Medical Management Series
Medical Management in the 4 phases of a clinical trial
The clinical research physician is a key member of any drug development team and forms the backbone for all medical and scientific aspects of the clinical research programs. In the context of a clinical trial, a research physician with the required therapeutic area expertise and the practical knowhow of clinical trial conduct is usually referred to as the medical monitor.
The complex responsibilities of the medical monitor in a clinical trial are not only confined to the period of study conduct (first-patient-in to last-patient-out), but he or she is expected to be a key member of the study team from the first steps of study design, throughout the trial period and until the final Clinical Study Report is approved.
With the incremental demand for proactive safety surveillance during the conduct of clinical trials, and throughout the drug marketing period, the role of medical management is at the fore in ensuring the safety and wellbeing of trial participants and, at the same time, the scientific robustness of the data obtained.
Each clinical trial can be separated into four major phases and medical management plays a key part in each. These phases are:
We shall consider each of these phases separately in this article series, through which we will share a roadmap for operational excellence covering the key contributions that medical monitors can make during the different phases of the clinical trial.
Introduction to the Development Phase
The development phase is a critical part of clinical studies and requires a collaborative effort from the medical, clinical operations, data management, regulatory affairs, and statistics departments. The framework of medical management to be followed throughout the course of the trial is founded during this phase of the clinical study.
The development phase starts with the establishment of a study concept. This concept is based on a clear understanding of the specific clinical development strategy for the investigational drug and the positioning of the intended study within the development program. This study concept must serve the company strategy and development objectives.
At the end of the development phase, the study team should have taken all relevant decisions, developed all required documents and accumulated all essential information that permit kicking off the various activities that set the scene for patient recruitment.
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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