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.