EORTC Headquarters, Avenue Mounier 83/11, 1200 Brussels, Belgium.
U.Z. Leuven Campus Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium.
Nat Rev Clin Oncol. 2014 Aug;11(8):492-8. doi: 10.1038/nrclinonc.2014.98. Epub 2014 Jun 17.
Health systems and the clinical research landscape evolve continuously owing to increased risk aversion, scrutiny by funding bodies, and costs of clinical trials. In this context, however, current drug development procedures are far from optimal, as exemplified by the late-stage failure of several drugs. The identification of new drugs urgently requires approaches based on a solid understanding of cancer biology, and that will support the design of robust confirmatory trials. The complexity and the costs of drug development are now beyond the knowledge and operational capacity of single organisations, therefore, a drastic deviation from the traditional path of drug discovery and new forms of multidisciplinary partnerships are needed to succeed in this sector. The European Organisation for Research and Treatment of Cancer (EORTC) proposes the use of collaborative molecular screening platforms (CMSPs) as a new approach to tackle this issue. These CMSPs have the advantage of optimizing the expertise of several partners and combining efforts alongside with cost-sharing models for efficient patient selection. This article describes some of the challenges to advancing drug development and improving medical treatments and how these hurdles can be overcome.
由于风险规避意识增强、资助机构审查力度加大以及临床试验成本增加,医疗体系和临床研究格局不断演变。然而,在这种背景下,当前的药物开发程序远非最佳,一些药物在后期阶段失败就是例证。新药的研发迫切需要基于对癌症生物学的深入了解,并支持设计稳健的确证性试验。药物开发的复杂性和成本已经超出了单个组织的知识和运营能力,因此,需要从传统的药物发现路径和新的多学科合作形式中进行重大转变,才能在这一领域取得成功。欧洲癌症研究与治疗组织(EORTC)提出使用协作分子筛选平台(CMSP)作为解决这一问题的新方法。这些 CMSP 的优势在于优化了几个合作伙伴的专业知识,并通过成本分担模式为有效的患者选择提供支持。本文介绍了推进药物开发和改善医疗的一些挑战,以及如何克服这些障碍。