Bonnes Pratiques Cliniques dans les pays en développement : recommandations en termes d’application

Bompart, François; Hirsch, François; Bertoye, P; Vray, Muriel

doi:10.2515/therapie:2008022

Cited by 4 publications

(4 citation statements)

References 13 publications

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“…Various research groups share this position (Ravinetto et al. 2010c); Bompart et al. (2008) even recommended that double ethical review of externally sponsored trials become a regulatory requirement (Bompart et al.…”

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confidence: 99%

Double ethical review of North–South collaborative clinical research: hidden paternalism or real partnership?

Ravinetto

Buvé

Tinto

et al. 2011

Tropical Med Int Health

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SummaryDespite their universal character, the ethical principles governing clinical research need to be translated into procedures and practices, which will vary among countries and regions because of differences in local cultural norms and in the available resources. Double ethical review, by which a research protocol is submitted for ethical clearance both in the country or countries where the research takes place and in the country of the sponsor or funding agency, will then help ensure that all relevant perspectives are taken into account. In addition, a geographically and culturally close ethics committee can do a much better informed and comprehensive assessment of the respective skills of the clinical sites and of the sponsor. But the practical implementation of double ethical review can bring significant difficulties and delays, especially in multi-site and multi-country researches. Currently, most ethics committees do not proactively seek communication with others evaluating the same research protocol in different socioeconomical and cultural contexts, so in practice there is no mutual learning process. Proactive communication would help to build collaborative partnership among ethical bodies, promoting common practices and resolving conflicting opinions.

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confidence: 99%

Double ethical review of North–South collaborative clinical research: hidden paternalism or real partnership?

Ravinetto

Buvé

Tinto

et al. 2011

Tropical Med Int Health

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“…The International Conference of Harmonization on Good Clinical Practice (ICH-GCP),the WHO guidelines, the WHO Strategy on Research for Health, and the Consolidated Standard for Reporting Trials (CONSORT) extension on Harms recommend ethical and scientific standards for conducting, and reporting results of clinical trials. Clinical trials need to be developed carefully to give a fair and balance report between risks and benefits, wherever the research is conducted [ 15 – 17 ]. Clinical trials have a goal to assess the safety and efficacy of the product/intervention under investigation [ 6 ].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2015

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BackgroundInternational 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.MethodsIt 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.ResultsIn 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.DiscussionsMost 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.ConclusionClinical 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 materialThe 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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“…16 The Council for International Organizations of Medical Sciences (CIOMS) Guidelines and the Nuffield Council on Bioethics recommend that they are subject to the ‘double ethical review’, that is, ethical review carried out in the study country and in the sponsor's country. 16 25 This mechanism is also suggested by independent research groups, 26 but it is generally not legally enforced, and the international GCP codes are silent on it.…”

Section: A Practice-based Set Of Recommendationsmentioning

confidence: 99%

It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North–South collaborative trials

Ravinetto

Tinto²,

Diro

et al. 2016

BMJ Glob Health

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The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of ‘externally sponsored’ trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes de facto guide national legislators and funding agencies, so the current shortcomings may weaken the regulatory oversight of international research. In addition, activities neglected by GCP are less likely to be implemented or funded. If GCP are meant to serve the interests of global society, a comprehensive revision is needed. The revised guidelines should be strongly rooted in ethics, sensitive to different sociocultural perspectives, and allow consideration for trial-specific and context-specific challenges. This can be only achieved if all stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients' representatives from LMICs, as well as non-commercial researchers and sponsors from affluent countries, are transparently involved in the revision process. We hope that our limited analysis would foster advocacy for a broad and inclusive revision of the international GCP codes, to make them at the same time ‘global’, ‘context centred’ and ‘patient centred’.

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Bonnes Pratiques Cliniques dans les pays en développement : recommandations en termes d’application

Cited by 4 publications

References 13 publications

Double ethical review of North–South collaborative clinical research: hidden paternalism or real partnership?

Double ethical review of North–South collaborative clinical research: hidden paternalism or real partnership?

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

It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North–South collaborative trials

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