Dr Evan Papanastasiou | MD MSc PhD MBA
The lead physician, as a valuable medical member of the clinical team, provides both medical cover and leadership in clinical trials; possesses extended knowledge and clinical experience in the targeted disease area and facilitates the translation of scientific finding to clinically meaningful outcomes.
“An expert is one who has made all the mistakes which can be made in a narrow field.”
Niels Bohr, Danish Physicist
The lead physician provides critical input in many aspects of planning, initiating and monitoring of a clinical trial, as well as in supervising data processing and interpretation of data.
As a medical expert, the lead physician is the primary responsible for establishing and approving scientific methods underlying the design and implementation of CSPs as well as guaranteeing study compliance with regulatory authorities by understanding and applying all relevant SOPs and ICH GCPs.
The lead physician spends considerable time in starting off, reviewing and approving the multiple clinical documents necessary for the initiation of a clinical trial, such as CSPs, protocol amendments, IBs, informed consent forms and other, in accordance with the requirements of the ethics committee(s) (IEC or IRB).
It is imperative that the lead physician should oversee ongoing data processing, contribute to the refinement of the dataset before the database is ‘locked’; and provide valuable input in summarising and documenting clinical data for regulatory documents (i.e. CSRs), manuscripts as well as other publications as required.
“A leader is one who knows the way, goes the way and shows the way.”
John C. Maxwell, American Author
Leading a clinical study team requires extended collaboration with stakeholders outside sponsor’s matrix, usually positioned within CROs, SMOs or academic centers. The lead physician has a key responsibility to identify, meet, interview and persuade external clinicians to conduct clinical trials; also to lead round-table discussions and maintain regular contact with clinical investigators and medical monitors to solve the multitude of issues or problems arising during the conduct of these multifaceted clinical trials.
As a leader of the clinical study team, the study physician interacts regularly with other professionals within sponsor’s matrix, including physicians, statisticians, pre-clinical scientists, data scientists and project managers. The lead physician normally represents the clinical study team in internal and external meetings, including presentations in conferences, investigators meetings and business boarding meetings.
