Designing a randomized trial with sample-size re-estimation: Challenges and Best Practices
LEARN ON SAMPLE-SIZE RE-ESTIMATION, CONDITIONAL POWER AND THE PROMISING-ZONE METHOD.
During this webinar, the participant will:
- Be exposed to the concepts of sample-size re-estimation, conditional power, and the promising-zone method
- Gain insights into the planning of sample-size re-estimation and the operationalization of such designs
- Understand the benefits and limitations of sample size re-estimation in relation to the clinical setting in which the study is conducted
In this webinar, we will play the part of a sponsor consulting a statistician with the goal of designing a randomized trial with sample-size re-estimation. We will discuss the concept of conditional power and the promising-zone method, and we will present a pragmatic view of some issues, including when to plan the sample-size re-estimation in the course of the accrual, how to select the amount of sample-size increase, and how to operate such trials in practice. We will also discuss the pros- and cons- of using this type of design in relation to the clinical setting in which the trial is designed and endpoints it uses. Moreover, we will discuss the regulators’ views and illustrate our discussion with practical examples.