Assessing the planning to detect, report and to investigate adverse events in clinical trial protocols implemented in Cameroon

Thesis presented and defended publicly in order to obtain a Professional Master Degree in Epidemiology and Public Health, Department of Biomedical Sciences, Faculty of Sciences, University of Dschang

Academic year 2013-2014

Student: Ebile Akoh Walter 1

ebileakoh@yahoo.fr

Director: Dr ATEUDJIEU Jérôme, MD, MPH, Ph.D 123

jateudj@yahoo.fr ; Jerome.ateudjieu@masante-cm.org

Supervisor: Pr WATCHO Pierre, Ph.D 1

Funded by :    DOVE PROJECT  ; M.A. SANTE

Abstract

Background: The ICH guidelines for Good Clinical Practice recommends ethical and scientific quality standards for designing, conducting, recording and reporting all adverse events occurring during clinical trials to competent research ethics committee and regulatory authorities. These recommendations have to be taken into consideration when developing protocols to be submitted for ethical review. The objective of this study was to determine if clinical trial protocols submitted for review in the Cameroon National ethics committee from 1997 to 2012 are in line with national requirements and international guidelines as far as detecting, reporting and investigation of adverse events during clinical trials is concerned.

Methods: It was an observational descriptive study involving a documentary review of all clinical trial protocols that were submitted at the Cameroon National Ethics Committee for review. Data were collected using a preconceived grid. The review process targeted the title, summary, objectives, methodology, resources and safety elements. Data were entered, and analyzed using EPI INFO 3.5.4 and STATA12.

Results: One hundred and six (4.9%) of 2173 protocols submitted were clinical trial protocols. Among which 94(4.3%) of them were eligible for the study and were reviewed. For the 94 clinical trial protocols that were reviewed, 64 (70.3%) did not include adverse event surveillance as part of their research objectives, and 19.8% included adverse events as one of the outcome. Also, 43(54.3%) did not have a case definition for severe adverse events, 24(25.5%) had described a clear adverse event detection procedure, 31(33.0%) had a reporting procedure and 18(19.1%) had an adverse event investigation procedure. Eighty two (87.2%) had no budget to survey adverse events. Sixty six (70.2%) did not have a data safety management board (DSMB), 90.4 %( 85) did not plan for participants insurance care and 45(55.2%) did not have a case report form (CRF).

Conclusion: The findings of this study shows that Clinical trials in Cameroon suffer from poor resource planning and that the procedures of conducting, recording, reporting and assessing adverse events during clinical trials in Cameroon are not in compliance with national requirements as well as international norms regarding ethical and scientific standards of Good Clinical Practice. Intervention needs include development of standard operating procedures and national directives or guidelines for conducting clinical trials in Cameroon as well as the training of researchers, sponsors, and members of regulatory authorities on the conducts of good clinical practice. Key words: Adverse events, clinical trial, surveillance, ethics committees

  1. Department of Biomedical Sciences, Faculty of Sciences, University of Dschang
  2. Division of Health Operational Research, Ministry of Public Health, Cameroon
  3. A. SANTE (Meilleur Accès aux Soins de Santé/ Better Access to Health Care)