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With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the …
Cure Models: Methods, Applications and Implementation is the first book in the last 25 years that provides a comprehensive and systematic introduction to the basics of modern cure …
In longitudinal studies it is often of interest to investigate how a marker that is repeatedly measured in time is associated with a time to an event of interest, e.g., prostate …
Medical Risk Prediction Models: With Ties to Machine Learning is a hands-on book for clinicians, epidemiologists, and professional statisticians who need to make or evaluate a …
Global simultaneous development is becoming more necessary as the cost of developing medical products continues to grow. The strategy of using multiregional clinical trials (MRCTs) …
Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a …
This book covers classic epidemiological designs that use a reference/control group, including case-control, case-cohort, nested case-control and variations of these designs, such …
Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. …
The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis …
Value of Information for Healthcare Decision-Making introduces the concept of Value of Information (VOI) use in health policy decision-making to determine the sensitivity of …