The PREDICT Study. Patients and carers views of older peoples participation in clinical trials

Bernadette Bartlam, Frank Lally, Peter Crome, Eva Topinkova, A Mark Clarfield, Antonio Cherubini, Vita Lesauskaite, Cees Hertogh, Katarzyna Szczerbińska, Gabriel I. Prada, Albert Farre, Judith Sinclair-Cohen, Gary Mills

Research output: Contribution to journalMeeting abstractpeer-review

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Abstract

Introduction: PREDICT was a two year study across nine European countries examining the continuing exclusion of older people from clinical trials. We present the views of older
people and carers on this issue obtained from a series of focus groups.

Method: A total of 42 focus groups took place (285 individuals aged 65+) across 9 partner countries. Participants, including their carers, were drawn from groups living with
conditions most commonly affecting older people, i.e. high blood pressure, cancer (colon), early onset dementia, heart failure and depression.

Discussions: were standardised using a piloted semi-structured interview schedule focussing on understanding of clinical trials, whether older people should be included
and under what conditions. Sessions were recorded and transcripts analysed for responses. (to the questions and emerging themes) The data were explored for differences and commonalities within groups, across groups and across countries.

Results: Consistent findings emerged across the partner countries which highlighted two major themes: ageism in trial design and recruitment, and a lack of information, both on the importance of trials and on the need to include older people. Participants considered that older people had the right to be included in such research and that the existing
lack of inclusion raised questions about the scientific merit of results.

Conclusions: The findings of this study echo those reported by professionals (Crome et al. JAGS 2010, 58: S83-S84) and from the wider literature. There is support for the greater involvement of older people in clinical trials although adaptation to meet special needs may be necessary. The themes that emerged from the study have been incorporated into the European Charter on the rights of older people.
Original languageEnglish
Pages (from-to)i73
Number of pages1
JournalAge and Ageing
Volume40
Issue numberSuppl 1
DOIs
Publication statusPublished - 1 Jan 2011

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