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Screen Failure Rates in Contemporary Randomized Clinical Phase II/III Therapeutic Trials in Genitourinary
Sarah E Wong1, Scott A North2, Christopher J Sweeney3
1Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Background:
Screen failures, defined as individuals who undergo screening but are not enrolled in a clinical trial, incur significant costs without contributing valuable data to the study. Despite these costs, there are few published data about the rate or reasons for screen failures in advanced genitourinary cancer clinical trials.
Materials And Methods:
We reviewed 50 phase II and III trials in advanced genitourinary cancers conducted between 1999 and 2016.
Results:
Of the 50 trials, only 48% (24 of 50) published screen failure rates: 68% (13 of 19) of those in prostate cancer, 33% (6 of 18) in kidney cancer, and 58% (5 of 13) in bladder cancer. Among the phase III trials in prostate cancer, the mean screen failure rate was 26% (range, 12%-45%). The main reason for screen failure was reported as ineligibility. Among the phase III trials in kidney cancer, the mean screen failure rate was 25% (range, 21%-29%), with the most frequent reasons being ineligibility and patient refusal. Among the phase II/III trials in bladder cancer, the mean screen failure rate was 19% (range, 4%-28%), with the main reasons being ineligibility and patient refusal.
Conclusion:
Contemporary trials in genitourinary cancer reported screen failure rates of approximately 20% to 30%. Many trials did not report on the numbers of, and reasons for, screen failures. Greater standardization of definitions, methods, and reporting are needed to better understand and decrease screen failure rates in genitourinary cancer clinical trials.
Insights
Screen failures in genitourinary cancer trials are common, often exceeding 20-30%. Many studies fail to report screen failure rates or reasons, hindering efforts to improve clinical trial efficiency.
Area of Science:
- Oncology
- Clinical Trials
- Genitourinary Cancers
Background:
- Screen failures in clinical trials represent a significant cost without data contribution.
- Limited published data exists on screen failure rates and reasons in advanced genitourinary cancer trials.
Purpose of the Study:
- To analyze the reported screen failure rates and reasons in advanced genitourinary cancer clinical trials.
- To highlight the lack of standardized reporting for screen failures in these trials.
Main Methods:
- A review of 50 phase II and III clinical trials in advanced genitourinary cancers (1999-2016).
- Analysis of published screen failure rates and reported reasons for ineligibility.
Main Results:
- Only 48% of trials reported screen failure rates, with rates around 20-30% in prostate, kidney, and bladder cancer trials.
- Ineligibility was the primary reason for screen failure across most genitourinary cancer types.
- Patient refusal was also a significant factor, particularly in kidney and bladder cancer trials.
Conclusions:
- Genitourinary cancer trials exhibit substantial screen failure rates, often not fully reported.
- There is a critical need for standardized definitions, methods, and reporting of screen failures.
- Improved reporting can help understand and reduce screen failure rates, enhancing clinical trial data quality.
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