Accrual Suspensions in Phase II/III Trials
Author Information
Author(s): Hu Chen, Freidlin Boris, Korn Edward L.
Primary Institution: Johns Hopkins University School of Medicine
Hypothesis
How frequently does accrual suspension occur in phase II/III oncology trials, and can a calendar backstop help reduce delays in the transition from phase II to phase III?
Conclusion
Phase II/III trials with an accrual suspension and a predefined backstop for the phase II analysis can be a useful tool for minimizing patient exposure to ineffective experimental treatments while still obtaining the trial results in a timely fashion.
Supporting Evidence
- Thirteen of the 14 trials had designed accrual suspensions.
- Seven of the eight completed trials had designed accrual suspensions, all of which went on longer than their projected suspension times.
- The study suggests that a calendar backstop may help manage delays in trials.
Takeaway
This study looked at trials where they paused recruiting patients to make sure the treatment was working before continuing. They found that having a plan to restart recruiting can help get results faster and keep patients safe.
Methodology
The study identified all phase II/III trials conducted by NRG Oncology and recorded their design characteristics and results.
Limitations
The study primarily focuses on a specific set of trials, which may limit the generalizability of the findings.
Digital Object Identifier (DOI)
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