Ravinetto Raffaella, Tinto Halidou, Diro Ermias, Okebe Joseph, Mahendradhata Yodi, Rijal Suman, Gotuzzo Eduardo, Lutumba Pascal, Nahum Alain, De Nys Katelijne, Casteels Minne, Boelaert Marleen
Public Health Department, Institute Tropical Medicine, Antwerp, Belgium.
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
BMJ Glob Health. 2016 Nov 16;1(3):e000122. doi: 10.1136/bmjgh-2016-000122. eCollection 2016.
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 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'.
世界卫生组织（WHO）和国际协调会议的《药物临床试验质量管理规范》（GCP）准则为临床研究制定了国际标准。但批评人士认为，这些准则在制定时没有考虑低收入和中等收入国家（LMICs）所面临的挑战。基于我们在低收入和中等收入国家的实地经验，我们制定了一套非详尽的改进GCP的建议。这些建议涵盖3个领域：伦理、法律和操作，以及8个具体问题：“外部资助”试验的双重伦理审查；未成年人和文盲人群的知情同意程序；试验社区在试验后获得新开发产品的机会；社区作为关键研究参与者的作用；申办者的定义；以及合同协议、实验室质量管理体系和研究用药品质量保证的指南。我们的分析未涵盖的问题包括生物样本库、医疗护理标准和研究设计等。国际GCP准则指导国家立法者和资助机构，因此当前的缺陷可能会削弱对国际研究的监管。此外，GCP忽视的活动不太可能得到实施或资助。如果GCP旨在服务全球社会的利益，就需要进行全面修订。修订后的指南应牢固地植根于伦理，对不同的社会文化观点保持敏感，并允许考虑特定试验和特定背景的挑战。只有当所有利益相关者，包括来自低收入和中等收入国家的研究人员、申办者、监管机构、伦理审查员和患者代表，以及富裕国家的非商业研究人员和申办者，都透明地参与修订过程时，才能实现这一点。我们希望我们有限的分析将促进对国际GCP准则进行广泛和包容性修订的倡导，使其同时具有“全球性”、“以背景为中心”和“以患者为中心”的特点。
