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Public Access to Protocols of Contemporary Cancer Randomized Clinical Trials

Overview
Journal Trials
Publisher Biomed Central
Specialties General Medicine
Pharmacology
Date 2021 Jun 28
PMID 34176506
Citations 4
Authors
Christopher Babu
Loren Mell
Nancy Lee
Kaveh Zakeri
Affiliations
Soon will be listed here.
Abstract

Access to randomized clinical trial (RCT) protocols is necessary for the interpretation and reproducibility of the study results, but protocol availability has been lacking. We determined the prevalence of protocol availability for all published cancer RCTs in January 2020. We found that only 36.1% (48/133) of RCTs had an accessible protocol and only 11.3% of RCTs (15/133) had a publicly accessible protocol that was not behind a paywall. Only 18.0% (24/133) of RCTs were published in conjunction with the protocol on the journal website. In conclusion, few cancer RCTs have an accessible research protocol. Journals should require publication of RCT protocols along with manuscripts to improve research transparency.

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Campbell D, McDonald C, Cro S, Jairath V, Kahan B Trials. 2022; 23(1):674.

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References
1.
Boutron I, Dutton S, Ravaud P, Altman D . Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA. 2010; 303(20):2058-64. DOI: 10.1001/jama.2010.651. View
2.
Mell L, Lau S, Rose B, Jeong J . Reporting of cause-specific treatment effects in cancer clinical trials with competing risks: a systematic review. Contemp Clin Trials. 2012; 33(5):920-4. DOI: 10.1016/j.cct.2012.05.013. View
3.
Lucey M, Clark J, Glasziou P . Public availability of trial protocols. Lancet. 2017; 390(10113):e54-e55. DOI: 10.1016/S0140-6736(17)33255-5. View
4.
Altman D, Furberg C, Grimshaw J, Rothwell P . Lead editorial: trials - using the opportunities of electronic publishing to improve the reporting of randomised trials. Trials. 2006; 7:6. PMC: 1449870. DOI: 10.1186/1745-6215-7-6. View
5.
Zakeri K, Noticewala S, Vitzthum L, Sojourner E, Shen H, Mell L . 'Optimism bias' in contemporary national clinical trial network phase III trials: are we improving?. Ann Oncol. 2018; 29(10):2135-2139. PMC: 6454418. DOI: 10.1093/annonc/mdy340. View