Objective 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. Fields of science medical and health sciencesclinical medicinegerontology Keywords ageism clinical trials elderly ethics geriatrics poly-pharmacy qualitative research systematic review Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH-2007-2.2.2-4 - Increasing the participation of elderly in clinical trials Call for proposal FP7-HEALTH-2007-A See other projects for this call Funding Scheme CSA-SA - Support actions Coordinator MEDICAL ECONOMICS AND RESEARCH CENTRE, SHEFFIELD EU contribution € 201 658,60 Address ROTHERHAM GENERAL HOSPITAL, WOODSIDE, MOORGATE ROAD OAKWOOD S60 2UD ROTHERHAM United Kingdom See on map Activity type Research Organisations Administrative Contact David Edbrooke (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (10) Sort alphabetically Sort by EU Contribution Expand all Collapse all UNIVERSITA DEGLI STUDI DI PERUGIA Italy EU contribution € 69 287,85 Address PIAZZA DELL UNIVERSITA 1 06123 Perugia See on map Region Centro (IT) Umbria Perugia Activity type Higher or Secondary Education Establishments Administrative Contact Roberto Quartesan (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITY OF KEELE ROYAL CHARTER United Kingdom EU contribution € 101 248,92 Address KEELE UNIVERSITY FINANCE DPT ST5 5BG Keele See on map Region West Midlands (England) Shropshire and Staffordshire Staffordshire CC Activity type Higher or Secondary Education Establishments Administrative Contact Judith Mary Garside (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CORPORACIO SANITARIA PARC TAULI DE SABADELL Spain EU contribution € 45 886,95 Address PARC TAULI S/N 08208 Sabadell See on map Region Este Cataluña Barcelona Activity type Research Organisations Administrative Contact Joaquim Oristrell (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIWERSYTET JAGIELLONSKI COLLEGIUM MEDICUM Poland EU contribution € 34 638,04 Address Sw Anny, 12 31008 KRAKOW See on map Activity type Higher or Secondary Education Establishments Administrative Contact Marcin Jedrychowski (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data KAUNO MEDICINOS UNIVERSITETAS Lithuania EU contribution € 34 039,45 Address A MICKEVICIAUS G 9 3000 KAUNAS See on map Activity type Higher or Secondary Education Establishments Administrative Contact Vita Lesauskaite (Prof.) Links Contact the organisation Opens in new window Total cost No data ANA ASLAN INSTITUTE OF GERONTOLOGY AND GERIATRICS Romania EU contribution € 35 158,06 Address STRADA MANASTIREA CALDARUSANI 9 11241 BUCHAREST See on map Activity type Higher or Secondary Education Establishments Administrative Contact Gabriel-Ioan Prada (Prof.) Links Contact the organisation Opens in new window Total cost No data BEN-GURION UNIVERSITY OF THE NEGEV Israel EU contribution € 44 096,84 Address . 84105 Beer Sheva See on map Activity type Higher or Secondary Education Establishments Administrative Contact Daphna Tripto (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERZITA KARLOVA Czechia EU contribution € 59 591,51 Address OVOCNY TRH 560/5 116 36 Praha 1 See on map Region Česko Praha Hlavní město Praha Activity type Higher or Secondary Education Establishments Administrative Contact Kristyna Matejkova (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data MEDICAL RESEARCH COUNCIL United Kingdom EU contribution € 56 000,37 Address 20 Park Crescent W1B 1AL LONDON See on map Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Dot Knight (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data VERENIGING VOOR CHRISTELIJK HOGER ONDERWIJS WETENSCHAPPELIJK ONDERZOEK EN PATIENTENZORG Netherlands EU contribution € 68 440,41 Address De Boelelaan 1105 1081 HV Amsterdam See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Higher or Secondary Education Establishments Administrative Contact Miel Ribbe (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data