Do Screening Trial Recruitment Logs Accurately Reflect the Eligibility Criteria of a Given Clinical Trial? Early Lessons from the RAVES 0803 Trial

作者：Sundaresan P^*; Turner S; Kneebone A; Pearse M; Fraser Browne C; Woo H H

来源：Clinical Oncology, 2014, 26(6): 348-352.

DOI：10.1016/j.clon.2014.02.012

• Eligibility criteria
• generalisability
• randomised controlled trial
• screening log
• trial recruitment

Aims: Maintaining clinical trial screening logs and reporting data from such logs are given importance due to the relevance of a trial's patient population to the generalisability of its findings. However, screening logs may not always reflect a clinical trial's true target population. The aim of the present study was to define and compare 'apparent recruitment' to a trial as captured in a clinical trial screening log with 'true recruitment', which considers all potentially eligible patients. The Trans Tasman Radiation Oncology Group (TROG) 0803 RAVES clinical trial was used to examine the above.
Materials and methods: A prospective, surgical database was interrogated for the 12 month period to identify patients potentially eligible for the TROG 0803 RAVES trial. Information on whether patients were referred to a RAVES trial recruitment site and reasons for non-referral were obtained.
Results: Of 92 men undergoing radical prostatectomy, 28 met the RAVES clinical trial eligibility criteria. Fifteen of the 28 eligible men were assessed at a RAVES trial site, with five being ultimately recruited to RAVES (33% 'apparent recruitment fraction' as captured by the site's trial screening log). The 'true recruitment fraction' was 5/28 (18%).
Conclusion: Screening logs at a recruiting trial site may underestimate the trial's target population and overestimate recruitment. Only a subpopulation of all eligible patients may be captured in trial screening logs and subsequently reported on. This may affect the generalisability of the trial's reported findings.

• 出版日期2014-6