Clinical Trials

India: A Future Clinical Hub
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India: A Future Clinical Trial Hub
Analysis of Indian and Global conditions, susceptible for emerging India as a Clinical Trial Hub
Kaustubh Aparajit, Samveg Sethi, Nitesh Kumar and Sachin Chavare,
Shailesh J Mehta School of Management, IIT Bombay
1. Concept Definition
1.1 Clinical Trails
Clinical Trials are studies performed with human subjects in order to test the performance of a new drug, new approaches to surgery or procedures to improve the diagnosis of disease and quality of life of the patient.
The National Institute of Health (NIH) in USA defines a Clinical Trial as a prospective biomedical or behavioural research study of human subjects that is designed to answer specific questions about biomedical or behavioural interventions. Clinical Trials consist of a researcher or researchers, also known as investigators who directly observe a study subject or subjects, and/or who collect data to answer a scientific or medical question about the safety or potential benefit of an intervention such as a medication, device, teaching concept, training method, or behavioural change.
Clinical Trials are conducted in following cases:
1. New drug
2. New uses of existing drugs
3. Medical devices
4. New drug delivery system
5. Toxicity studies
1.2 Phases of Clinical Trial
A Clinical Trial is conducted in four different phases which are described in the table below: Phase Objective No. of Subjects Duration Phase I To determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way 50-100 Few weeks Phase II To test the longer term safety and efficacy of the drug 100-300 9 months-2 yrs Phase III Thorough inspection of effectiveness, benefits, range of adverse effects 1000-5000 1-2 yrs Phase IV Post Marketing: Long term information gathering >1000 >2 yrs
Table 1.1: Phases of a Clinical Trial
India: A Future Clinical Hub
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2. Trend of Clinical Trial Business and Global Hubs
In 2012 North...