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Increasing the PaRticipation of the ElDerly in Clinical Trials

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.

Field of science

  • /social sciences
  • /medical and health sciences/clinical medicine/gerontology

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
Address
Rotherham General Hospital, Woodside, Moorgate Road Oakwood
S60 2UD Rotherham
United Kingdom
Activity type
Research Organisations
EU contribution
€ 201 658,60
Administrative Contact
David Edbrooke (Prof.)

Participants (10)

UNIVERSITA DEGLI STUDI DI PERUGIA
Italy
EU contribution
€ 69 287,85
Address
Piazza Dell Universita 1
06123 Perugia
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Roberto Quartesan (Prof.)
UNIVERSITY OF KEELE ROYAL CHARTER
United Kingdom
EU contribution
€ 101 248,92
Address
Keele University Finance Dpt
ST5 5BG Keele
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Judith Mary Garside (Ms.)
CORPORACIO SANITARIA PARC TAULI DE SABADELL
Spain
EU contribution
€ 45 886,95
Address
Parc Tauli S/n
08208 Sabadell
Activity type
Research Organisations
Administrative Contact
Joaquim Oristrell (Dr.)
UNIWERSYTET JAGIELLONSKI
Poland
EU contribution
€ 34 638,04
Address
Ul. Golebia 24
31 007 Krakow
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Marcin Jedrychowski (Mr.)
KAUNO MEDICINOS UNIVERSITETAS
Lithuania
EU contribution
€ 34 039,45
Address
A Mickeviciaus G 9
3000 Kaunas
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Vita Lesauskaite (Prof.)
ANA ASLAN INSTITUTE OF GERONTOLOGY AND GERIATRICS
Romania
EU contribution
€ 35 158,06
Address
Strada Manastirea Caldarusani 9
11241 Bucharest
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gabriel-Ioan Prada (Prof.)
BEN-GURION UNIVERSITY OF THE NEGEV
Israel
EU contribution
€ 44 096,84
Address
.
84105 Beer Sheva
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Daphna Tripto (Ms.)
UNIVERZITA KARLOVA
Czechia
EU contribution
€ 59 591,51
Address
Ovocny Trh 560/5
116 36 Praha 1
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kristyna Matejkova (Ms.)
MEDICAL RESEARCH COUNCIL
United Kingdom
EU contribution
€ 56 000,37
Address
North Star Avenue Polaris House 2 Floor David Phillips Building
SN2 1FL Swindon
Activity type
Research Organisations
Administrative Contact
Dot Knight (Ms.)
VERENIGING VOOR CHRISTELIJK HOGER ONDERWIJS WETENSCHAPPELIJK ONDERZOEK EN PATIENTENZORG
Netherlands
EU contribution
€ 68 440,41
Address
De Boelelaan 1105
1081 HV Amsterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Miel Ribbe (Prof.)