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扩大公私合作以加强癌症药物研发:医学研究所研讨会系列报告,“为21世纪建立国家癌症临床试验系统”

Expanding public-private collaborations to enhance cancer drug development: a report of the Institute of Medicine's workshop series, "Implementing a National Cancer Clinical Trials System for the 21st Century".

作者信息

Bertagnolli Monica M, Canetta Renzo, Nass Sharyl J

机构信息

Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, USA; Bristol-Myers Squibb, Wallingford, Connecticut, USA; National Cancer Policy Forum, Institute of Medicine of the National Academies, Washington, D.C., USA

Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts, USA; Bristol-Myers Squibb, Wallingford, Connecticut, USA; National Cancer Policy Forum, Institute of Medicine of the National Academies, Washington, D.C., USA.

出版信息

Oncologist. 2014 Nov;19(11):1179-85. doi: 10.1634/theoncologist.2014-0240. Epub 2014 Oct 17.

Abstract

Since their inception in the 1950s, the National Cancer Institute-funded cancer cooperative groups have been important contributors to cancer clinical and translational research. In 2010, a committee appointed by the Institute of Medicine (IOM) of the National Academy of Sciences completed a consensus review on the status of the U.S. publicly funded cancer clinical trials system. This report identified a need to reinvigorate the cooperative groups and provided recommendations for improving their effectiveness. Follow-up workshops to monitor progress were conducted by the IOM's National Cancer Policy Forum and the American Society of Clinical Oncology (ASCO) in 2011 and 2013. One of the key recommendations of the IOM report was a call for greater collaboration among stakeholders in cancer research. In particular, more active engagement and better alignment of incentives among the cooperative groups, the National Cancer Institute, the U.S. Food and Drug Administration, and the biopharmaceutical industry were identified as essential to achieving the promise of oncology drug development. This review, based on presentations and discussion during the IOM-ASCO workshops, outlines the progress and remaining challenges of these collaborations.

摘要

自20世纪50年代成立以来,由美国国立癌症研究所资助的癌症协作组一直是癌症临床和转化研究的重要贡献者。2010年,美国国家科学院医学研究所(IOM)任命的一个委员会完成了对美国公共资助癌症临床试验系统现状的共识性审查。该报告指出有必要重振协作组,并提出了提高其有效性的建议。2011年和2013年,IOM的国家癌症政策论坛和美国临床肿瘤学会(ASCO)举办了后续研讨会以监测进展情况。IOM报告的一项关键建议是呼吁癌症研究利益相关者之间加强合作。特别是,协作组、美国国立癌症研究所、美国食品药品监督管理局和生物制药行业之间更积极的参与和更好地协调激励措施被认为是实现肿瘤药物开发前景的关键。本综述基于IOM-ASCO研讨会期间的报告和讨论,概述了这些合作的进展和尚存的挑战。

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