"AIM. To investigate the 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. Clinical trials need to take into account the relevant issues of this population, i.e. changed metabolism, multiple chronic conditions and poly-pharmacy. To examine this issue and effect a paradigm shift it is necessary to target gatekeepers and stakeholders of clinical trials. METHODS. The project will be coordinated by the Medical Economics and Research Centre, Sheffield, with guidance from the Centre for Interdisciplinary Research on Ageing at Keele University, UK. The 5 work packages (WP) will be carried out by a multi-disciplinary team of highly qualified experts in Geriatrics, Gerontology and social sciences. WP1 will involve a systematic review of the literature and review of ongoing clinical trials to assess the extent of exclusion of the elderly. Based on these findings WP2 and WP 3 will investigate why the elderly are underrepresented in clinical trials and what can be done to improve their participation. This will be carried out in 9 countries: UK, Spain, Holland, Italy, Poland, Lithuania, Romania, Israel and the Czech Republic. WP2 will research the views of health professionals and ethicists using structured questionnaires. WP3 will explore the perceptions of older patients and carers using a focus group methodology. For WP4, the recommendations from WP2 and WP3 will be used to develop a charter for the elderly in clinical trials. WP5 will disseminate and implement the findings. CONCLUSION. PREDICT will promote the inclusion of the elderly in clinical trials in Europe. This project will facilitate the improvement of the rights of older people and the quality of health care for the ageing population."