STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS

STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS
ICH Harmonised Tripartite Guideline

1. STATEMENT OF PURPOSE
It is important to ensure that clinical testing programs are carried out according to harmonised guidelines based on agreed ethical and scientific principles so that the international development of valuable innovative drugs is achieved with maximum efficiency.

Harmonisation in relation to medicines for geriatric populations is an important issue because the total population of the elderly will increase significantly in the coming years in Europe, Japan and the USA. The use of drugs in this population requires special consideration due to the frequent occurrence of underlying diseases, concomitant drug therapy and the consequent risk of drug interaction.

2. GENERAL PRINCIPLE
Drugs should be studied in all age groups, including the elderly, for which they will have significant utility. Patients entering clinical trials should be reasonably representative of the population that will be later treated by the drug.

3. SCOPE OF GUIDELINE
This guideline is directed principally toward new Molecular Entities that are likely to have significant use in the elderly, either because the disease intended to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or because the population to be treated is known to include substantial numbers of geriatric patients (e.g., hypertension).

The guideline applies also to new formulations and new combinations of established
medicinal products when there is specific reason to expect that conditions common in the elderly (e.g., renal or hepatic impairment, impaired cardiac function, concomitant illnesses or concomitant medications) are likely to be encountered and are not already dealt with in current labelling. It likewise applies when the new formulation or new combination is likely to alter the geriatric patient's response (with regard to either safety/ tolerability or efficacy) compared with that of the non-geriatric patient in a way different from previous formulations.

The guideline also applies to new uses that have significant potential applicability to the elderly.

open here to see the full-text (pdf):
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002875.pdf