Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland, USA.
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
J Med Ethics. 2018 May;44(5):354-358. doi: 10.1136/medethics-2017-104637. Epub 2018 Feb 27.
Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA.
伦理学指南越来越多地认识到，研究人员和赞助商有义务考虑对研究中发现有益的干预措施进行试验后获取（PTA）的规定。然而，关于此类计划实际上是否以及如何实施的信息却很少。了解制定和实施这些计划的实际经验对于优化其实施和为与 PTA 相关的概念工作提供信息都至关重要。本观点是基于 HIV 预防试验网络支持的六项大型多中心 HIV 预防试验制定和实施 PTA 计划的经验得出的。这些经验表明，规划和实施 PTA 通常涉及在不确定的情况下进行规划以及面对获取医疗保健系统的实际障碍的挑战。即使在经过测试的干预药物已获得批准并在当地医疗保健系统中可用的相对有利的情况下，系统层面的障碍也可能威胁到 PTA 计划的可行性。这些 HIV 预防试验的综合经验表明，仅仅将参与者转介到当地医疗保健系统进行 PTA，不一定会导致试验参与者继续获得有益的干预措施。对 PTA 的认真承诺将需要进一步努力，从未来的方法中吸取经验教训，通过专门的后续行动来衡量 PTA 计划的成功，并进一步制定规范指南，帮助研究利益相关者应对实现 PTA 的复杂实际挑战。
