Objective: Industry has committed to publish results from all Phase 3 clinical trials. We investigated trends in industry-sponsored Phase 3 trials relevant to publication professionals. Research design and methods: This comprehensive, cross-sectional, landscape analysis used data (Oct. 2010-Sep. 2015) exported from www.clinicaltrials.gov. Global rankings (sales by sponsor, therapeutic area, geography) were obtained. Data on trial number, status, type, size, sponsor, therapeutic area, and geography were analyzed by an independent academic statistician. Results: Industry sponsored 53% (n = 5,989) of all Phase 3 trials in the past 5 years. Industry-sponsored open trials increased significantly (2011: n = 124; 2015: n = 846; P50.001). For industry-sponsored open trials (n = 1,964): (a) only 26%involved the top 10 sponsors (Novartis 5%; Roche 4%; AstraZeneca 3%); (b) 79% focused on the top 10 therapeutic areas (oncology 22%; respiratory 10%; infection 10%); (c) trial participation rates were: US 51%; Europe 44%; Japan 12%; Brazil, Russia, India, China [BRIC] 39%; (d) 82% were randomized; and (e) the mean recruitment target was 572. Results posting was significantly worse for nonindustry-sponsored trials (completed 12 months, no results: non-industrysponsored, n = 1,367/1,466, 93%; industry-sponsored, n = 1,642/2,540, n = 65%; P50.001; terminated 12 months, no results: non-industrysponsored, n = 136/147, 93%; industry-sponsored, n = 202/278, 73%; P50.001). Conclusions: Trial analysis provides quantitative insights relevant to publication professionals. For industry trials, publishing workload will intensify and be spread across many sponsors. Demand should be high for industry and agency professionals with expertise in reporting randomized trials in the top therapeutic areas identified and with a proven ability to work with large datasets and international authors. Industry and (especially) non-industry sponsors must allocate resources to report a backlog of completed and terminated trials.
12th Annual Meeting of International Society for Medical Publication Professionals (ISMPP), National Harbour, United States 11-13 April 2016
Current Medical Research and Opinion / Vol. 32, Supplement 1, pp.S9