Compliance with reporting clinical trial results varies across research fields and types of sponsors. In rheumatology, most industry-funded trials of biologic agents are currently reported promptly. Optimizing clinical research will nevertheless require steps beyond deposition of summary results, including making raw data and protocols available, and assuring independence of the research agenda.
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US Food and Drug Administration. Food and Drug Administration Amendments Act of 2007. Public Law 110–85 [online], (2007).
Anderson, M. L. et al. Compliance with results reporting at ClinicalTrials.gov. N. Engl. J. Med. 372, 1031–1039 (2015).
Prayle, A. P., Hurley, M. N. & Smyth, A. R. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 344, d7373 (2012).
Law, M. R., Kawasumi, Y. & Morgan, S. G. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. Health Aff. (Millwood) 30, 2338–2345 (2011).
Saito, H. & Gill, C. J. How frequently do the results from completed US clinical trials enter the public domain?—A statistical analysis of the ClinicalTrials.gov database. PLoS ONE 9, e101826 (2014).
Ioannidis, J. P. & Karassa, F. B. The need to consider the wider agenda in systematic reviews and meta-analyses: breadth, timing, and depth of the evidence. BMJ 341, c4875 (2010).
Ioannidis, J. P., Karassa, F. B., Druyts, E., Thorlund, K. & Mills, E. J. Biologic agents in rheumatology: unmet issues after 200 trials and $200 billion sales. Nat. Rev. Rheumatol. 9, 665–673 (2013).
Khan, N. A., Lombeida, J. I., Singh, M., Spencer, H. J. & Torralba, K. D. Association of industry funding with the outcome and quality of randomized controlled trials of drug therapy for rheumatoid arthritis. Arthritis Rheum. 64, 2059–2067 (2012).
Goodman, S. N. Clinical trial data sharing: what do we do now? Ann. Intern. Med. 162, 308–309 (2015).
Flacco, M. E. et al. Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor. J. Clin. Epidemiol. http://dx.doi.org/10.1016/j.jclinepi.2014.12.016 (2015).
The authors declare no competing financial interests.
Update as of 27 March 2015 on RCTs of anti-TNF agents in immune-mediated diseases that were registered by January 20, 2013 in ClinicalTrials.gov but had not been published by that time.* (DOCX 34 kb)
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