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Clinical trials should involve the elderly more, say experts

By Natalie Morrison , 19-Sep-2012
Last updated on 19-Sep-2012 at 17:10 GMT

Clinical trials must involve more elderly patients

Geriatric patients are left out of trials too often say experts who want researchers to 'open their minds' to the benefits of recruiting the elderly.

Last week, speakers at the annual congress of the German Society of Gerontology and Geriatrics (DGG) said problems like mobility, compliance and difficulties presented by the fact elderly people often take other meds – known as polypharmacy – leave researchers unwilling to collect data on the subset.

However with medicine regimes for the elderly often unsuitable, the general view was that the age group must be taken into consideration more often during research.

Congress speaker and director of pharmaceutical business development at Capsugel, Sven Stegemann, told Outsourcing-Pharma.com: “Prescribing to older adults is a challenging task as the metabolism of the drug as well as the response to the drug might vary from younger people, especially when the patient suffers from various diseases and takes several drugs.

“However, as they are for most of the drugs developed today the major user group, they should be included and represented in clinical trials to the extent that is representative for real life.”

He added that non-compliance is a big threat in clinical trials because it will significantly impact the read out of the results.

Regulatory change

Manfred Gogol, a geriatrician and former president of the German Society of Gerontology and Geriatrics – who also spoke at the congress in Bonn – told us that confusing regulations over elderly participants is also off-putting to researchers.

“They are right not to treat as recommended because research results and guideline recommendations usually do not address the situation of patients with complete and lots of morbidity – so-called multimorbidity,” he said.

He added that researchers must “open their minds” to geriatric psychological and social factors which could hinder them getting to trial sites, and complying with the set regimen.

However there is hope for the future, with both Gogol and Stegemann cheering the European Medicine Agency’s (EMA) recent initiative the ‘Geriatric Medicine Road Map 2015’ .

The aims include more detailed assessment of clinical data relating to geriatric populations and a greater focus on involving older patients in trials.

Gogol said: “They will not pass drugs which are not tested in geriatric patients.”

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