Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols

BMC Medical Ethics

Pierre Watcho²  Marceline Ngounoue Djuidje¹  Martin Ndinakie Yakum³  Jerome Ateudjieu³  Akoh Walter Ebile³ 

[1] Ethics Committee for Research and Health in Central Africa, Yaoundé, Cameroun;Department of Biomedical Sciences, University of Dschang, Dschang, Cameroon;M.A. SANTE (Meilleure Access aux soins de Santé), Yaoundé, Cameroon

关键词: Cameroon;    Protocols;    Clinical trial;    Adverse events;    Investigation;    Reporting;    Detection;   

Others  :  1229738
DOI  :  10.1186/s12910-015-0061-5

 received in 2015-01-30, accepted in 2015-09-22,  发布年份 2015

【 摘 要 】

Background

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned.

Methods

It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety.

Results

In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events.

Discussions

Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols.

Conclusion

Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.

【 授权许可】

   
2015 Ebile et al.

【 图 表 】

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