Taimei’s IWRS system meets more complex randomization needs

February 5, 2024
News
Reading Time: 3 minutes

News
Reading Time: 3 minutes

Background

More sponsors are adopting seamless clinical research designs to shorten the clinical trial cycle and accelerate the launch of new drugs. In addition, clinical trial drug program designs are becoming increasingly complex. Therefore, higher requirements are placed on the complex randomization capabilities of IWRS systems.

Case 1

Multi-stage, seamless randomization design

A multicenter, randomized, double-blind, placebo-controlled clinical study for efficacy and safety in breast cancer patients adopted a two-stage, seamless design. The design included a Phase II dose confirmation and a Phase III efficacy stage. The Phase III dose was determined after the analysis of the main efficacy indicators of all subjects in Phase II was completed. Then, Phase III subjects were immediately enrolled.

Solution

The clinical trial opted for a multi-cohort randomization design. Phase II and Phase III adopted independent randomization methods. At the beginning of the project, all configurations of Phase II and the basic configuration for Phase III were completed. Only the dose group settings could be changed after Phase II was completed and the Phase III dose was determined. It was put into use quickly and met the requirements for rapid start-up in Phase III.

Case 2

Multiple randomization design plans

In a specific study on blood pressure control in stroke subjects, once the subjects entered the experimental group or the control group according to the stratified randomization method, they were randomly enrolled into two subgroup studies according to their respective inclusion criteria. Both subgroups were used for pilot trials embedded in the main study. The goal was to enroll as many patients as possible while achieving the primary study sample size.

Solution

The final solution was to design a secondary randomization plan for the subgroups. After the subjects were randomized for the first time, the differentiating factors of the primary group were used to randomize subjects in the secondary group.