Pressure Mounts to Involve Elderly

A European initiative designed to increase the participation of the elderly in clinical trials is starting to gather momentum.

The PREDICT project began in February 2008. Funded by the European Union and coordinated by the Medical Economics and Research Centre in Sheffield, UK, its members consist mainly of European geriatricians who are concerned that they are often unable to prescribe the best course of treatment due to insufficient scientific evidence from clinical trials.

Clinicians are left to extrapolate from studies of younger, healthier subjects—a practice fraught with difficulty, they warn.

At the 19th World Congress of Gerontology and Geriatrics in Paris in July, the group is organizing a symposium about older people in clinical trials. Its initial data will be presented, and discussion will focus on four key questions: What evidence is there that the elderly have been excluded? Are current trials including the elderly? What are the opinions of clinicians, other professionals, patients, and caregivers? Is a charter needed for the elderly?

Lacking evidence

"The elderly consume about 40% of total medication, but they are under-represented in clinical trials," said project manager Judith Sinclair-Cohen, BDS, MSc. "With an increasingly ageing European population, it is essential to demonstrate the efficacy and safety of drugs and treatments in older people, who have different pharmacokinetics to their younger peers."

Clinical trials must take into account the relevant issues of this population, including changed metabolism, multiple chronic conditions, and polypharmacy, she noted