Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)

Author:

Gryaznov DmitryORCID,von Niederhäusern Belinda,Speich BenjaminORCID,Kasenda Benjamin,Ojeda-Ruiz ElenaORCID,Blümle Anette,Schandelmaier Stefan,Mertz DominikORCID,Odutayo Ayodele,Tomonaga Yuki,Amstutz AlainORCID,Pauli-Magnus Christiane,Gloy Viktoria,Lohner Szimonetta,Bischoff Karin,Wollmann Katharina,Rehner Laura,Meerpohl Joerg J,Nordmann Alain,Klatte Katharina,Ghosh Nilabh,Taji Heravi Ala,Wong Jacqueline,Chow Ngai,Hong Patrick,McCord - De Iaco Kimberly A,Sricharoenchai Sirintip,Busse Jason WORCID,Agarwal ArnavORCID,Saccilotto Ramon,Schwenkglenks Matthias,Moffa Giusi,Hemkens Lars,Hopewell Sally,Von Elm ErikORCID,Briel Matthias

Abstract

ObjectivesComprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist in 2013. We aimed to examine the quality of reporting of RCT protocols from three countries before and after the publication of the SPIRIT checklist.DesignRepeated cross sectional study.SettingSwiss, German and Canadian research ethics committees (RECs).ParticipantsRCT protocols approved by RECs in 2012 (n=257) and 2016 (n=292).Primary and secondary outcome measuresThe primary outcomes were the proportion of reported SPIRIT items per protocol and the proportion of trial protocols reporting individual SPIRIT items. We compared these outcomes in protocols approved in 2012 and 2016, and built regression models to explore factors associated with adherence to SPIRIT. For each protocol, we also extracted information on general trial characteristics and assessed whether individual SPIRIT items were reportedResultsThe median proportion of reported SPIRIT items among RCT protocols showed a non-significant increase from 72% (IQR, 63%–79%) in 2012 to 77% (IQR, 68%–82%) in 2016. However, in a preplanned subgroup analysis, we detected a significant improvement in investigator-sponsored protocols: the median proportion increased from 64% (IQR, 55%–72%) in 2012 to 76% (IQR, 64%–83%) in 2016, while for industry-sponsored protocols median adherence was 77% (IQR 72%–80%) for both years. The following trial characteristics were independently associated with lower adherence to SPIRIT: single-centre trial, no support from a clinical trials unit or contract research organisation, and investigator-sponsorship.ConclusionsIn 2012, industry-sponsored RCT protocols were reported more comprehensively than investigator-sponsored protocols. After publication of the SPIRIT checklist, investigator-sponsored protocols improved to the level of industry-sponsored protocols, which did not improve.

Funder

Swiss National Science Foundation

Swiss Federal Office of Public Health

Publisher

BMJ

Subject

General Medicine

Reference26 articles.

1. World Medical Association . WMA Declaration of Helsinki - ethical principles for medical research involving human subjects, 2013. Available: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/2020

2. Comparison of protocols and registry entries to published reports for randomised controlled trials;Dwan;Cochrane Database Syst Rev,2011

3. Guidelines for randomized clinical trial protocol content: a systematic review

4. Adverse Event Reporting in Publications Compared With Sponsor Database for Cancer Clinical Trials

5. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study

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