The views of older people and carers on participation in clinical trials: the PREDICT Study

Concern over the inappropriate exclusion of older people from clinical trials is longstanding. The PREDICT study used mixed methods to investigate the extent of this exclusion and to explore the views of those directly involved. This paper reports findings from that aspect of the study investigating the views of older people and carers. Drawing on findings from earlier stages in the study, a structured interview schedule was developed to form the basis of focus group discussions. Groups were held across nine countries: the Czech Republic, Israel, Italy, Lithuania, Holland, Poland, Romania, Spain and the UK (n = 42). Discussants were those living with conditions commonly affecting older people: hypertension, cancer, dementia, heart failure, stroke and depression (n = 285). Data were analyzed for differences and commonalities within and between groups. Issues raised fell into four themes: ageism, both within society and amongst clinicians and researchers; advantages and disadvantages to participation; the relationship between the participant and their clinician/research team; and practical features to support participation. Findings confirm that older people and carers see chronological age as an insufficient reason for exclusion from trials and view such exclusion as age discrimination. They point to the complex relationship between healthcare professionals and trial participants and identify the need for cultural and generational sensitivity in trial design, as well as the importance of considering adaptations to meet special needs. Finally, they identify the need for quality of life to be included as an outcome measure in such research and emphasize the importance of including lay perspectives in health research design generally.