Left in the dark: the importance of publicly available clinical trial protocols

Sabine Braat^{1

2}, Katherine J Lee^{3

4}

Affiliations

¹ Centre for Epidemiology and Biostatistics, the University of Melbourne, Melbourne, VIC.
² MISCH (Methods and Implementation Support for Clinical Health) research hub, the University of Melbourne, Melbourne, VIC.
³ Murdoch Children's Research Institute, Melbourne, VIC.
⁴ The University of Melbourne, Melbourne, VIC.

Editorial

Sabine Braat et al. Med J Aust. 2022.

. 2022 Nov 21;217(10):519-520.

doi: 10.5694/mja2.51773.

Sabine Braat^{1

2}, Katherine J Lee^{3

4}

¹ Centre for Epidemiology and Biostatistics, the University of Melbourne, Melbourne, VIC.
² MISCH (Methods and Implementation Support for Clinical Health) research hub, the University of Melbourne, Melbourne, VIC.
³ Murdoch Children's Research Institute, Melbourne, VIC.
⁴ The University of Melbourne, Melbourne, VIC.

No abstract available

Keywords: Clinical trials as topic; Guidelines as topic; Publishing; Randomized controlled trial as topic.

Comment on

Changes to design and analysis elements of research plans during randomised controlled trials in Australia.
Coskinas X, Simes RJ, Martin AJ. Coskinas X, et al. Med J Aust. 2022 Nov 21;217(10):526-531. doi: 10.5694/mja2.51715. Epub 2022 Sep 11. Med J Aust. 2022. PMID: 36089816 Free PMC article.

1. Coskinas X, Simes RJ, Martin AJ. Changes to design and analysis elements of research plans during randomised controlled trials in Australia. Med J Aust 2022; 217: 526-531.
1. Chan AW, Hróbjartsson A. Promoting public access to clinical trial protocols: challenges and recommendations. Trials 2018; 19: 116.
1. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158: 200-207.
1. 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: 2457-2465.
1. Mathieu S, Boutron I, Moher D, et al. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009; 302: 977-984.