Drug Development and Sports: The 10-Run Rule and Futility
In this episode of "In the Interim…", Dr. Scott Berry and Dr. Nick Berry investigate how futility in clinical trials and stopping rules in sports illuminate very similar decision problems, albeit with very different consequences. Drawing from baseball’s 10-run rule, tournament cuts in golf, the discussion confronts traditional and Bayesian strategies for interim decisions. The episode explains why simulation, not historical trial review, provides the empirical backbone for futility boundaries in clinical trials, and details the mechanics and consequences of aggressive stopping criteria. Using the Biogen aducanumab Alzheimer’s trials, the conversation exposes how a futility rule based on 20% predictive probability halted trials even when meaningful probability of success remained. Scott and Nick address the influence of ethical considerations, cost, regulatory priorities, and statistical rigor, and contrast Bayesian predictive probability’s strengths over conditional power.
Key Highlights
- Dissects sports futility rules (10-run rule, golf cuts, Bill James heuristic) and their application to clinical trial design
- Argues for prospective simulation to define adaptive futility thresholds
- Explains how Bayesian predictive probability provides a more robust framework than conditional probability for interim adaptive decisions
- Details how aggressive futility criteria may prematurely stop trials and risk missing beneficial treatments, as in the aducanumab case
- Explores the intersection of ethics, patient safety, operational efficiency, regulatory standards, and trial cost
More description
In this episode of "In the Interim…", Dr. Scott Berry and Dr. Nick Berry investigate how futility in clinical trials and stopping rules in sports illuminate very similar decision problems, albeit with very different consequences. Drawing from baseball’s 10-run rule, tournament cuts in golf, the discussion confronts traditional and Bayesian strategies for interim decisions. The episode explains why simulation, not historical trial review, provides the empirical backbone for futility boundaries in clinical trials, and details the mechanics and consequences of aggressive stopping criteria. Using the Biogen aducanumab Alzheimer’s trials, the conversation exposes how a futility rule based on 20% predictive probability halted trials even when meaningful probability of success remained. Scott and Nick address the influence of ethical considerations, cost, regulatory priorities, and statistical rigor, and contrast Bayesian predictive probability’s strengths over conditional power.
Key Highlights
- Dissects sports futility rules (10-run rule, golf cuts, Bill James heuristic) and their application to clinical trial design
- Argues for prospective simulation to define adaptive futility thresholds
- Explains how Bayesian predictive probability provides a more robust framework than conditional probability for interim adaptive decisions
- Details how aggressive futility criteria may prematurely stop trials and risk missing beneficial treatments, as in the aducanumab case
- Explores the intersection of ethics, patient safety, operational efficiency, regulatory standards, and trial cost
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