Associations between industry involvement and study characteristics at the time of trial registration in biomedical research

Anna Lene Seidler; Kylie E Hunter; Nicholas Chartres; Lisa M Askie

doi:10.1371/journal.pone.0222117

Associations between industry involvement and study characteristics at the time of trial registration in biomedical research

PLoS One. 2019 Sep 25;14(9):e0222117. doi: 10.1371/journal.pone.0222117. eCollection 2019.

Authors

Anna Lene Seidler¹, Kylie E Hunter¹, Nicholas Chartres², Lisa M Askie¹

Affiliations

¹ NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
² The University of Sydney, Sydney, Australia.

Abstract

Background: Commercial or industry funding is associated with outcomes that favour the study funder in published studies, across various areas of research. However, it is currently unclear whether there are differences between trials with and without industry involvement at the stage of trial registration.

Objective: To determine whether industry involvement (industry sponsorship, funding, or collaboration) is associated with trial characteristics at the time of trial registration.

Methods: We conducted a cross-sectional analysis of all interventional studies registered on the Australian New Zealand Clinical Trials Registry in 2017 and classified them by industry involvement. We analysed whether there were differences in study characteristics (including type of control, sample size, study phase, randomisation, registration timing, and purpose of study) by industry involvement.

Results: Industry involvement was reported by 21% of the 1,433 included trials. Only 40% of trials with industry involvement used an active control compared to 58% of non-industry trials (OR = 0.49, 95%CI = 0.38 to 0.63, p < .001), and industry trials reported smaller sample sizes (Median(IQR)industry = 45(24-100), Median(IQR)non-industry = 70(35-160), Mean Difference = -153, 95% CI = -233 to -75, p < .001). Industry trials were more likely to be earlier phase trials (Χ2(df) = 71.46(4), p < .001). There was no difference in use of randomisation between industry (70%) and non-industry trials (73%) (OR = 0.88, 95%CI = 0.67-1.20, p = .38). Eighty-three percent of industry trials compared to 70% of non-industry trials were prospectively registered (OR = 2.02, 95%CI = 1.47-2.82, p < .001). Industry trials were more likely to assess treatment (85%), rather than prevention, education or diagnosis compared to non-industry trials (64%) (OR = 3.02, 95%CI = 2.17-4.32, p < .001).

Conclusion: The current study gives insight into differences in trial characteristics by industry involvement at registration stage. There was a reduced use of active controls in trials with industry involvement which has previously been proposed as a mechanism behind more favourable results. Non-industry funders and sponsors are crucial to ensure research addresses not only treatments, but also prevention, diagnosis and education questions.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biomedical Research
Clinical Trials as Topic / economics
Clinical Trials as Topic / methods*
Clinical Trials as Topic / statistics & numerical data
Cross-Sectional Studies
Drug Industry / economics
Financial Management / statistics & numerical data
Humans
Industry* / economics
New Zealand
Registries / statistics & numerical data

Grants and funding

ANZCTR is supported by funding from the Australian Federal Government, Health Research Council of New Zealand and Department of Health and Therapeutic Innovation Australia (TIA). TIA is supported by the Australian Government through the National Collaborative Research Infrastructure Strategy (NCRIS) program. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.