Discipline, Palliative and Supportive Services, Flinders University, Australia.
Palliat Med. 2012 Dec;26(8):1042-7. doi: 10.1177/0269216311417036. Epub 2011 Aug 15.
Rigorous clinical research in palliative care is challenging but achievable. Trial participants are likely to have deteriorating performance status, co-morbidities and progressive disease. It is difficult to recruit patients, and attrition unrelated to the intervention being trialled is high. The aim of this paper is to highlight practical considerations from a forum held to discuss these issues by active palliative care clinical researchers. To date, the Australian Palliative Care Clinical Studies Collaborative (PaCCSC) has randomized more than 500 participants across 12 sites in 8 Phase III studies. Insights from the 2010 clinical research forum of the PaCCSC are reported. All active Australian researchers in palliative care were invited to present their current research and address three specific questions: (1) What has worked well? (2) What didn't work well? and (3) How should the research be done differently next time? Fourteen studies were presented, including six double-blind, randomized, controlled, multi-site trials run by the PaCCSC. Key recommendations are reported, including guidance on design; methodologies; and strategies for maximizing recruitment and retention. These recommendations will help to inform future trial design and conduct in palliative care.
在姑息治疗中进行严格的临床研究具有挑战性，但也是可行的。试验参与者的表现状态、合并症和疾病进展可能会恶化。招募患者较为困难，且与正在试验的干预措施无关的脱落率较高。本文旨在通过积极从事姑息治疗临床研究的人员举办的论坛，重点介绍这些问题的实际考虑因素。迄今为止，澳大利亚姑息治疗临床研究协作组（PaCCSC）已在 8 项 3 期研究中的 12 个地点随机分配了 500 多名参与者。报告了 PaCCSC 2010 年临床研究论坛的见解。邀请所有积极从事姑息治疗的澳大利亚研究人员介绍他们目前的研究，并回答三个具体问题：（1）哪些做得好？（2）哪些做得不好？（3）下次应该如何以不同的方式进行研究？介绍了 14 项研究，其中包括由 PaCCSC 进行的 6 项双盲、随机、对照、多地点试验。报告了关键建议，包括设计、方法学以及最大限度提高招募和保留率的策略的指导。这些建议将有助于为姑息治疗中的未来试验设计和实施提供信息。
