Evidence Library

Title: Patient and public involvement in the early stages of clinical trial development: A systematic cohort investigation
Author: Gamble, C., Dudley, L., Allam, A., Bell, P., Goodare, H., Hanley, B., Preston, J., Walker, A., Williamson, P. and Young, B.
Date Published: 2014
Reference: BMJ Open, 4, e005234
Are service users or carers authors: Yes

Abstract: Aim: To examine the patient and putlic involvement (PPI) within early development of clinical trials. Method: A review of all the documents relating to successful applications for funding of clinical trials by the National Institute for Health Research (NIHR) Health Technology Assessment Programme 2006-10. The documents included outline and full applications and comments from funding Boards. Findings: Out of 110 applications that were included in this study, 29% had PPI in the development of the outline application, 36% in the full application and 48% planned PPI in the running of the trial. There was no evidence of an increase in PPI over time. Blinded trials and trials with placebo arms were more likely to include PPI. Trials recruiting people at the time of diagnosis and trials for surgical interventions were less likely to include PPI. Board feedback rarely referred to PPI. Conclusions: PPI has the greatest potential to make a difference at the earliest stages of trial design but, in practice, involvement at the outline stage of funding applications is low. Funders need to request applicants to provide more detail on PPI at this stage and more evidence of impact is required. Comments on PPI in applications need to give direction on what further PPI is required, rather than simply stating more is needed. Funding for PPI at this stage needs to be made available.

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Categories: health
nature and extent of public involvement in research
journal article

Date Entered: 2014/08/19

Date Edited: 2014/08/19

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