Authors
Dr. Shah Navas P, Vice-Chairman, Research Cell, IMA KSB, TC 7/171, Kumaranasan Nagar, Ulloor, Trivandrum-11
Abstract
It is a systematic study for new drugs / devices/ interventions in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of these interventions.
Our country is also now fast emerging as a favoured destination for clinical trials by global pharmaceutical and biotech companies that are looking for partnerships or setting up new operations. Two major reasons for its popularity are: easy access and availability of a large, diverse and therapy-naïve population with vast gene pool and lower cost of technical services resulting into lower per patient trial cost. India also has the advantage of having a large pool of highly trained physicians, nurses, and technical personnel; numerous world-class medical facilities; broadly developed information technology infrastructure; a favourable IPR environment and use of English as the primary business and medical language.
Keywords: Clinical trials, Research question, Study design, Validation, Data collection.