Impact of industry collaboration on randomised controlled trials in oncology

Abstract

Background Industry funders can simply provide money or collaborate in trial design, analysis, or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomized controlled trials (RCT). Methods We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary endpoint; blinding of the patient, clinician, and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. Results We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88–6·83], p<·0001), intention-to-treat analysis (RR 1·32, 95% CI [1·04–1·67], p=·02), and blinding of patients (RR 3·05, 95% CI [1·71–5·44], p<·0001), clinicians (RR 3·36, 95% CI [1·83–6·16], p=<·001), and outcomes assessors (RR 3·03, 95% CI [1·57–5·83], p=·0002). They did not differ in use of overall survival as a primary endpoint (RR 1·27 95% CI [0·72–2·24]) and were similarly likely to report positive results (RR 1·11 95% CI [0·85–1·46], p=0·45). Studies with funding only did not differ from those without funding. Conclusions Oncology RCTs with industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias.

Randomised controlled trials as part of clinical care: A seven‐step routinisation framework proposal

“…Publications on strategies to improve recruitment rates, to retain participants in clinical research, and to facilitate researcher‐clinician collaboration reported difficulties in combining clinical and research roles, where the main reasons were the lack of time, ethical concerns, and absence of leadership, particularly in the field of nursing . The discussed models of combining clinical and research activities in various health fields were collaboration, partnership, and integration . However, the process of routinisation of RCTs in clinical practice has not been discussed as a holistic process and as a separate model, including in the field of wound management.…”

“…33 The discussed models of combining clinical and research activities in various health fields were collaboration, partnership, and integration. [34][35][36][37] However, the process of routinisation of RCTs in clinical practice has not been discussed as a holistic process and as a separate model, including in the field of wound management. In this article, we have developed the Routinisation of Trials Framework, analysing practical suggestions offered by clinical and research nurses from the Australian wound clinics.…”

A Cancer Center and Research Institute at the University of Mississippi Medical Center

“…These can be directly NIH/ NCI funded or pharmaceutically funded as long as the concept originated with the investigator. 4 Taking a compound from discovery, to understanding the mechanism of action, to phase 1 testing is the highlight of a solid experimental therapeutics program. This is a key focus of investment for institutional and philanthropic dollars.…”

Innovation and safety in critical care: should we collaborate with the industry? Pro

“…The subsequent trials methodology must be strong. Some studies report industry collaboration trials were more likely to use high-quality methods than trials without industry funding [3]. Other reports found limited but important differences; industry studies were more likely to be at low risk of bias because of blinding but more likely to yield conclusions that did not align with the results compared with non-industry studies [2].…”

“…Unit, Imperial College Healthcare NHS Trust, St Mary's Hospital, London, UK. 3 Centre for Heart Lung Innovation (HLI), Vancouver, Canada. 4 Division of Critical Care Medicine, St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada.…”