References
- Siegel JP. Editorial review of protocols for clinical trials. N Eng J Med. 1990;323(19):1355.
- Chan AW, Hróbjartsson A, Haahr MT, et al. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291(20):2457–2465.
- Al-Marzouki S, Roberts I, Evans S, et al. Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet. Lancet (London, England. 2008;372(9634):201. 19
- Chan AW, Hróbjartsson A. Promoting public access to clinical trial protocols: challenges and recommendations. Trials. 2018;19(1):116.
- Zhang S, Liang F, Li W. Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting. J Clin Epidemiol. 2017;91:87–94.
- Perlmutter AS, Tran VT, Dechartres A, et al. Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials. Ann Oncol. 2017;28(4):688–695.
- Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207.
- Pildal J, Chan AW, Hróbjartsson A, et al. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ. 2005;330(7499):1049.
- Ludmir EB, Mainwaring W, Lin TA, et al. Factors associated with age disparities among cancer clinical trial participants. JAMA Oncol. 2019;5(12):1769.
- Wang R, Lagakos SW, Ware JH, et al. Statistics in medicine-reporting of subgroup analyses in clinical trials. N Engl J Med. 2007;357(21):2189–2194.
- Chan AW, Hróbjartsson A, Jørgensen KJ, et al. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ. 2008;337:a2299.
- Dwan K, Altman DG, Cresswell L, et al. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev. 2011;2011(1):Mr000031.
- Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276(8):637–639.
- Clinical Trials Registration and Results Information Submission. 81 Fed. Reg. 183 (Sep 21, 2016) (codified at 42 CFR pt. 11).
- Chan AW, Pello A, Kitchen J, et al. Association of trial registration with reporting of primary outcomes in protocols and publications. JAMA. 2017;318(17):1709–1711.