Adaptive Design offers greater flexibility and the possibility to modify a study in progress. Modifications can include: sample size, criteria for inclusion/exclusion, changes in doses or treatment regimen, study endpoints, and the possibility of early closure. At each stage of the study, the probability of success can be quantified and the study team can be full informed in order to evaluate risks and benefits associated with each decision.
Implementing Adaptive Design
Adaptive Design has a critical role in modern protocol planning. Central to this concept is scenario planning through trial simulation which acts as a critical “stress test” for protocol design and a key tool for demonstrating the value of adaptive design.
|Early Stopping||Sample Size re-assessment|
|Change in treatment allocation ratios||Dropping/Adding Treatment arms|
|Alterations of hypotheses (non-inferiority vs superiority)||Select patient populations (inclusion/exclusion criteria)|
|Use of different test statistics||Combination of trial phases (adaptive
CROS NT has a team of statisticians with 20+ years of experience in adaptive trial design who offer consultancy on a case-by-case basis
CROS NT can assist with the following regarding Adaptive Design:
- Work with Sponsors to improve the trial design
- Use simulations to calculate the power of the sample size and probability of success
- Define the decision rule for interim analyses and provide statistical justification
- Provide Electronic Data Capture and reporting to efficiently manage data for interim analyses