E-cigarette manufacturers’ compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs, Inc.
Devito N., Drysdale H., McKee M., Goldacre B.
<p><strong>Background:</strong> Electronic 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 Inc., the largest e-cigarette company in the US against accepted reporting standards.</p> <p><strong>Methods:</strong> We searched ClinicalTrials.gov for all trials sponsored by Juul Labs Inc. and determined those with registry data consistent with coverage by the FDA Amendments Act 2007 (FDAAA). For trials with a primary completion date more than one 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 to registered outcomes in line with CONSORT reporting guidelines.</p> <p><strong>Results:</strong> We located five registered trials sponsored by Juul Labs Inc. 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, just 28 were CONSORT compliant. Specific outcome reporting issues are detailed.</p> <p><strong>Discussion:</strong> 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.</p>