The European Union has worked hard to stimulate interest in conducting clinical trials involving children. At the other end of the scale, though, older people may be missing out.

This was the conclusion drawn from a recent review of the scientific literature by a team from the UK’s Medical Research Council (MRC). They found that potentially beneficial treatments are less likely to be tested in older people, with the result that either therapies given to this population may not have been evaluated in appropriate trials or that older people may not be receiving the right treatment because it has not been tested in the appropriate population.

The MRC review led by Professor Paul Dieppe was part of the European PREDICT project, concerned with increasing the PaRticipation of the ElDerly in Clinical Trials. Supported by the European Union’s Seventh Framework Programme for Research and Technological Development (FP7), PREDICT is being co-ordinated by the Medical Economics and Research Centre in Sheffield, UK (MERCS).

The project, which aims to help enhance the rights of older people and the quality of healthcare for the ageing European population, started in February 2008 and is being carried out in nine European countries: the UK, Spain, the Netherlands, Italy, Poland, Lithuania, Romania, Israel and the Czech Republic.

In the conditions studied by the MRC team, people taking part in clinical trials were generally younger than those typically seen by doctors, MERCS reported. For example, people first diagnosed with heart failure are on average in their mid-seventies, while those participating in clinical trials were in their early sixties. One reason, MERCS said, is that younger people are less likely to have additional health problems and to be taking medicines that may interfere with the experimental treatment.

Trial participation may also be influenced by a family practitioner’s knowledge and opinions on the suitability of a particular clinical trial for their patient and practice, MERCS suggested. Alternatively, older people who are eligible for a trial may have concerns about the risks involved in taking a new treatment, randomisation or informed consent. Or there may just be practical obstacles such as the timing of appointments, access to transport or additional costs.

The MRC team did find studies that tried to address some of these difficulties. For example, initial contact with a general practitioner helped to explain the need for a clinical trial, while a brief educational and counselling session threw some light on the consent process. Conducting assessments and measurements at the patient’s home, rather than at an outpatient clinic, seemed to help people stay with a trial once they had joined it.

For the next stage of the PREDICT project, views on these issues will be sought from health professionals and older patients in all of the participating countries. The findings will be used to draft a charter for older people in clinical trials, which is scheduled for launch in February 2010.