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

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          Abstract

          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.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s12910-015-0061-5) contains supplementary material, which is available to authorized users.

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          Most cited references 8

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          Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

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            Agreement between questionnaire data and medical records. The evidence for accuracy of recall.

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              Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment.

              To compare safety of salmeterol and salbutamol in treating asthma. Double blind, randomised clinical trial in parallel groups over 16 weeks. General practices throughout the United Kingdom. 25,180 patients with asthma considered to require regular treatment with bronchodilators who were recruited by their general practitioner (n = 3516). Salmeterol (Serevent) (50 micrograms twice daily) or salbutamol (200 micrograms four times a day) randomised in the ratio of two patients taking salmeterol to one taking salbutamol. All other drugs including prophylaxis against asthma were continued throughout the study. All serious events and reasons for withdrawals (medical and non-medical) whether or not they were considered to be related to the drugs. Fewer medical withdrawals due to asthma occurred in patients taking salmeterol than in those taking salbutamol (2.91% v 3.79%; chi 2 = 13.6, p = 0.0002). Mortality and admissions to hospital were as expected. There was a small but non-significant excess mortality in the group taking salmeterol and a significant excess of asthma events including deaths in patients with severe asthma on entry. Use of more than two canisters of bronchodilator a month was particularly associated with the occurrence of an adverse asthma event. Treatment over 16 weeks with either salmeterol or salbutamol was not associated with an incidence of deaths related to asthma in excess of that predicted. Overall control of asthma was better in patients allocated to salmeterol. Serious adverse events occurred in patients most at risk on entry and were probably due to the disease rather than treatment.
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                Author and article information

                Contributors
                ebileakoh@yahoo.com
                jateudj@yahoo.fr
                martinyakum@yahoo.com
                djngmarceau@yahoo.fr
                pwatcho@yahoo.fr
                Journal
                BMC Med Ethics
                BMC Med Ethics
                BMC Medical Ethics
                BioMed Central (London )
                1472-6939
                29 September 2015
                29 September 2015
                2015
                : 16
                Affiliations
                [ ]Department of Biomedical Sciences, University of Dschang, Dschang, Cameroon
                [ ]Division of Health Operations Research, Ministry of Public Health, Yaoundé, Cameroon
                [ ]M.A. SANTE (Meilleure Access aux soins de Santé), PO Box 33490, Yaoundé, Cameroon
                [ ]Department of Biochemistry, Faculty of Science, University of Yaoundé I, Yaoundé, Cameroon
                [ ]Ethics Committee for Research and Health in Central Africa, Yaoundé, Cameroun
                Article
                61
                10.1186/s12910-015-0061-5
                4589194
                26420169
                © Ebile et al. 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Medicine

                detection, reporting, investigation, adverse events, clinical trial, protocols, cameroon

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