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Training in Clinical Research in India: Potential and Challenges

Indian Journal of Community Medicine
Medknow Publications
Publication Date
DOI: 10.4103/0970-0218.55267
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  • Agricultural Science
  • Biology
  • Medicine
  • Pharmacology
  • Social Sciences


Clinical Research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis, or for relief of symptoms in a disease.(1) The rapid momentum in the growth of clinical research over the last decade is expected to continue in the near future. This rapid growth is also an attractive business opportunity, with an estimated business worth over US $ 1.5 – 2 billion,(2) with the country receiving increasing attention for the conduction of clinical research.(3) Clinical research is a vital and essential piece in this market jigsaw before the introduction of a new drug or vaccine. Clinical research is not a modern occurrence with the earliest evidences of clinical trials in the writings of Avicenna.(4) He elucidated the rules and principles for testing the effectiveness of new drugs and medications, which forms the basis of clinical pharmacology and clinical trials. One of the well known clinical trials recorded in history was conducted by James Lind aboard the HMS Salisbury.(5) Lind attempted to scientifically evaluate various treatment regimes for the control of scurvy, a major problem affecting sailors during that period. Several other comparative studies were done in the eighteenth and nineteenth centuries. It was in 1926 that Fischer introduced the concept of randomization in agricultural studies.(6) The first human clinical study with randomization was done by Amberson in 1931.(7) He carefully matched 24 patients of pulmonary TB with comparable groups of 12 each with the flip of a coin. This was the first example of the use of randomization for assignment of study participants into groups. The MRC trial for streptomycin was the first trial to use random numbers for allocation to study and control groups.(8) With the emergence of clinical trials as the preferred method for the evaluation of clinical interventions in the last 30 years, the techniqu

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