The primary objectives of the series are to provide useful reference books for researchers and scientists in academia, industry, and government, and also to offer textbooks for undergraduate and graduate courses in the areas of biostatistics and bioinformatics. The book series will provide comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics and bioinformatics, such as those in biological and biomedical research.
The scope of the series is wide, including applications of statistical methodology in biology, epidemiology, genetics, pharmaceutical science and clinical trials, public health, and medicine. The series is committed to providing easy to understand, state-of-the-art references and textbooks. In each volume, statistical concepts and methodologies will be illustrated through real world examples whenever possible.
Please contact us if you have an idea for a book for the series.
Bayesian Precision Medicine
Statistical Methods for Dynamic Disease Screening and Spatio-Temporal Disease Surveillance
Development of Gene Therapies Strategic, Scientific, Regulatory, and Access Considerations
Quantitative Drug Safety and Benefit Risk Evaluation Practical and Cross-Disciplinary Approaches
By Peter F. Thall
May 14, 2024
Bayesian Precision Medicine presents modern Bayesian statistical models and methods for identifying treatments tailored to individual patients using their prognostic variables and predictive biomarkers. The process of evaluating and comparing treatments is explained and illustrated by practical ...
By Peihua Qiu
May 13, 2024
Disease screening and disease surveillance (DSDS) constitute two critical areas in public health, each presenting distinctive challenges primarily due to their sequential decision-making nature and complex data structures. Statistical Methods for Dynamic Disease Screening in Spatio-Temporal Disease...
By Avery McIntosh, Oleksandr Sverdlov
March 13, 2024
Cell and gene therapies have become the third major drug modality in pharmaceutical medicine of the 21st century after low molecular weight and antibody drugs. The gene therapy (GTx) field is rapidly advancing, and yet there are still fundamental scientific questions that remain to be answered. ...
By Anna Heath, Natalia Kunst, Christopher Jackson
February 22, 2024
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 decisions to assumptions, and to prioritise and design future research. These methods, and their use in cost-effectiveness ...
By Dongfeng Wu
February 06, 2024
Cancer screening has been carried out for six decades, however, there are many unsolved problems: how to estimate key parameters involved in screenings, such as sensitivity, time duration in the preclinical state (i.e., sojourn time), and time duration in the disease-free state, how to estimate the...
By Vivek Pradhan, Ashis Gangopadhyay, Sandeep M. Menon, Cynthia Basu, Tathagata Banerjee
January 29, 2024
Confidence Intervals for Discrete Data in Clinical Research is designed as a toolbox for biomedical researchers. Analysis of discrete data is one of the most used yet vexing areas in clinical research. The array of methodologies available in the literature to address the inferential questions for ...
By William Wang, Melvin Munsaka, James Buchanan, Judy Li
January 29, 2024
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual ...
By Gang Li, Bruce Binkowitz, William Wang, Hui Quan, Josh Chen
January 29, 2024
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) has become the preferred method for developing new medicines. Implementing the same protocol to include subjects from ...
By Kristine Broglio, Binbing Yu
November 27, 2023
Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases....
By Sang Joon Lee, Shein-Chung Chow
September 25, 2023
Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval...
By Jianrong Wu
July 24, 2023
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. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, ...
By J. Sunil Rao
July 11, 2023
A health disparity refers to a higher burden of illness, injury, disability, or mortality experienced by one group relative to others attributable to multiple factors including socioeconomic status, environmental factors, insufficient access to health care, individual risk factors, and behaviors ...