Access to unpublished protocols and statistical analysis plans of randomised trials

Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005;330(7494):753.

Article  Google Scholar 

Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004;291(20):2457–65.

CAS  Article  Google Scholar 

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.

Article  Google Scholar 

Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.

Article  Google Scholar 

Chen T, Li C, Qin R, Wang Y, Yu D, Dodd J, et al. Comparison of clinical trial changes in primary outcome and reported intervention effect size between trial registration and publication. JAMA Netw Open. 2019;2(7):e197242-e.

Article  Google Scholar 

Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008;3(8):e3081.

Article  Google Scholar 

Goldacre B, Drysdale H, Dale A, Milosevic I, Slade E, Hartley P, et al. COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time. Trials. 2019;20(1):118.

Article  Google Scholar 

Hahn S, Williamson PR, Hutton JL. Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee. J Eval Clin Pract. 2002;8(3):353–9.

CAS  Article  Google Scholar 

Li G, Abbade LPF, Nwosu I, Jin Y, Leenus A, Maaz M, et al. A systematic review of comparisons between protocols or registrations and full reports in primary biomedical research. BMC Med Res Methodol. 2018;18(1):9.

Article  Google Scholar 

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63(8):e1–37.

Article  Google Scholar 

Ramagopalan S, Skingsley AP, Handunnetthi L, Klingel M, Magnus D, Pakpoor J, et al. Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study. F1000Res. 2014;3:77.

Article  Google Scholar 

Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med. 2008;5(11):e217 discussion e.

Article  Google Scholar 

Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.

Article  Google Scholar 

Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med. 2009;361(20):1963–71.

CAS  Article  Google Scholar 

Williamson PR, Gamble C, Altman DG, Hutton JL. Outcome selection bias in meta-analysis. Stat Methods Med Res. 2005;14(5):515–24.

CAS  Article  Google Scholar 

Babu C, Mell L, Lee N, Zakeri K. Public access to protocols of contemporary cancer randomized clinical trials. Trials. 2021;22(1):418.

Article  Google Scholar 

Chan AW, Hrobjartsson A, Jorgensen KJ, Gotzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ. 2008;337:a2299.

Article  Google Scholar 

Cro S, Forbes G, Johnson NA, Kahan BC. Evidence of unexplained discrepancies between planned and conducted statistical analyses: a review of randomised trials. BMC Med. 2020;18(1):137.

Article  Google Scholar 

Dwan K, Altman DG, Clarke M, Gamble C, Higgins JP, Sterne JA, et al. Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials. PLoS Med. 2014;11(6):e1001666.

Article  Google Scholar 

Greenberg L, Jairath V, Pearse R, Kahan BC. Pre-specification of statistical analysis approaches in published clinical trial protocols was inadequate. J Clin Epidemiol. 2018;101:53–60.

Article  Google Scholar 

Kahan BC, Ahmad T, Forbes G, Cro S. Public availability and adherence to pre-specified statistical analysis approaches was low in published randomised trials. J Clin Epidemiol. 2020;128:29–34.

Article  Google Scholar 

Kahan BC, Forbes G, Cro S. How to design a pre-specified statistical analysis approach to limit p-hacking in clinical trials: the pre-SPEC framework. BMC Med. 2020;18(1):253.

Article  Google Scholar 

Page MJ, McKenzie JE, Forbes A. Many scenarios exist for selective inclusion and reporting of results in randomized trials and systematic reviews. J Clin Epidemiol. 2013;66(5):524–37.

Article  Google Scholar 

Spence O, Hong K, Onwuchekwa Uba R, Doshi P. Availability of study protocols for randomized trials published in high-impact medical journals: a cross-sectional analysis. Clin Trials. 2020;17(1):99–105.

Article  Google Scholar 

Sender D, Clark J, Hoffmann TC. Analysis of articles directly related to randomized trials finds poor protocol availability and inconsistent linking of articles. J Clin Epidemiol. 2020;124:69–74.

Article  Google Scholar 

Naudet F, Sakarovitch C, Janiaud P, Cristea I, Fanelli D, Moher D, et al. Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in the BMJ and PLOS medicine. BMJ. 2018;360:k400.

Article  Google Scholar 

Savage CJ, Vickers AJ. Empirical study of data sharing by authors publishing in PLoS journals. PLoS One. 2009;4(9):e7078.

Article  Google Scholar 

DeBlanc J, Kay B, Lehrich J, Kamdar N, Valley TS, Ayanian JZ, et al. Availability of statistical code from studies using medicare data in general medical journals. JAMA Intern Med. 2020;180(6):905–7.

Article  Google Scholar 

留言 (0)

沒有登入
gif