title: [Development of a charter for older people in clinical trials: PREDICT].
abstract: Recent national guidelines on dementia and stroke demonstrate an unmistakable age gap: although both conditions are very prevalent in older people, the evidence supporting these guidelines is mainly drawn from research performed in younger patients. These examples are illustrative of a wider problem. When it comes to drug trials the underrepresentation of elderly people in clinical studies can have devastating effects. Under- and overtreatment as well as 'off label' prescription are common in this age group and they are overrepresented when it comes to negative treatment outcomes and adverse effects. Awareness of the pervasiveness of these problems is growing and there are several initiatives to improve medication safety in elderly patients. However, most of these focus on medication that is already certified, leaving the principle cause of the problem, namely the exclusion of the elderly from clinical trials, untouched. This issue is now being tackled by a European research consortium called PREDICT (Increasing the PaRticipation of the ElDerly In Clinical Trials). Using a multi-method approach this project assesses the participation of older people in recent and ongoing trials, surveys their views on facilitators and barriers to participation, as well as those of health professionals and ethicists and aims to use these findings to draft a charter for the rights of elderly people in clinical trials.
authors.forename: C M P M
authors.initials: CM
authors.lastname: Hertogh
mesh_terms: D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D032984:Ethics, Research; D006801:Humans; D010358:Patient Participation; D018579:Patient Selection