Interim analysis: A rational approach of decision making in clinical trial

Amal Kumar, Bhaswat S Chakraborty, Amal Kumar, Bhaswat S Chakraborty

Abstract

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.

Keywords: Clinical trial operation method; decision making; interim analysis; rational approach.

Figures

Figure 1
Figure 1
Plots above show simulated data where p1 = 0.40 and p2 = 0.50
Figure 2
Figure 2
If we look after every ten patients, we get the scenario where we would not stop until all the 200 patients were observed and would conclude that there no significant difference (P = 0.40)
Figure 3
Figure 3
If we look after every forty patients, we get the scenario where we would not stop either. If we wait until the end of the trial (n = 200), we estimate p1 to be 0.45 and p2 to be 0.52. The P value used for testing shows a significant difference of 0.40

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