SUPPORTING EXECUTION OF A CLINICAL TRIAL

摘要

The execution of a clinical trial is supported in the following manner. Patient model data is provided for modeling a patient-level workflow in the clinical trial in accordance with a trial protocol. Clinical data of patients participating in the clinical trial is accessed. Using a workflow engine, an instance of the patient-level workflow is instantiated for each of the patients to obtain a plurality of patient-level workflow instantiations. Each of the patient-level workflow instantiations is executed independently based on the clinical data of each respective one of the patients. The patient model data may comprise or be linked to a rule associated with a step of the patient-level workflow. The rule may be executed when the workflow engine reaches the step in one of the patient-level workflow instantiations. Accordingly, a virtual representation of the clinical trial on a patient-level is obtained which represents the actual state of the clinical trial yet which is computer-accessible. Having such a virtual representation of the clinical trial allows the clinical trial to be easily monitored, actively managed, etc., thereby facilitating its execution.

主权项

1. A system for supporting execution of a clinical trial, the clinical trial being defined by a trial protocol, the system comprising:
a model repository comprising patient model data for modeling a patient-level workflow in the clinical trial in accordance with the trial protocol, the patient model data modelling the patient-level workflow as a plurality of steps; a clinical data interface for accessing clinical data of patients participating in the clinical trial; a workflow engine configured for:
i) Instantiating an instance of the patient-level workflow for each of the patients to obtain a plurality of patient-level workflow instantiations, andii) executing each of the patient-level workflow instantiations independently by progressing through the plurality of steps of each of the patient-level workflow instantiations based on the clinical data of each respective one of the patients; wherein the patient model data comprises or is linked to a rule, the rule being associated with a step of the patient-level workflow; wherein the system further comprises:
a rule engine for evaluating the rule when the workflow engine reaches the step in one of the patient-level workflow instantiations to enable the workflow engine to progress through the step based on an outcome of said evaluating.