New Guidance on Studies Involving Geriatric Patients Released by FDA

The US Food and Drug Administration (FDA) released a final guidance on 21 February that provides insight into how sponsors should conduct clinical trials when their studies are likely to involve elderly patients.

FDA's Guidance for Industry - E7 Studies in Support of Special Populations: Geriatrics conforms to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document of the same name.

The final guidance describes the rationale for including geriatric patients in clinical studies, how to adequately represent geriatric patients in clinical studies, special health and data considerations that must be taken in to account, and age-related pharmacokinetic differences.

• FDA - Guidance for Industry - E7 Studies in Support of Special Populations: Geriatrics
• FDA - International Conference on Harmonisation; Guidance on E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers; Availability