(duplicate) Understanding patient recruitment into Surgical Clinical Trials
Research type
Research Study
Full title
Understanding patient recruitment into Surgical Clinical Trials
IRAS ID
170923
Contact name
Erik Mayer
Contact email
Sponsor organisation
Christine Buicke
Clinicaltrials.gov Identifier
PS2318, BRC Project Number
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
Patient recruitment for randomised controlled trials (RCTs) is a challenging procedure especially when competing biases impact on the ability of both patients and/or recruiter to truly accept clinical equipoise. This was particularly pertinent to the CRUK-funded LopeRA study, that originated from the Department of Surgery & Cancer, Imperial College London, for which recruitment rates were below target. Reported reasons for difficulty of recruitment included both recruiter barriers and patient preferences for specific treatments.
Evidence suggests that qualitative research can play a role in improving our understanding of recruitment-related problems within RCTs – thus ultimately helping improve the conduct of RCTs and increase recruitment in the future. Within the LopeRA trial a qualitative study with those involved in recruiting patients identified important factors that contributed to the lower than expected recruitment rate. Some of these, such as the inability of clinicians involved to maintain clinical equipoise, have been reported previously and can be avoided by using research nurses to present information in a balanced manner. Patient-related barriers, reported by the clinicians, however were unique to LopeRA and it being a ‘pure’ surgical RCT comparing surgical approaches for the same operation, including surgical technology.
The primary objective of this qualitative study will be to identify patient factors, as reported by patients themselves, that could contribute to the success, or not, of a surgical RCT comparing treatment modalities. Information pertaining to recruitment to surgical RCTs in general will be obtained and subsequently the recommendations from this study, including the generation of a screening survey, can be extended to predict the probable success of future surgical RCTs.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0211
Date of REC Opinion
24 Apr 2015
REC opinion
Favourable Opinion