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. 2014 Jul 23;4(7):e005234.
doi: 10.1136/bmjopen-2014-005234.

Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation

Carrol Gamble  1 , Louise Dudley  1 , Alison Allam  2 , Philip Bell  3 , Heather Goodare  4 , Bec Hanley  5 , Jennifer Preston  6 , Alison Walker  4 , Paula Williamson  1 , Bridget Young  7
Affiliations

Patient and public involvement in the early stages of clinical trial development: a systematic cohort investigation

Carrol Gamble et al. BMJ Open. .

Abstract

Background: Randomised controlled trials (RCTs) are considered particularly likely to benefit from patient and public involvement (PPI). Decisions made by professional researchers at the outset may go on to have a significant impact on the potential for PPI contributions.

Objective: To increase knowledge of PPI within the early development of RCTs by systematically describing the reported level, nature and acceptability of proposed PPI to the funders.

Methods: Documentation from the outline application process for all RCTs that received funding from the Health Technology Assessment (HTA) Programme 2006-2010 was requested. For each application, data were extracted on trial characteristics, references to PPI in the development of the outline application and funding Board feedback, and plans for PPI in the full application and after the trial was funded.

Results: 110 applications were eligible with outline applications available for 90 (82%). The cohort covered a wide range of interventions and conditions. 54% (49/90) provided some information about PPI. 26 (28.9%) indicated PPI within the development of the outline application itself; 32 (35.6%) planned involvement in the full application and 43 (48%) once the trial was funded. Recruitment at diagnosis and surgical interventions were less likely to describe PPI. Blinded trials and trials in which participants may receive placebo only, more frequently described PPI activity. The HTA commissioning Board feedback rarely referred to PPI.

Conclusions: Incorporation of PPI within the development of the outline application or specification of plans for future involvement was low. Funder requests for applicants to provide information on PPI and justification for its absence should be welcomed but further research is needed to identify the impact of this on its contributions to research. Comments on PPI by reviewers should be directional rather than state that an increase is required. Challenges facing applicants in initiating PPI prior to funding need to be addressed.

Keywords: Consumer participation; HEALTH SERVICES ADMINISTRATION & MANAGEMENT; STATISTICS & RESEARCH METHODS.

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Figures

Figure 1
Figure 1
Number of outline applications by the year in which the application was made (PPI, patient and public involvement).
Figure 2
Figure 2
Percentage of outline applications containing patient and public involvement (PPI) details by the year in which the application was made. The number of trials included within each year is indicated at the top of each bar.
Figure 3
Figure 3
Cumulative percentages of outline applications by disease/condition (PPI, patient and public involvement).
See this image and copyright information in PMC

References

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