Medical Management Series
The medical monitor’s role in Eligibility Review
The main objective of reviewing the eligibility of patients considered for participation in the study is to ensure that all the criteria defining the study population are met. Patients that do not fulfil any of the protocol-defined eligibility requirements at the time of enrolment should be identified in this review. Based on the nature and the objectives of the study, either prospective or retrospective eligibility review can be opted for, each with its own merits and limitations.
Prospective Eligibility Review
In a prospective eligibility review, sites are permitted to enroll a subject into the study only after approval by the medical monitor and following a review of the eligibility-related information obtained during screening. This prospective review can include all results of screening assessment or it can be limited to what is considered as eligibility critical variables.
To avoid delay in patient enrolment due to this added review requirement between screening and enrolment, a robust communication approach is essential. This can be achieved either via a designated electronic platform or a tailored checklist that includes the eligibility related screening variables. In this situation, sites would be required to complete the needed information that will be then reviewed by the medical monitor who will eventually approve subject enrolment, upon confirmation of eligibility.
The prime advantage of prospective review is that the enrolment of subjects is highly controlled per protocol mandates. On the other hand, the major limitation of prospective review is the potential negative impact on the pace of recruitment due to additional operational procedures. However, the negative impact can be avoided via effective training of the team members and site staff and by implementing a robust approach to communication.
Retrospective Eligibility Review
With retrospective eligibility review, individual patient data are reviewed after the enrolment of subjects. This method is associated with the increased risk for enrolment of subjects who have not completely fulfilled eligibility requirements. Traditionally, retrospective eligibility review is conducted directly in the case report form (CRF) or via patient profiles developed by the study data managers, including all eligibility-relevant information.
In a large study including several hundred patients, performing retrospective eligibility review via the CRF or patient profile would be an extremely time-consuming task. Based on our experience, a more efficient method would be a variable-based review, driven by the project-specific eligibility requirements that would perfectly achieve the review objectives and, at the same time, lead to significant reduction in time spent by the medical monitor on this task.
A designated tool that draws data from all data elements that determine eligibility into the study can be designed by the medical monitor along with the data manager. In this study-specific tool, a variable-based algorithm can be created so that any individual data point that does not comply with protocol-defined criteria is flagged for further, focused review.
The final decision whether to implement a prospective or retrospective eligibility review will be dictated by the phase of the study and the positioning of the investigational drug within the development strategy.
Mohamed El Malt, MD, PhD and Vijayanand Rajendran, MD. (2016) Medical management in clinical trials: A roadmap to operational excellence (Part 3 -Study Conduct Phase). Journal for Clinical Studies 8(5): 14-20.
Medical Management in Clinical Trials:
A Roadmap to Operational Excellence
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