Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials
Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials
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DOI：
10.1016/s2352-3018(19)30133-x
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发表时间：
2019-07-01
期刊：
影响因子：
16.1
通讯作者：
Nason, Martha
中科院分区：
文献类型：
--
作者：
Janes, Holly;Donnell, Deborah;Nason, Martha
尽管抗逆转录病毒药物最近在预防艾滋病毒方面取得了成功，但最终仍需要更多、更有效或更可接受的生物医学干预措施来结束艾滋病毒的流行。设计临床试验以评估降低艾滋病毒感染风险的新产品的功效是一项挑战，因为存在高度有效的预防艾滋病毒的干预措施。然而，这些干预措施的实施是不平衡的，目前正在评估新产品的多项艾滋病毒预防功效试验意味着该领域面临着新的预防标准的不确定性。在本观点中，我们评估了艾滋病毒预防的现状，并随后讨论了设计未来试验以评估下一代艾滋病毒预防产品的关键挑战。我们还强调了需要解决的知识基础的差距，以推进研究的设计。未来的试验是站得住脚的，即使在现有的和有效的干预措施的背景下，并应涉及仔细的统计方法和多学科的合作设计。
Despite the recent success of antiretrovirals for HIV prevention, additional, more effective, or more acceptable biomedical interventions will ultimately be needed to end the HIV epidemic. Designing clinical trials to evaluate the efficacy of new products that reduce HIV infection risk is challenging because of the existence of highly effective interventions to prevent HIV. However, the implementation of these interventions is uneven, and the fact that multiple HIV prevention efficacy trials are currently evaluating new products means the field confronts uncertainty in the emerging standard of prevention. In this Viewpoint, we take stock of the current state of HIV prevention, and subsequently discuss the key challenges in designing future trials to evaluate the next generation of HIV prevention products. We also highlight gaps in the knowledge base that need to be addressed to advance the design of research. Future trials are tenable, even in the context of existing and effective interventions, and should involve careful statistical approaches and multidisciplinary collaborative design.