Jones Daryl A, Cooper D Jamie, Finfer Simon R, Bellomo Rinaldo, Myburgh John A, Higgins Alisa, Peake Sandra L, Jenkins Ian, McNeil John
Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Crit Care Resusc. 2007 Jun;9(2):198-204.
Over the past 12 years, the Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group and the broader intensive care community in Australia and New Zealand have established a track record for conducting high quality, investigator-initiated clinical research in critically ill patients. This is highlighted by the publication of the SAFE (Saline Albumin Fluid Evaluation) study in the New England Journal of Medicine and the MERIT (Medical Early Response Intervention and Therapy) study in the Lancet. Here, we discuss potential impediments to the further advancement of intensive care research in Australia and New Zealand, and suggest strategies to address them. We propose that there is a need to broaden the current research scope and develop more multifaceted research programs that address clinically important issues. We stress the need to also undertake phase II studies to assess safety, pharmacokinetics and biological plausibility of new and established therapies. In addition, we highlight limitations imposed by the relatively small regional population of Australia and New Zealand, and the need to develop international collaborations to allow trials requiring large sample sizes. We contend that the best chance of improving outcomes in many disease states requires studies to commence before patients enter the ICU, which will depend on collaboration with established and emerging craft groups, such as ambulance services, emergency medicine and anaesthesia. We also emphasise the need to study system factors affecting patient outcomes, as well as the translation of research findings into clinical practice. Finally, we describe the establishment and objectives of the Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) and outline the Centre's current projects in the context of an integrated research framework.
在过去12年里,澳大利亚和新西兰重症监护协会(ANZICS)临床试验小组以及澳大利亚和新西兰更广泛的重症监护界在对危重病患者开展高质量的、研究者发起的临床研究方面建立了良好记录。发表在《新英格兰医学杂志》上的SAFE(生理盐水白蛋白液体评估)研究以及发表在《柳叶刀》上的MERIT(医学早期反应干预与治疗)研究都凸显了这一点。在此,我们讨论澳大利亚和新西兰重症监护研究进一步发展的潜在障碍,并提出应对策略。我们认为有必要拓宽当前的研究范围,制定更多涉及临床重要问题的多方面研究计划。我们强调还需要开展II期研究,以评估新疗法和现有疗法的安全性、药代动力学及生物学合理性。此外,我们强调了澳大利亚和新西兰相对较小的地区人口所带来的限制,以及开展需要大样本量试验时发展国际合作的必要性。我们认为,在许多疾病状态下改善治疗结果的最佳机会在于在患者进入重症监护病房之前就开始研究,这将依赖于与既有和新兴专业团队的合作,如救护服务、急诊医学和麻醉学团队。我们还强调需要研究影响患者治疗结果的系统因素,以及将研究结果转化为临床实践。最后,我们描述了澳大利亚和新西兰重症监护研究中心(ANZIC-RC)的设立及其目标,并在综合研究框架的背景下概述了该中心目前的项目。