Interim analysis: A rational approach of decision making in clinical trial.
Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.
PhD Scholar, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India.
Amal
A
Kumar
Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India.
Bhaswat S
BS
Chakraborty
Clinical trial operation method; decision making; interim analysis; rational approach