Aim To investigate reasons for the exclusion of the elderly in clinical trials and to provide solutions for this problem
Introduction
Although the elderly account for high drug consumption, they are underrepresented in
clinical trials. With an increasingly ageing European population it is essential to demonstrate the efficacy and safety of drugs and treatments. Clinical trials need to take into account the relevant issues of this
population, i.e. changed metabolism, multiple chronic conditions and polypharmacy
To examine this issue and to effect a paradigm shift the PREDICT consortium intends to
engage both the stakeholders of older people's health and the gatekeepers of clinical trials.
The PREDICT consortium, includes key European geriatricians, who have all too
frequently found themselves in a situation where they are unable to prescribe the best course of treatment with the weight of scientific evidence behind them, due to insufficient evidence from clinical trials. This
is particularly problematic with very old patients. In practice, clinicians are left to extrapolate from studies of younger, healthier subjects - a practice fraught with difficulty. An analogous problem has occurred
in the paediatric context but research in this domain, is much better developed than for the frail older person.
The PREDICT project, which started in February 2008, is due to last for 27 months.is
supported by the European Union, FP7 Health research, grant number HEALTH-F4-2008-201917