Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments
- 7h 11m
- Dr. Qi Jiang, Dr. Weili He
- CRC Press
- 2016
Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission.
The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies.
With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.
In this Book
-
The Need for and Future Directions of Benefit–Risk Evaluations
-
Regulatory and Legislative Policy and Science Considerations in the Era of Patient-Centeredness, Big Data, and Value
-
Benefit–Risk Determinations at the FDA Center for Devices and Radiological Health
-
Understanding and Evaluating Uncertainties in the Assessment of Benefit–Risk in Pharmaceutical Drug Development
-
Quantifying Patient Preferences for Regulatory Benefit–Risk Assessments
-
Choice of Metrics and Other Considerations for Benefit–Risk Analysis in Subgroups
-
Sources of Data to Enable Benefit–Risk Assessment
-
Overview of Benefit–Risk Evaluation Methods: A Spectrum from Qualitative to Quantitative
-
Benefit–Risk Evaluation Using a Framework of Joint Modeling and Joint Evaluations of Multiple Efficacy and Safety Endpoints
-
Visualization of Benefit–Risk Assessment in Medical Products with Real Examples
-
Practical Considerations for Benefit–Risk Assessment and Implementation: Vorapaxar TRA-2°P TIMI 50 Case Study
-
A Quantitative Benefit and Risk Assessment to Determine Optimal Retrieval Time for Inferior Vena Cava Filters in Patients without Pulmonary Embolism
-
Benefit–Risk Assessment via Case Studies
