Meeting Report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017

Introduction: The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to standard of care (SoC) in HIV prevention clinical trials, both for treatment and prevention of disease. Policymakers, regulators, ethicists, experts in the law (as it pertains to medical research), researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. Discussion: Summit participants discussed how and when to include new modalities of HIV treatment and prevention into existing clinical practice guidelines, and by extension in clinical trial protocols. Participants involved in the execution of care and the scale-up of new interventions, in particular, the roll out of pre-exposure prophylaxis (PrEP), presented the opportunities for and challenges to scaling up interventions, and their experience with demonstration projects of PrEP. Advocates and community members propagated the need to make interventions that could avert HIV infection available as soon as possible. Experts in evidence-based guideline development discussed the nuances in evaluating evidence for policy and the mechanisms for getting medicines on the Essential Medicines List in South Africa. Given the variability in clinical trial efficacy of PrEP amongst different populations, scientists and statisticians discussed the various biological, virological and immunological reasons for this heterogeneity. Conclusions: Input was given as to the impact of introducing PrEP in other HIV prevention trials, and the considerations for the design of both antiretroviral (ARV)-based and non-ARV based HIV prevention trials. The meeting recommended supporting access to PrEP in HIV prevention trials by 1) developing PrEP access plans for HIV vaccine trials; 2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism; and 3) support the safety monitoring of PrEP.

引言：南非医学研究委员会（South African Medical Research Council, SAMRC）召开峰会，围绕HIV预防临床试验中用于疾病治疗与预防的护理标准（standard of care, SoC）相关议题展开研讨。政策制定者、监管人员、伦理学家、医学研究法律专家、研究人员、倡导团体代表，以及HIV疫苗试验网络（HIV Vaccine Trials Network, HVTN）的代表共同提出了一套可用于阐明护理标准原则的框架。

讨论环节：峰会参与者探讨了如何及何时将新型HIV治疗与预防手段纳入现行临床实践指南，并进一步延伸至临床试验方案中。参与临床护理执行与新型干预措施推广的参会者，特别是暴露前预防（pre-exposure prophylaxis, PrEP）的推广人员，分享了推广此类干预措施所面临的机遇与挑战，以及他们在PrEP示范项目中的实践经验。倡导人士与社区成员呼吁，应尽快为大众提供可预防HIV感染的干预手段。循证指南制定专家则讨论了政策制定中证据评估的细微差异，以及南非将药品纳入国家基本药物清单的相关机制。鉴于不同人群中PrEP临床试验疗效存在显著异质性，科学家与统计学家深入探讨了造成这种差异的各类生物学、病毒学与免疫学成因。

结论：与会人员就PrEP在其他HIV预防试验中的应用影响，以及基于抗逆转录病毒（antiretroviral, ARV）与非抗逆转录病毒的HIV预防试验的设计考量提出了相关意见。本次会议提出三项支持HIV预防试验中PrEP可及性的建议：1）为HIV疫苗试验制定PrEP可及性方案；2）设立PrEP专项基金，通过集中采购机制为开展HIV预防试验的研究站点供应PrEP；3）支持PrEP的安全性监测工作。