Workflow to improve patient recruitment for clinical trials within hospital information systems – a case-study

Martin Dugas,Wolfgang E Berdel,Matthias Lange,Carsten Müller-Tidow

doi:10.1186/1745-6215-9-2

Abstract

BackgroundThe identification of suitable patients is a common problem in clinical trials that is especially evident in tertiary care hospitals.MethodsWe developed and analysed a workflow, which uses routine data captured during patient care in a hospital information system (HIS), to identify potential trial subjects. Study nurses or physicians are notified automatically by email and verify eligibility.ResultsAs a case study we implemented the system for acute myeloid leukemia (AML) trials in Münster. During a test period of 50 days 41 patients were identified by the system. 13 could be included as new trial patients, 7 were already included during earlier visits. According to review of paper records no AML trial patient was missed by the system. In addition, the hospital information system further allowed to preselect patients for specific trials based on their disease status and individual characteristics.ConclusionRoutine HIS data can be used to support patient recruitment for clinical trials by means of an automated notification workflow.

Highlights

The identification of suitable patients is a common problem in clinical trials that is especially evident in tertiary care hospitals
As a case study we implemented the system for acute myeloid leukemia (AML) trials in Münster
During a test period of 50 days 41 patients were identified by the system. 13 could be included as new trial patients, 7 were already included during earlier visits

Summary

Introduction

The identification of suitable patients is a common problem in clinical trials that is especially evident in tertiary care hospitals. Patient recruitment is crucial for the success of any clinical trial. Recruitment is a common and relevant issue in clinical trials. Given the high patient turnover of modern hospitals in conjunction with complex inclusion and exclusion criteria of many simultaneous active trials, patient recruitment can be a challenging task. There are several systems to support identification of a suitable clinical trial for a specific patient [3,4]. These systems are usually not integrated into regular patient care. The treating physicians are often not aware about the possibility of a clinical trial in a (page number not for citation purposes)

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Conclusion