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Gynecological Cancers Translational Research Implementation and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions

机译：妇科癌症的转化研究实施和协调：妇科癌症群体间共识和尚待解决的问题

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摘要

In the era of personalized medicine, the introduction of translational studies in clinical trials has substantially increased their costs, but provides the possibility of improving the productivity of trials with a better selection of recruited patients. With the overall goal of creating a roadmap to improve translational design for future gynecological cancer trials and of defining translational goals, a main discussion was held during a brainstorming day of the Gynecologic Cancer InterGroup (GCIG) Translational Research Committee and overall conclusions are here reported. A particular emphasis was dedicated to the new frontier of the immunoprofiling of gynecological cancers. The discussion pointed out that to maximize patients’ benefit, translational studies should be integral to clinical trial design with standardization and optimization of procedures including a harmonization program of Standard Operating Procedures. Pathology-reviewed sample collection should be mandatory and ensured by dedicated funding. Biomarker validation and development should be made public and transparent to ensure rapid progresses with positive outcomes for patients. Guidelines/templates for patients’ informed consent are needed. Importantly for the public, recognized goals are to increase the involvement of advocates and to improve the reporting of translational data in a forum accessible to patients.
机译：在个性化医学时代，将转化研究引入临床试验已大大增加了其成本，但提供了通过更好地选择招募患者来提高试验生产率的可能性。为了制定路线图以改善未来的妇科癌症试验的翻译设计并确定翻译目标的总体目标，在妇科癌症间小组（GCIG）转化研究委员会的集思广益之日进行了主要讨论，并在此报告了总体结论。特别强调致力于妇科癌症免疫谱分析的新领域。讨论指出，为使患者受益最大化，转化研究应成为临床试验设计不可或缺的部分，包括标准化和优化程序（包括标准操作程序的统一程序）。经病理检查的样本收集应是强制性的，并应通过专用资金来确保。生物标志物的验证和开发应公开且透明，以确保快速进展并为患者带来积极成果。需要患者知情同意的指南/模板。对于公众而言，重要的一点是，公认的目标是增加倡导者的参与并改善患者可访问的论坛中翻译数据的报告。

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