A charter supporting the rights of older people in clinical trials has been launched as part of the European PREDICT project co-ordinated by the Medical Economics and Research Centre (MERCS) in Sheffield, UK.

The argument is that too often clinical trials for conditions prevalent in older people, such as heart failure, hypertension, Alzheimer’s disease, depression or colorectal cancer, are not sufficiently representative of this population.

For example, systematic reviews have found that 44% of patients with a first diagnosis of hypertension are aged over 70 years, while the mean age of patients in trials for hypertension is 63.5 years.

Study results cannot always be extrapolated from younger participants, since they need to take into account issues specific to older patients, such as changes in metabolism, multiple chronic conditions and the use of several drugs in parallel.

This not only leaves older people short of therapies fully tailored to their needs but makes it difficult for doctors to know which drugs will be safe and effective in older patients.

In surveys conducted for the PREDICT project, more than 90% of geriatricians, general practitioners, nurses, ethicists, pharmacists and trialists agreed that under-representation of older people in clinical studies caused difficulties for both prescribers and patients.

Supported by the European Union’s Seventh Framework Programme for Research and Technological Development (FP7), PREDICT is concerned with increasing the PaRticipation of the ElDerly in Clinical Trials. The project 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.

As MERCS has noted, one reason older people are excluded from clinical trials is that they present more of a challenge. Younger people are less likely to have additional health problems and to be taking medicines that may interfere with the study treatment.

At the same time, older people who are eligible for trials may have concerns about the risks involved, randomisation or informed consent. There may also be practical obstacles such as the timing of appointments, access to transport or additional costs.