All Times EDT
Keywords: Master Protocols, Complex and Innovative Designs, Adaptive Designs, Adaptive Design, Randomization, Treatment Adaptations
Master Protocols are complex innovative clinical trials designed with multiple dimensions such as substudies, subgroup-populations, and sub-protocols. Many Master Protocols are designed as perpetual and require adaptations to be performed across the study’s duration. The type of adaptations that are common in these complex studies are related to the introduction of new treatments, discontinuation of existing treatments, and may also include adjustment to the allocation ratio. These treatment adaptations directly impact the study’s randomization scheme.
To be able to effectively implement these treatment adaptations with minimal disruption, the randomization scheme should be designed with flexibility. Otherwise, a new randomization scheme needs to be generated for each treatment adaptation, which can add significant delay. The optimal level of flexibility would allow treatment adaptations to be applied to the randomization scheme in real time (without having to create a new randomization scheme).
Figuring out the parameters of an adaptable randomization scheme can be challenging since there may be many unknown factors. Going through an effective evaluation for the study-specific requirements is fundamental in the randomization design process. This poster will exhibit the key considerations to include in this evaluation. These considerations consist of defining any required subgroups, number of known / estimate of unknown additional treatments, treatment allocation adjustments, site variability and subject eligibility. Examples in this poster will illustrate methods to design the randomization scheme with flexibility to allow for seamless / real-time adaptations to occur across the study’s duration.