Clinical Study Randomization

What is Randomization?

Randomization involves randomly allocating treatment assignments across pre-designated groups. 

Randomization has been used for more than 50 years and is the preferred method of  patient assignment in clinical trials. It eliminates the source of bias in treatment assignment and facilitates blinding the treatment assignment to the investigator, participants and evaluator. 

How Cenduit Randomization Excels?

The Cenduit Interactive Response Technology (CIRT) platform supports all aspects of patient management from screening through to treatment completion, with even the most complex randomization schemes; from static, stratified, or cohort controlled dose escalation with unknown endpoints, to covariate adaptive minimization, and adaptive trial designs.

Cenduit has experience in all of the following randomization schemes and techniques including:

• STATIC RANDOMIZATION – This design includes Stratification, Dynamic by Site and/or Country Randomization, Cohorts, Capping, Dependency on Criteria entered during screening/randomization, and block sizes.
  
  
• COVARIATE ADAPTIVE – This design involves allocation to minimize some measure of variance or efficiency, balancing patients between treatment arms when there are too many stratification factors to use standard methods.  This includes collaboration between the Programmer, Statistician, and Validation Specialist to develop statistical algorithms for randomization schema and subsequent validation testing strategies
  
  
• RESPONSIVE ADAPTIVE – This design evolves depending on the responses of those enrolled, utilizing “Play the Winner” mentality.  It functions by removing inferior treatment arms mid trial if needed.

Are you ready to learn more? Do you have a question on how we can help you with Clinical Study Randomization? Please contact our team via the form below.