Anne Linker1, Annie Yang2, Nitin Roper3, Evans Whitaker4, Deborah Korenstein5. 1. University of California San Francisco, 631 Diamond Street, San Francisco, CA 94114, USA. Electronic address: Anne.linker@ucsf.edu. 2. Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY 10017, USA. Electronic address: yanga1@mskcc.org. 3. National Institutes of Health/National Cancer Institute, 10 Center Drive, Bethesda, MD 20892, USA. Electronic address: Nitin.roper@nih.gov. 4. Library and Center for Knowledge Management, University of California San Francisco, 530 Parnassus Avenue, San Francisco, CA 94143, USA. Electronic address: Evans.whitaker@ucsf.edu. 5. Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY 10017, USA. Electronic address: korenstd@mskcc.org.
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 randomised 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 end-point; 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 end-point (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.
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 randomised 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 end-point; 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 end-point (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.
Authors: Mohit Bhandari; Jason W Busse; Dianne Jackowski; Victor M Montori; Holger Schünemann; Sheila Sprague; Derek Mears; Emil H Schemitsch; Dianne Heels-Ansdell; P J Devereaux Journal: CMAJ Date: 2004-02-17 Impact factor: 8.262
Authors: Catherine D De Angelis; Jeffrey M Drazen; Frank A Frizelle; Charlotte Haug; John Hoey; Richard Horton; Sheldon Kotzin; Christine Laine; Ana Marusic; A John P M Overbeke; Torben V Schroeder; Harold C Sox; Martin B Van Der Weyden Journal: N Engl J Med Date: 2005-05-23 Impact factor: 91.245
Authors: Michelle K Wilson; Deborah Collyar; Diana T Chingos; Michael Friedlander; Tony W Ho; Katherine Karakasis; Stan Kaye; Mahesh K B Parmar; Matthew R Sydes; Ian F Tannock; Amit M Oza Journal: Lancet Oncol Date: 2014-12-29 Impact factor: 41.316
Authors: Giovanni M Bariani; Anezka C R de Celis Ferrari; Paulo M Hoff; Monika K Krzyzanowska; Rachel P Riechelmann Journal: J Clin Oncol Date: 2013-04-29 Impact factor: 44.544
Authors: Gabriel K Silverman; George F Loewenstein; Britta L Anderson; Peter A Ubel; Stanley Zinberg; Jay Schulkin Journal: J Med Ethics Date: 2010-05 Impact factor: 2.903
Authors: Alessandro Montedori; Maria Isabella Bonacini; Giovanni Casazza; Maria Laura Luchetta; Piergiorgio Duca; Francesco Cozzolino; Iosief Abraha Journal: Trials Date: 2011-02-28 Impact factor: 2.279
Authors: Iosief Abraha; Antonio Cherubini; Francesco Cozzolino; Rita De Florio; Maria Laura Luchetta; Joseph M Rimland; Ilenia Folletti; Mauro Marchesi; Antonella Germani; Massimiliano Orso; Paolo Eusebi; Alessandro Montedori Journal: BMJ Date: 2015-05-27
Authors: Vanessa P Ho; Evelyn I Truong; Saira Nisar; Addison K May; Gregory J Beilman; Donald E Fry; Philip S Barie; Jared M Huston; Jeffrey W Shupp; Fredric M Pieracci Journal: Surg Infect (Larchmt) Date: 2020-05 Impact factor: 2.150
Authors: Fabio Y Moraes; Lucas C Mendez; Neil K Taunk; Srinivas Raman; John H Suh; Luis Souhami; Ben Slotman; Eduardo Weltman; Daniel E Spratt; Alejandro Berlin; Gustavo N Marta Journal: J Neurooncol Date: 2017-11-21 Impact factor: 4.130