INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux Segalen University, Bordeaux, France.
Clin Trials. 2013 Apr;10(2):300-18. doi: 10.1177/1740774512470765. Epub 2013 Jan 23.
Since 1994, the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) has funded research sites in resource-limited countries (RLCs). These sites implement research on human immunodeficiency virus (HIV) infection and Hepatitis C. In parallel, international regulations and recommendations for clinical trials have evolved and proliferated. However, little guidance exists on how these should be interpreted and applied within academic trials and in the context of RLCs. After developing a specific Ethical Charter for research in developing countries in 2002, ANRS developed a set of quality indicators (QIs) as a monitoring tool for assessing compliance to international guidelines.
We describe here the development process, QIs adopted, and areas for improvement.
In 2008, a group of experts was convened that included a researcher representing each ANRS site (Cote d'Ivoire, Senegal, Cameroun, Burkina Faso, Egypt, and Cambodia). Our structuring interaction development process combined evidence and expert opinion in two nominal group meetings to identify (1) clinical trial processes involved, (2) issues specific to RLCs in terms of Good Clinical Practice (GCP) and the application of ethical recommendations, and (3) checklists of QIs adapted to clinical trials conducted in RLCs.
The trial process reviewed and proposed for RLCs was mostly similar to the one produced in wealthier countries. The scheme generated by our work group added two further processes: 'drug management' and 'biological investigations'. Specific issues regarding trial management in RLCs were therefore described for eight trial steps (1) protocol conception and seeking authorizations, (2) participant enrollment and follow-up, (3) site monitoring, (4) drug management, (5) biological investigations, (6) record management, (7) data management, and (8) site closeout. A total of 58 indicators were identified with at least one indicator for each trial process.
Some trial activities require further consideration, that is, in the case of vulnerable participants (children, pregnant women). Proposed indicators are the result of expert consensus and reflect their experience in the HIV field. Relevance to existing trials and extrapolation to other fields must be assessed.
This innovative program allowed ANRS sites located in RLCs to share their GCP implementation experiences in order to build a list of relevant indicators for clinical trials. The next step is to collect data from ongoing HIV and hepatitis C trials in these settings and will assess the relevance of these indicators to document current quality of performance among trials in resource-limited settings.
自 1994 年以来，法国国家艾滋病和病毒性肝炎研究署（ANRS）已资助资源有限国家（RLC）的研究点。这些研究点实施了人类免疫缺陷病毒（HIV）感染和丙型肝炎的研究。与此同时，临床试验的国际法规和建议也在不断发展和增加。然而，在学术试验和 RLC 背景下，如何解释和应用这些法规和建议几乎没有指导。在 2002 年制定了发展中国家研究的特定伦理章程后，ANRS 制定了一套质量指标（QIs）作为评估遵守国际准则的监测工具。
我们在此描述了开发过程、采用的质量指标和改进领域。
2008 年，召集了一组专家，包括代表 ANRS 每个研究点的研究员（科特迪瓦、塞内加尔、喀麦隆、布基纳法索、埃及和柬埔寨）。我们的结构互动开发过程结合了证据和专家意见，通过两次名义小组会议来确定（1）临床试验过程，（2）RLC 中涉及良好临床实践（GCP）和伦理建议应用的具体问题，以及（3）适用于 RLC 中进行的临床试验的质量指标检查表。
为 RLC 审查和提出的试验过程与在较富裕国家产生的过程基本相似。工作组生成的方案增加了另外两个过程：“药物管理”和“生物研究”。因此，为临床试验的八个步骤描述了与试验管理有关的特定问题（1）方案构思和寻求授权，（2）参与者招募和随访，（3）现场监测，（4）药物管理，（5）生物研究，（6）记录管理，（7）数据管理和（8）站点关闭。总共确定了 58 个指标，每个试验过程都至少有一个指标。
一些试验活动需要进一步考虑，即弱势参与者（儿童、孕妇）的情况。拟议的指标是专家共识的结果，反映了他们在 HIV 领域的经验。必须评估与现有试验的相关性和对其他领域的推断。
该创新计划使位于 RLC 的 ANRS 研究点能够分享他们实施 GCP 的经验，以建立适用于临床试验的相关指标列表。下一步是从这些环境中的正在进行的 HIV 和丙型肝炎试验中收集数据，并评估这些指标对记录资源有限环境中当前试验绩效的相关性。
