NIH, FDA Partnership Designed To Improve Clinical Trials

Owen Skoler

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NIH, FDA Partnership Designed To Improve Clinical Trials

机译：NIH与FDA合作旨在改善临床试验

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An initiative between the NIH and FDA to advance regulatory science could help drugmak-ers cut clinical trial costs and boost trial success.rnThe newly formed partnership, for example, could provide drugmakers with clearer guidance on trial design to ensure data meets FDA expectations for drug approval, according to Peter Pitts, president of the Center for Medicine in the Public Interest.rn"Most programs fail in late Stage 3 development and are not really sustainable," Pitts, former FDA associate commissioner for external relations, told WDL last week. "Initially, collaboration will allow companies to fail faster, and that's important, because ultimately it will help them succeed faster."

机译：美国国立卫生研究院（NIH）与FDA之间的一项旨在促进监管科学的举措可以帮助制毒者降低临床试验成本并提高试验成功率。例如，新成立的合作伙伴关系可以为制药商提供更清晰的试验设计指南，以确保数据符合FDA对药物的期望据公共利益医学中心主席彼得·皮茨（Peter Pitts）称，批准。 “最初，协作将使公司更快地失败，这很重要，因为最终它将帮助他们更快地成功。”

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《Washington Drug Letter》 |2010年第9期|7|共1页
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Owen Skoler;
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1. Twenty Years Post-NIH Revitalization Act: Enhancing Minority Participation in Clinical Trials (EMPaCT): Laying the Groundwork for Improving Minority Clinical Trial Accrual Renewing the Case for Enhancing Minority Participation in Cancer Clinical Trials [J] . Moon S. Chen Jr, Primo N. Lara, Julie H. T. Dang, Cancer: A Journal of the American Cancer Society . 2014,第7Suppla期

机译：美国国立卫生研究院（NIH）振兴法案颁布二十周年：增强少数族裔对临床试验的参与（EMPaCT）：为改善少数族裔临床试验的基础打下基础，为进一步增加少数族裔参与癌症临床试验的案件奠定基础
2. Clinical trial metadata: Defining and extracting metadata on the design, conduct, results and costs of 125 randomised clinical trials funded by the NIHR Health Technology Assessment Programme [J] . Raftery?J, Young?A, Stanton?L, Health technology assessment: HTA . 2015,第11期

机译：临床试验元数据：在NIHR健康技术评估计划资助下，定义和提取有关125项随机临床试验的设计，行为，结果和费用的元数据
3. 臨床研究の推進及び円滑化を目的としたひな形作成に関する取り組み NIH-FDA Clinical Trial Protocol Templateと日本の規制に合わせた検討 [J] . 寺田麻里, 小早川雅男, 大津洋, 臨床薬理: Japanese journal of clinical pharmacology . 2019,第4期

机译：为临床研究做准备促进促进的倡议。
4. Patient in control in clinical trials - European initiatives for improving patient empowerment in clinical trials through technical implementation of legal norms [C] . Forgo Nikolaus, Goralczyk Magdalena, Hanold Stefanie Annual Conference of Japanese Society for Medical and Biological Engineering;Annual International Conference of the IEEE Engineering in Medicine and Biology Society . 2013

机译：在临床试验中控制患者-通过法律规范的技术实施来提高临床试验中患者的能力的欧洲倡议
5. Effects of trial design on participation and costs in clinical trials, with an examination of cost analysis methods and data sources. [D] . Kilgore, Meredith L. 2004

机译：试验设计对临床试验参与和费用的影响，并检查费用分析方法和数据源。
6. Vol-PACT: A Foundation for the NIH Public-Private Partnership That Supports Sharing of Clinical Trial Data for the Development of Improved Imaging Biomarkers in Oncology [O] . Laurent Dercle, Dana E. Connors, Ying Tang, -1

机译：Vol-PACT：NIH公私合作伙伴关系的基础支持共享临床试验数据以开发改进的肿瘤成像生物标志物
7. Vol-PACT: A Foundation for the NIH Public-Private Partnership That Supports Sharing of Clinical Trial Data for the Development of Improved Imaging Biomarkers in Oncology [O] . Laurent Dercle, Dana E. Connors, Ying Tang, 2018

机译：VOL-PAT：NIH公私伙伴关系的基础，支持分享临床试验数据，以便在肿瘤学中改进的成像生物标志物的开发
8. FDA Resource Manual for Clinical Investigations: Regulations, Guidelines, and Other References for Conducting Clinical Trials under Investigational New Drug Applications [R] . Couig, M. P. 1991

机译：FDa临床研究资源手册：在研究性新药申请下进行临床试验的法规，指南和其他参考文献

NIH, FDA Partnership Designed To Improve Clinical Trials

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