EFGCP Guidelines on Medical Research
for and with Older People in Europe
Dear EFGCP Member / Dear Colleague,
On behalf of the EFGCP Geriatric Medicines Working Party (GMWP), we are glad to present the finalised ‘EFGCP Guidelines on Medical Research for and with Older People in Europe’. In Europe the population is ageing rapidly. Older people are taking many medicinal products daily and these may not necessarily be suitable for them. Publications show that older patients are underrepresented in clinical trials, especially those over 75 years, with multiple co-morbidities, concomitant treatments and/or frailty. This document provides a summary of recommendations on ethical aspects of clinical trials with older people, who may in some cases be considered a vulnerable patient population. The GMWP has developed this guidance to promote such research and to support health care professionals in their efforts.
This document is the result of 2 years of intensive work based on several workshops organised by the EFGCP GMWP. It started when the GMWP invited J-M. Vetel and F. Hirsch to present a first draft along the same line as the European Medicines Agency (EMA) paediatrics guidelines with the goal to foster ethical research in this neglected area. The overall principles and key elements of this guidance were further elaborated, discussed and revised by the GMWP in the following years and presented at the EMA workshop on Medicines for Older People in March 2012. Following a multi-stakeholder public consultation, the GMWP received many thoughtful comments from academia, investigators, regulators, patient advocacy groups and pharmaceutical industry. The GMWP met twice to review and incorporate in a cohesive manner as many comments as possible into the final text. This was then shared with all those who had contributed and/or reviewed the draft who in turn gave their permission to have their names mentioned.
A short version of this document is now published on line on the JNHA website: http://link.springer.com/article/10.1007/s12603-013-0340-0
(DIENER L. HUGONOT-DIENER L., ALVINO S., BAEYENS JP., BONE M.P. CHIRITA D., HUSSON J.M., MAMAN M., PIETTE F., TINKER A., VON RAISON F. Guidance synthesis. Medical research for and with older people in europe: proposed ethical guidance for good clinical practice: ethical considerations. J Nutr Health Aging.2013.poi)
The long version is available for public download below clicking on the pdf icon.
It is the hope of the GMWP that these guidelines may become European, bearing in mind that the population included in clinical research should be representative of the future consumers of the tested drugs.
on behalf of the EFGCP GMWP
L. Hugonot-Diener & F. Von Raison
Co-Chairpersons of the GMWP
EFGCP Guidelines on Medical Research for and with Older People in Europe (2013)