Strategies and Challenges in Clinical Trials Targeting Human Aging.
Strategies and Challenges in Clinical Trials Targeting Human Aging.
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DOI：
10.1093/gerona/glw149
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发表时间：
2016-11
期刊：
影响因子：
--
通讯作者：
Barzilai N
中科院分区：
文献类型：
--
作者：
Newman JC;Milman S;Hashmi SK;Austad SN;Kirkland JL;Halter JB;Barzilai N
针对基本老龄化过程的干预措施有可能改变人类的健康和保健。各种候选药物已经从可能针对衰老过程的基础和翻译研究中涌现出来。其中一些药物已经在临床上用于其他目的，如二甲双胍和雷帕霉素。然而，设计临床试验来测试针对衰老过程的干预措施会带来一系列独特的挑战。本文总结了由美国国立卫生研究院资助的老年科学网络协调的一次国际会议的结果，该会议旨在推进开发翻译管道的目标，以将候选化合物通过临床试验并最终投入使用。我们回顾了一些已经在临床使用的药物可能针对基本衰老过程的证据。我们讨论了临床试验的设计原则，以在人体上测试这种干预措施，包括研究人群、干预措施和结果。作为例子，我们提供了几个以健康跨度(延迟多病和功能衰退)和恢复力(对急性健康压力的反应或恢复)概念为中心的潜在临床试验的情景。最后，我们描述了这一讨论如何帮助设计拟议的使用二甲双胍的靶向衰老研究。
Interventions that target fundamental aging processes have the potential to transform human health and health care. A variety of candidate drugs have emerged from basic and translational research that may target aging processes. Some of these drugs are already in clinical use for other purposes, such as metformin and rapamycin. However, designing clinical trials to test interventions that target the aging process poses a unique set of challenges. This paper summarizes the outcomes of an international meeting co-ordinated by the NIH-funded Geroscience Network to further the goal of developing a translational pipeline to move candidate compounds through clinical trials and ultimately into use. We review the evidence that some drugs already in clinical use may target fundamental aging processes. We discuss the design principles of clinical trials to test such interventions in humans, including study populations, interventions, and outcomes. As examples, we offer several scenarios for potential clinical trials centered on the concepts of health span (delayed multimorbidity and functional decline) and resilience (response to or recovery from an acute health stress). Finally, we describe how this discussion helped inform the design of the proposed Targeting Aging with Metformin study.
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影响因子：
168.9
作者：
Burn, John;Gerdes, Anne-Marie;Macrae, Finlay;Mecklin, Jukka-Pekka;Moeslein, Gabriela;Olschwang, Sylviane;Eccles, Diane;Evans, D. Gareth;Maher, Eamonn R.;Bertario, Lucio;Bisgaard, Marie-Luise;Dunlop, Malcolm G.;Ho, Judy W. C.;Hodgson, Shirley V.;Lindblom, Annika;Lubinski, Jan;Morrison, Patrick J.;Murday, Victoria;Ramesar, Raj;Side, Lucy;Scott, Rodney J.;Thomas, Huw J. W.;Vasen, Hans F.;Barker, Gail;Crawford, Gillian;Elliott, Faye;Movahedi, Mohammad;Pylvanainen, Kirsi;Wijnen, Juul T.;Fodde, Riccardo;Lynch, Henry T.;Mathers, John C.;Bishop, D. Timothy
通讯作者：
Bishop, D. Timothy
影响因子：
4
作者：
Davies, Neil M.;Kehoe, Patrick G.;Martin, Richard M.
通讯作者：
Martin, Richard M.
DOI：
10.1196/annals.1347.008
发表时间：
2005-01-01
期刊：
FUTURE OF HORMONE THERAPY: WHAT BASIC SCIENCE AND CLINICAL STUDIES TEACH US
影响因子：
--
作者：
Dykens, JA;Moos, WH;Howell, N
通讯作者：
Howell, N
影响因子：
--
作者：
Basso, N;Paglia, N;Inserra, F
通讯作者：
Inserra, F
DOI：
10.1152/ajpheart.00393.2007
发表时间：
2007-09-01
影响因子：
4.8
作者：
Basso, Nidia;Cini, Rosa;Inserra, Felipe
通讯作者：
Inserra, Felipe