title: Regulatory activities to address the needs of older patients.
abstract: At the Drug Information Association (DIA) 49th annual meeting, for the first time regulators (Dr Francesca Cerreta, Dr Robert Temple and Dr Yasuko Asahina) from the three International Conference on Harmonization (ICH) co-sponsor regions came together in a forum to discuss their perspective on how the aging population impacts on drug development and on the design of clinical trials. In 2010, the ICH E7 Guideline (Studies in support of Special Populations: Geriatrics) was revised with the addition of a Questions and Answers document to take into account the rapidly changing world demographics. Regulators from the three ICH regions (Europe, USA and Japan) discuss here how they foresee the application of this guideline, and the impact that this might have on new drug development and clinical trial design. This article aims to summarize the discussions at the session for the benefit of a wider audience.
authors: Francesca Cerreta, Human Medicines Research and Development Support Division, Scientific Advice, London, United Kingdom,Francesca.Cerreta@ema.europa.eu.
authors: F
authors: F
authors: Cerreta
authors: R
authors: R
authors: Temple
authors: Y
authors: Y
authors: Asahina
authors: C
authors: C
authors: Connaire
mesh_terms: D017677:Age Distribution; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D002986:Clinical Trials as Topic / Q000379:methods / Q000639:trends; D003226:Congresses as Topic; D055808:Drug Discovery / Q000379:methods / Q000639:trends; D005060:Europe; D005853:Geriatrics / Q000639:trends*; D006077:Government Agencies / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D017408:Guidelines as Topic; D006301:Health Services Needs and Demand / Q000639:trends*; D006801:Humans; D007391:International Cooperation; D007564:Japan; D014481:United States
references: Fed Regist. 2012 Feb 21;77(34):9948-9
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references: J Nutr Health Aging. 2014 May;18(5):520-3
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