Eligibility determination for clinical trials: development of a case review process at a chiropractic research center.

Robert D Vining,Katherine A Pohlman,Stacie A Salsbury

doi:10.1186/1745-6215-15-406

Abstract

BackgroundSystematic procedures addressing the limitations of eligibility determination are needed to improve the quality of participant recruitment and enrollment in randomized clinical trials. This paper describes an eligibility determination process developed by and in use at a chiropractic research center engaged in community recruitment for clinical trials studying spinal pain conditions.MethodsA team of investigators developed a case review process for application across clinical trials involving chiropractic care. Study personnel representing key study roles including research clinicians, study coordinators, a project manager, and at least one investigator convene in person to determine eligibility for participants following baseline study visit examinations. The research clinician who performed the eligibility examination presents the case and a moderator leads the case review panel through a structured discussion including diagnosis, eligibility criteria, definition review, and clinical precautions. Panel members provide clinical recommendations and determine final eligibility using a structured and moderated voting process.ResultsThrough the case review process for three externally funded clinical trials for participants with neck and low back pain, we presented 697 cases, rendering 472 participants eligible for enrollment and excluding 225 individuals. The most common reasons for case review exclusions across the three trials included neck or back pain not meeting diagnostic classifications, safety concerns related to treatment or testing, referral for further evaluation or treatment, and compliance concerns.ConclusionsThe case review process uses the expertise of study coordinators, research clinicians, project managers, and investigators to render eligibility decisions consistent with study aims for the duration of the trial. This formal eligibility determination process includes steps designed to mitigate the potential for participant misclassification from clinician advocacy or misunderstanding of eligibility criteria, and helps ensure that participants can safely take part in study procedures.Trial registrationThe three trials discussed in this article were registered in ClinicalTrials.gov with the ID numbers of NCT00830596 (27 January 2009), NCT01312233 (04 March 2011), and NCT01765751 (30 May 2012).

Highlights

Systematic procedures addressing the limitations of eligibility determination are needed to improve the quality of participant recruitment and enrollment in randomized clinical trials
In most clinical trials, investigators or their designees determine whether individual participants meet selection criteria, a process vulnerable to selection bias because of subjective interpretations [5] and the personal views of study personnel [6]
Clinical trials overview We developed our case review process for eligibility determination during three separate clinical trials conducted with overlapping enrollment periods over a 5 year timespan

Summary

Introduction

Systematic procedures addressing the limitations of eligibility determination are needed to improve the quality of participant recruitment and enrollment in randomized clinical trials. A challenge for clinical trial researchers is to render eligibility determination with procedures that facilitate consistent decision-making and avoid enrollment error, thereby reducing the opportunity for participant risk [1,7,8]. A 2010 systematic review studying interventions for improving adherence to eligibility criteria in randomized controlled trials did not find any primary publications describing such procedures [5]. There is a need to report eligibility determination procedures designed to address potential limitations and to reduce the need for clinical trial managers to continually re-invent this process, which is necessary when established methods are not yet documented or disseminated broadly [13]

Methods

Results

Discussion

Conclusion