EU researchers tackle age discrimination in clinical trials

Drug consumption is high among the elderly for obvious reasons. The question, however, is, why is this group excluded from clinical drug trials? The EU-funded PREDICT ('Increasing the participation of the elderly in clinical trials') project is determined to find the answer, a...

Drug consumption is high among the elderly for obvious reasons. The question, however, is, why is this group excluded from clinical drug trials? The EU-funded PREDICT ('Increasing the participation of the elderly in clinical trials') project is determined to find the answer, and a charter that opposes discrimination against the elderly in clinical trials is underway. Funding for the project totals more than EUR 750,000 under the Health Theme of the Seventh Framework Programme (FP7).

Health experts say validation of drugs efficacy and safety is important, particularly since the European population is ageing increasingly. Clinical drug trials should take into account critical factors such as their effect on the elderly in terms of altered metabolism, for instance.

Coordinated by the Medical Economics and Research Centre in the UK, the PREDICT project partners highlight how results from trials conducted on the younger population cannot always be extrapolated to the older population. They believe that the elderly should be provided with drugs that have been tested for efficacy and safety for their age group.

The 11-strong consortium is currently evaluating the extent to which the elderly were excluded from such trials. The researchers have found, for example, that the average age of patients in clinical trials of treatments for high blood pressure is 63, but 44% of patients are aged 70 plus when the initial diagnosis for this condition is made.

For the purposes of this study, health experts in 9 countries were interviewed and 50 focus groups were conducted with the elderly and their carers. Based on their findings, both patients and doctors would welcome the inclusion of this age group in clinical trials.

'If treatments are not evaluated for elderly people it is difficult for doctors to balance the risks and benefits,' the BBC quoted Dr Gary Mills, director of the Medical Economics and Research Centre.

According to Dr Mills, practical alternatives may have to be considered when older people are to participate in clinical trials. For instance, researchers conducting the trials may have to take the testing site to the participants (i.e. visit their homes) rather than bring the participants to the actual testing centre.

The PREDICT project has garnered support from the British Geriatrics Society whose representative Professor David Oliver pointed out that the underrepresentation of the elderly in clinical trials was a 'serious problem'. According to Professor Oliver, 'doctors try to practise evidence-based medicine, but this is not possible if there are not enough elderly people in the trials.' Testing on younger people may be easier, but the results may have a significant impact on the older population, he added.

'They [the elderly] are less likely than younger people to have clinical trial evidence on which to make decisions about the risk and benefits of drugs and other treatments,' the Financial Times quoted Professor Peter Crome, the former president of the British Geriatrics Society, as saying, adding that this is a form of age discrimination.

PREDICT brings together researchers from the Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain and the UK.