a frequently debated topic in public health. It is essential that clinical trials examining e-cigarettes are fully and accurately reported, especially given long-standing concerns about tobacco industry research. We assess the reporting of clinical trials sponsored by Juul Labs, the largest e-cigarette company in the USA, against accepted reporting standards.

Methods We searched ClinicalTrials.gov for all trials sponsored by Juul Labs and determined those with registry data consistent with coverage by the Food and Drug Administration (FDA) Amendments Act 2007 (FDAAA). For trials with a primary completion date more than 1 year earlier, we searched ClinicalTrials.gov, the academic literature and a Juul-funded research database (JLI Science) for results. For located results, we compared reported outcomes with registered outcomes in line with Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines.

Results We located five registered trials sponsored by Juul Labs that appeared covered by the FDAAA 2007 in the public data. All five trials did not have results available on ClinicalTrials.gov. We found one publication and four poster presentations reporting results for four of the five covered trials outside of ClinicalTrials.gov. Of 61 specified outcomes, 28 were CONSORT compliant. Specific outcome reporting issues are detailed.

Discussion Our findings raise substantial concerns regarding these trials. Clinicians, public health professionals, and the public cannot make informed choices about the benefits or hazards of e-cigarettes if the results of clinical trials are not completely and transparently reported. Clarification and potential enforcement of reporting laws may be required.

  • electronic nicotine delivery devices
  • public policy
  • tobacco industry

Data availability statement

The dataset for this study, including detailed outcome assessments, are available via FigShare (DOI: 10.6084/m9.figshare.14627346). Detailed assessments are also included as online supplementary material.

https://doi.org/10.1136/tobaccocontrol-2020-056221

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    Data availability statement

    The dataset for this study, including detailed outcome assessments, are available via FigShare (DOI: 10.6084/m9.figshare.14627346). Detailed assessments are also included as online supplementary material.

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    Footnotes

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    • Contributors NJD conceived the study, analysed the data and wrote the first draft of the manuscript. NJD and HD collected the data. BG supervised the work. All authors gave input on the analysis, interpretation and critical revision to the final manuscript.

    • Funding Work on the TrialsTracker Project is currently funded through a grant from the Good Thinking Society and has previously been funded by a grant from the Laura and John Arnold Foundation. NJD’s doctoral work is funded by a studentship from the Naji Foundation.

    • Disclaimer The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.

    • Competing interests The authors declare no direct conflicts of interest related to this work. BG has received research funding from the Laura and John Arnold Foundation, The Good Thinking Society, Wellcome Trust, the NHS National Institute for Health Research, the NHS National Institute for Health Research School of Primary Care Research, the Oxford Biomedical Research Centre, the Mohn-Westlake Foundation, the Health Foundation, and the WHO; he also receives personal income from speaking and writing for lay audiences on the misuse of science and is a co-founder of the AllTrials Campaign. NJD and HD report employment on grants obtained by BG. NJD separately reports doctoral funding from the Naji Foundation and a grant from the Fetzer Franklin Fund.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.