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It has long been noticed that the efficacy observed in small early phase studies is generally better than that observed in later larger studies. Historically, the inflation of the efficacy results from early proof‐of‐concept studies is either ignored, or adjusted empirically using a frequentist or Bayesian approach. In this article, we systematically explained the underlying reason for the inflation...
Biomarkers that can help identify patients who will have an early clinical benefit from a treatment are important not only for patients' survival and quality of life, but also for the cost of health care. Owing to reasons such as biological variation and limited machine precision, biomarkers are sometimes measured with large errors. Adjusting for the measurement error in calculating the proportion...
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