Background of My Research
Clinical Trial
A clinical trial is an experimental performed on human beings to study and assess the effect of an intervention, and it is performed prospectively. In the clinical development of a new drug, most of the trials are classified into one of the following phases: phase I, phase II, phase III and phase IV. The nomenclature is used to describe the objective and goal of each phase.
Broadly, the purpose of a phase I trial is to study the human pharmacology and safety, phase II is to explore therapeutic activity, phase III is to demonstrate or confirm the therapeutic activity observed in phase II, and finally, phase IV is conducted after drug approval to understand better the usage of the therapeutic agent according to the approved indication.
Phase II Trial
Most of the phase II trial designs are considered in isolation. Additionally, resources such as patients and money are essentially finite. Thus, the decision made at the end of each trial will inevitably influence the planning and development of other trials. It is then necessary to consider each clinical trial as part of a whole series of trials.
Objective
The objective of this project is to optimise the number of patients needed for each individual trial by maximising the power of each trial which is considered as part of a series of trials while maintaining a maximally accepted type I error at level alpha.