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Cancer screening trials: nuts and bolts
Philip C Prorok1, Pamela M Marcus
1Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892, USA. pp2g@nih.gov
Seminars in Oncology
|August 17, 2010
Summary
Designing and conducting cancer screening randomized controlled trials (RCTs) requires careful planning. This guide details RCT design, sample size, implementation, analysis, and monitoring for robust cancer screening evaluations.
Area of Science:
- Oncology
- Clinical Trials
- Biostatistics
Background:
- Randomized controlled trials (RCTs) are the gold standard for evaluating cancer screening effectiveness.
- The complexities of designing and conducting cancer screening RCTs are often underestimated by researchers.
Purpose of the Study:
- To provide a comprehensive guide on the practical aspects of designing and conducting cancer screening RCTs.
- To inform researchers about critical considerations for successful trial implementation and analysis.
Main Methods:
- Discussion of RCT design choices, including trial type and follow-up duration.
- Explanation of sample-size calculations and trial implementation strategies (recruitment, randomization, data management).
- Overview of data analysis methods, sequential monitoring, and interim analyses.
Main Results:
- Illustrative examples from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and the National Lung Screening Trial (NLST) are used.
- Key considerations for primary analysis (cause-specific mortality) and secondary endpoints (sensitivity) are presented.
Conclusions:
- Successful cancer screening RCTs necessitate meticulous attention to design, operational, and analytical details.
- Lessons learned from past trials inform recommendations for future cancer screening research.
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