IDDI Webinar on the SOCRATES (Standard of Care Randomized Trials) MODEL
LEARN ON THE CHALLENGES AND OPPORTUNITIES OF THE STANDARD OF CARE RANDOMIZED TRIALS (SOCRATES) MODEL IN TERMS OF ETHICS, REGULATORY AND STATISTICAL ISSUES
ABSTRACT:
It is often the case in drug development, particularly in oncology, that a randomized trial is launched with considerable uncertainty about the final sample size required to demonstrate a clinically meaningful and statistically significant improvement in results over the control treatment. Group-sequential designs have an established role in randomized trials and allow for safety monitoring as well as early decisions regarding efficacy and futility of the new treatment. In some trials, it may be interesting to foresee the possibility of adapting the final sample size if results at an interim analysis suggest the possibility of a positive trial, albeit with a less pronounced treatment effect than initially anticipated. Such adaptive designs that allow for sample-size reassessment have gained traction in recent years. However, they pose several issues that require consideration and advanced statistical input. 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 reassessment. 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 reassessment 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.
KEY TAKEWAYS:
During this webinar, the participant will:
- Be exposed to some of the challenges in getting reliable evidence for health care options from randomized trials and the greater reliance on observational data for many individualized decisions
- Hear about some practical approaches to more routinely embed randomization into standard of care options including the SOCRATES model.
- Participate in discussions about whether we can make some of these approaches more of a reality.
SPEAKER:
