Significance of Randomized Clinical Trials

Authors

  • S. Chaudhry Director Solutions, Thane and Consultant Edenwell Therapeutics , Mumbai & Abhijit Trailokya, Sr General Manager, Medical Services , Indoco Remedies Ltd, Mumbai
  • Manoj Naik
  • Abhijit Trailokya

Keywords:

Randomized Clinical Trial, Intent to treat analysis, Sample size, gold standard, Blind trials.

Abstract

The most exacting and reliable research tool for determining if there is a cause-and-effect relationship between an intervention and a result is the randomized controlled trial. When assessing the efficacy and safety of an intervention, a randomized controlled trial can produce high-quality evidence. Every randomized controlled trial (RCT) ought to have predetermined primary outcomes, be registered with a clinical trials database, and possess the necessary ethical permissions. The quality of RCT design and reporting in neurosurgery is low, though of high value in cardiology, endocrinology, infectious disease  and oncology . The prevalence of trial registration has increased over period of time, all regulators now insist such design for approval of the New Chemical Entity or a Biosimilar.

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Published

2023-12-22

Issue

Vol. 13 No. 3 (2023)

Section

Review Article

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