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THE PHARMA REVIEW (JULY - AUGUST 2013)

Management of Clinical Trials in India Current Perspective and Way Forward

Dr. Amit Dang1 & Dr. Amit Garg2

Introduction: Clinical trials serve as a key research tool for advancing medical knowledge and patient care. They hold their importance in scenarios like new approaches in safety and well-being of the patients and in determining treatments or strategies for certain illnesses or groups of people. Most commonly, clinical trials are done to test the safety and effectiveness of drugs and devices. Usually, they are sponsored by pharmaceutical companies and are conducted by research teams including doctors and other medical professionals. Over the years, many clinical trial co-ordinators have emphasized repeatedly the need for large, randomized, controlled trials1 for generating highest level of evidence for guiding clinical practice. Trial management is essential amongst the key competencies that are needed to deliver high-quality trials. However, there is not much mention in the literature about their management and successful conduct. Also, due to lack of a structured, practical, business like approach to trial management, many clinical trials fail to deliver the right objective. It has been observed that well designed trials are the basis for addressing important clinical questions but the success goes hand in hand with their management. Clinical trials require coordinated processes and systems, regardless of the size, scope, costs or duration. The current review discusses about the new Clinical Trial Management Portal (CTMP) developed for efficient management of clinical trials. 

 

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