Rajan Abinaya, Caldas Carlos, van Luenen Henri, Saghatchian Mahasti, van Harten Wim H
The Netherlands Cancer Institute, Amsterdam 1066 CX, The Netherlands.
J Transl Med. 2013 Oct 29;11:274. doi: 10.1186/1479-5876-11-274.
It takes several years on average to translate basic research findings into clinical research and eventually deliver patient benefits. An expert-based excellence assessment can help improve this process by: identifying high performing Comprehensive Cancer Centres; best practices in translational cancer research; improving the quality and efficiency of the translational cancer research process. This can help build networks of excellent Centres by aiding focused partnerships. In this paper we report on a consensus building exercise that was undertaken to construct an excellence assessment framework for translational cancer research in Europe.
We used mixed methods to reach consensus: a systematic review of existing translational research models critically appraised for suitability in performance assessment of Cancer Centres; a survey among European stakeholders (researchers, clinicians, patient representatives and managers) to score a list of potential excellence criteria, a focus group with selected representatives of survey participants to review and rescore the excellence criteria; an expert group meeting to refine the list; an open validation round with stakeholders and a critical review of the emerging framework by an independent body: a committee formed by the European Academy of Cancer Sciences.
The resulting excellence assessment framework has 18 criteria categorized in 6 themes. Each criterion has a number of questions/sub-criteria. Stakeholders favoured using qualitative excellence criteria to evaluate the translational research "process" rather than quantitative criteria or judging only the outputs. Examples of criteria include checking if the Centre has mechanisms that can be rated as excellent for: involvement of basic researchers and clinicians in translational research (quality of supervision and incentives provided to clinicians to do a PhD in translational research) and well designed clinical trials based on ground-breaking concepts (innovative patient stratification, substantial fraction of phase I/II trials, investigator-initiated trials). Critically, the framework supports reduced bureaucracy by building on existing European evaluation systems.
The excellence framework is the product of an intense stakeholder consensus building exercise. It will be piloted during an expert peer review/site visit of at least three European Comprehensive Cancer Centres. The findings regarding content, governance and implementation can have relevance for other clinical and research fields.
将基础研究成果转化为临床研究并最终为患者带来益处平均需要数年时间。基于专家的卓越性评估有助于通过以下方式改进这一过程：识别表现出色的综合癌症中心；转化癌症研究的最佳实践；提高转化癌症研究过程的质量和效率。这有助于通过促进有针对性的合作建立卓越中心网络。在本文中，我们报告了一项为构建欧洲转化癌症研究卓越性评估框架而开展的共识达成活动。
我们采用混合方法达成共识：对现有的转化研究模型进行系统综述，对其在癌症中心绩效评估中的适用性进行严格评估；对欧洲利益相关者（研究人员、临床医生、患者代表和管理人员）进行调查，以对一系列潜在的卓越标准进行评分，与调查参与者的选定代表进行焦点小组讨论，以审查和重新评分卓越标准；召开专家组会议以完善清单；与利益相关者进行公开验证轮，并由一个独立机构对新出现的框架进行批判性审查：由欧洲癌症科学学会组成的委员会。
最终的卓越性评估框架有18项标准，分为6个主题。每个标准都有一些问题/子标准。利益相关者倾向于使用定性卓越标准来评估转化研究“过程”，而不是定量标准或仅评判产出。标准示例包括检查该中心是否有可被评为卓越的机制：基础研究人员和临床医生参与转化研究（为临床医生攻读转化研究博士学位提供的监督质量和激励措施）以及基于开创性概念设计良好的临床试验（创新的患者分层、相当比例的I/II期试验、研究者发起的试验）。至关重要的是，该框架通过借鉴现有的欧洲评估系统来支持减少官僚作风。
卓越性框架是一项激烈的利益相关者共识达成活动的产物。它将在至少三个欧洲综合癌症中心的专家同行评审/实地考察期间进行试点。关于内容、治理和实施的调查结果可能与其他临床和研究领域相关。
