Medical Management Series
The role of the medical monitor in selecting the wider cross-functional team
Medical management needs to form the wider cross-functional team that is required to perform the trial successfully.
Depending on the in-house capabilities available, sourcing external business partners is required in almost every clinical trial. This can vary between full service outsourcing where the various activities are outsourced to a selected contract research organization (CRO), or functional outsourcing where the different functional tasks are outsourced to a variety of selected organizations, including CROs, niche service providers and/or other experts.
Ideally, the activities associated with deciding on the need for outsourcing, identifying and carefully selecting the business partner and establishing the associated legal contracts and agreements, should commence once a final protocol synopsis has been established and take place in parallel with the development of the essential documents required for the Clinical Trial Application (CTA). This allows sufficient time for the study team to implement a thorough selection process while avoiding wasting precious time later and perhaps being forced, due to time pressure, to make a hasty decision with regard to the selection of the business partner. This might bring serious consequences at a later stage with regard to the study budget or conduct.
As a key member of the study team, the medical monitor is engaged, along with other operational and outsourcing colleagues, to bring together a team of selected business partners and vendors based on the conceived study plan. Special consideration of the following points should be given by the medical monitor while selecting vendors:
- The therapeutic area experience of the proposed medical and safety team members of the potential business partner,
- The structure of the medical team, their lines of communication and channels of issue escalation,
- The planned approach for daily medical monitoring and safety reporting,
- The process and channels for interaction with investigators and investigational sites,
- The procedures and proposed scheme for data review including both collective study data and individual patient information,
- The intended plan for managing protocol deviations.
In this series of short articles, we have so far seen the essential need for the medical monitor to ensure the successful and timely delivery of the following:
- A sound study design that reflects the objectives of the study within the broad clinical development program,
- The study documents that meet applicable regulatory requirements and provide clear guidance to both the investigational sites and the global team members during the various steps of the study,
- The formation of the wider cross-functional study team that can include both internal and external stakeholders with the necessary experience and capabilities.
Sound decision-making capabilities, application of medical knowledge, adequate training and experience are all to be expected from a medical monitor in order to accomplish these deliverables in the study development stage.
Mohamed El Malt, MD, PhD and Vijayanand Rajendran, MD. (2016) Medical management in clinical trials: A roadmap to operational excellence. Journal for Clinical Studies 8(2): 28-33
Medical Management in Clinical Trials:
A Roadmap to Operational Excellence
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