A comparison of a new multinomial stopping rule with stopping rules of fleming and gehan in single arm phase II cancer clinical trials
2011
New Stopping Rule for Cancer Trials
publication
Evidence: moderate
Author Information
Author(s): Goffin John R, Pond Greg R, Tu Dongsheng
Primary Institution: McMaster University
Hypothesis
Can the Dual Endpoint Stopping Rule (DESR) improve sensitivity in phase II cancer trials compared to traditional methods?
Conclusion
The DESR may enhance trial sensitivity to active drugs while allowing for early stopping when drug activity is unlikely.
Supporting Evidence
- The DESR was more likely to allow continuation to the second stage of accrual compared to Fleming rules.
- The DESR rejected the null hypothesis more frequently when EPD rates were low.
- The study found that the choice of EPD parameters significantly impacted trial outcomes.
Takeaway
This study looks at a new way to decide when to stop cancer trials early, which could help find effective drugs faster.
Methodology
The study compared the DESR with Fleming and Gehan stopping rules using data from phase II trials.
Limitations
The study used arbitrary EPD rates and lacked follow-up phase III studies to confirm findings.
Digital Object Identifier (DOI)
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