Clinical Trial Management is an exceptional discipline in the field of Medical Science. Clinical Trial Application of scientific methods to human health is known as Clinical Trial Management.

The Downside of the process is its effects, at times adverse, on human health and well being. A huge amount of capital is also involved in the trials. Proper management of the system, therefore not only becomes crucial but also a complex issue.

Over the years clinical trial and its management have assumed great significance since the patient based observations have not substantiated the claims of questioning doctors about their effectiveness.

One cannot overlook the problems of the unwillingness of the patients to get involved in clinical trials.

The Survey revealed only 10% of the patients expressing their willingness for becoming the subject of clinical trials.

The collaborative environment allows unique independent counterpoints challenging the existing study based theories and this provides unique scope for the career aspirants for out of the ordinary career building.

Detail of the module

This Module will provide students with a solid understanding of the main issues in the design and interpretation of clinical trials.

The Module will outline the fundamental principles of comparative clinical trials in investigating the effectiveness, efficacy, and safety of treatments; and compare the benefits of clinical trials in comparison to alternative study designs. The main features of clinical trials, including methodological and organizational considerations, and the principles of trial conduct and reporting will be described. Key decisions surrounding design (including sample size), delivery and assessment of clinical trials will be explored.

The key steps in implementing a clinical trial are investigated in this  Unit, including clarifying and operationalizing the primary and secondary objectives of clinical trials, the implications of design choices for implementation of a trial, trial governance, clearances (including research and ethical clearance), and data collection and recruitment methods.  The unit will explore quality assurance and control, and investigate data processing and management issues including post-trial monitoring.

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