Learn More About Clinical Research
Irrespective of the fact that a drug has been developed in India or abroad, or whether its clinical studies have already been conducted abroad, every new drug needs evidence from clinical research to support its launch. Similarly, the launch of new formulations, drug delivery systems or even new fixed-dose combinations, require clinical data before it can be marketed. It is obvious that the area of clinical research holds immense scope and promise as, without the supporting data, drug launches are not feasible. Hence, rather than viewing clinical research as a subsidiary to pre-clinical research, it is important to understand that clinical research has to be conducted even in cases where preclinical studies are not warranted.
Clinical research is a growing career area. In fact, clinical research is one of the best areas to work on right now and for the future for this industry is going to grow substantially in the future.
DETAIL OF THE MODULE
This module will provide aspirants 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 module, 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 module will explore quality assurance and
- Control, and investigate data processing and management issues, including post-trial monitoring
