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Significance of Randomized Clinical Trials

S. Chaudhry, Manoj Naik, Abhijit Trailokya

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.

Keywords


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

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References


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