By Stephen L. George, Xiaofei Wang, Herbert Pang
Cancer medical Trials: present and arguable matters in layout and Analysis offers statisticians with an figuring out of the serious demanding situations at present encountered in oncology trials. famous statisticians from educational associations, regulatory and govt firms (such because the U.S. FDA and nationwide melanoma Institute), and the pharmaceutical proportion their broad stories in melanoma medical trials and current examples taken from real trials.
The publication covers issues which are usually difficult and infrequently arguable in melanoma scientific trials. many of the concerns addressed also are vital for scientific trials in different settings. After discussing basic issues, the ebook makes a speciality of elements of early and past due section scientific trials. It additionally explores custom-made medication, together with biomarker-based medical trials, adaptive medical trial designs, and dynamic remedy regimes.
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Additional info for Cancer clinical trials: current and controversial issues in design and analysis
These conventional measures assume the estimated treatment effects on S and T are fixed and ignore the correlation between endpoints within a same patient and therefore are considered less statistically sophisticated. However, both the conventional and the model-based trial-level surrogacy measures quantify the ability to predict the treatment effect on a true endpoint based on observed treatment effect on the surrogate endpoint. , [87, 91]). This research led to the acceptance of disease-free survival (DFS) as a surrogate endpoint for overall survival (OS) in adjuvant colon cancer studies by FDA.
This book provides readers with a current understanding of the critical issues in these and other topics with state-of-the-art approaches. Each chapter is written by well-known statisticians from academic institutions, regulatory agencies (FDA), the National Cancer Institute, or the pharmaceutical industry, all with extensive experience in cancer clinical trials. Examples are taken from actual cancer clinical trials. The topics covered are: Endpoints for cancer clinical trials (Chapter 1) Use of historical data (Chapter 2) Multiplicity (Chapter 3) Analysis of safety data (Chapter 4) Development and validation of predictive signatures (Chapter 5) Phase I trials and dose-finding (Chapter 6) Design and analysis of phase II cancer clinical trials (Chapter 7) Sample size for survival trials in cancer (Chapter 8) Non-inferiority trials (Chapter 9) Quality of life (Chapter 10) Biomarker-based clinical trials (Chapter 11) Adaptive clinical trial designs in oncology (Chapter 12) Dynamic treatment regimes (Chapter 13) Our focus is on cancer clinical trials and the topics covered are important in cancer trials.
Response rate is rarely chosen as the primary endpoint in phase III trials. The current stance of FDA is that cancer drug approval should be based on more direct evidence of clinical benefit, such as improvements in overall survival (OS), health-related quality of life, tumor-related symptoms, and/or physical functioning . However, exceptions do exist. For example, response rate has been used as the primary endpoint for FDA accelerated approval trials, where limited accrual is anticipated for rare diseases.
Cancer clinical trials: current and controversial issues in design and analysis by Stephen L. George, Xiaofei Wang, Herbert Pang