Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review

BMC Medical Ethics

Henk J Out²  Gerard A Rongen³  Marlies van Lent¹ 

[1]Clinical Research Centre Nijmegen, Department of Pharmacology – Toxicology, Radboud University Medical Center, Nijmegen, The Netherlands

[2]Teva Pharmaceuticals, Amsterdam, The Netherlands

[3]Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands

关键词: Shortcomings;    Pharmaceutical industry;    Sponsorship;    Drug trials;    Research protocols;    Ethical review;    Research ethics committees;   

Others  :  1089965
DOI  :  10.1186/1472-6939-15-83

 received in 2014-08-19, accepted in 2014-11-26,  发布年份 2014

【 摘 要 】

Background

Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials.

Methods

Retrospective analysis of 226 protocols of drug trials approved in 2010–2011 by three RECs affiliated to academic medical centres in The Netherlands. For each protocol, information on sponsorship, number of participating centres, participating countries, study phase, registration status of the study drug, and type and number of subjects was retrieved. REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature.

Results

Most protocols received comments regarding participant information and consent forms (n = 182, 80.5%), methodology and statistical analyses (n = 160, 70.8%), and supporting documentation, including trial agreements and certificates of insurance (n = 154, 68.1%). Of the submitted protocols, 122 (54.0%) were non-industry and 104 (46.0%) were industry-sponsored trials. Non-industry trials more often received comments on subject selection (n = 44, 36.1%) than industry-sponsored trials (n = 18, 17.3%; RR, 1.58; 95% CI, 1.01 to 2.47), and on methodology and statistical analyses (n = 95, 77.9% versus n = 65, 62.5%, respectively; RR, 1.18; 95% CI, 1.01 to 1.37). Non-industry trials less often received comments on supporting documentation (n = 72, 59.0%) than industry-sponsored trials (n = 82, 78.8%; RR, 0.83; 95% CI, 0.72 to 0.95).

Conclusions

RECs identified important ethical and methodological shortcomings in protocols of both industry-sponsored and non-industry drug trials. Investigators, especially of non-industry trials, should better prepare their research protocols in order to facilitate the ethical review process.

【 授权许可】

   
2014 van Lent et al.; licensee BioMed Central Ltd.

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