Abstract

BackgroundMedical progress depends on the evaluation of new diagnostic and therapeutic interventions within clinical trials. Clinical trial recruitment support systems (CTRSS) aim to improve the recruitment process in terms of effectiveness and efficiency.ObjectiveThe goals were to (1) create an overview of all CTRSS reported until the end of 2013, (2) find and describe similarities in design, (3) theorize on the reasons for different approaches, and (4) examine whether projects were able to illustrate the impact of CTRSS.MethodsWe searched PubMed titles, abstracts, and keywords for terms related to CTRSS research. Query results were classified according to clinical context, workflow integration, knowledge and data sources, reasoning algorithm, and outcome.ResultsA total of 101 papers on 79 different systems were found. Most lacked details in one or more categories. There were 3 different CTRSS that dominated: (1) systems for the retrospective identification of trial participants based on existing clinical data, typically through Structured Query Language (SQL) queries on relational databases, (2) systems that monitored the appearance of a key event of an existing health information technology component in which the occurrence of the event caused a comprehensive eligibility test for a patient or was directly communicated to the researcher, and (3) independent systems that required a user to enter patient data into an interface to trigger an eligibility assessment. Although the treating physician was required to act for the patient in older systems, it is now becoming increasingly popular to offer this possibility directly to the patient.ConclusionsMany CTRSS are designed to fit the existing infrastructure of a clinical care provider or the particularities of a trial. We conclude that the success of a CTRSS depends more on its successful workflow integration than on sophisticated reasoning and data processing algorithms. Furthermore, some of the most recent literature suggest that an increase in recruited patients and improvements in recruitment efficiency can be expected, although the former will depend on the error rate of the recruitment process being replaced. Finally, to increase the quality of future CTRSS reports, we propose a checklist of items that should be included.

Highlights

  • Medical progress depends on the evaluation of new diagnostic and therapeutic interventions within clinical trials

  • We suggested that the introduction of a Clinical trial recruitment support systems (CTRSS) can be motivated by 3 expectations: (1) an increase in the number of participants for a given clinical trial or a set of trials, (2) a reduction of trial costs through decreased screening costs, and (3) the guarantee to select a representative set of patients

  • Many authors do not elaborate on the shortcomings of the manual recruitment process that led to the development of their CTRSS

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Summary

Introduction

Medical progress depends on the evaluation of new diagnostic and therapeutic interventions within clinical trials. The main stakeholders in the recruitment process are the patient, the treating physician, the study nurse, and the principal investigator. When it comes to the details of how responsibilities and tasks are distributed and how stakeholders interact with one another, recruitment processes start to show large variability. Clinical trial recruitment support systems (CTRSS) aim to improve the recruitment process in terms of effectiveness and efficiency. To increase the quality of future CTRSS reports, we propose a checklist of items that should be included

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