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Benefit-Risk Assessment in Pharmaceutical Research and Development

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Table of Contents

Early Clinical Development: Pharmaceutical Benefit-Risk Assessment in Early Development. Full Clinical Development: Key Questions, Issues, and Challenges in Benefit-Risk Assessment in Full Clinical Development. The Clinical Aspects of Benefit and Risk. Quantifying Patient Preferences to Inform Benefit-Risk Evaluations. Benefit-Risk Modeling of Medicinal Products: Methods and Applications. Benefit-Risk Communication: Learning from Our Past and Creating Our Future. Regulatory Review and Policy: Policy Considerations and Strategic Issues Regarding Benefit-Risk. Systematic Approaches to Benefit-Risk Assessment. Post-Launch Assessment: Considerations and Strategies for Benefit-Risk Assessment in the Real World Setting. Benefit-Risk Assessment and the Payer Perspective. Epilogue. Glossary. Index.

About the Author

Andreas Sashegyi is a senior research advisor in the biometrics organization at Eli Lilly and Company, where he divides his time between therapeutic compound support and work in the Benefit Risk Advisory Group. Dr. Sashegyi’s research focuses on the integrated analysis of benefits and risks in pharmaceutical research and development. He received a PhD in biostatistics from the University of Waterloo.

James Felli is a research fellow in the area of drug disposition at Eli Lilly and Company. Dr. Felli is a fellow and current president of the Society of Decision Professionals and an active member of the Decision Analysis Society of INFORMS and the Decision Analysis Affinity Group. His research focuses on developing new benefit-harm models and visualizations, modeling and analyzing stochastic multicriteria decision problems, enriching communication between analysts and nonanalysts, and developing new methods of multidimensional data visualization. He received a PhD in industrial engineering and management science from Northwestern University.

Rebecca Noel is a senior research scientist at Eli Lilly and Company. Dr. Noel is the chair of the Drug Information Association working group for benefit-risk assessment and serves on the Centre for Innovation in Regulatory Science’s Task Force on Benefit-Risk Assessment and the Innovative Medicines Initiative. Her research focuses on developing and promoting systematic approaches to benefit-risk assessment. She received a DrPH in international health and epidemiology from the University of Alabama at Birmingham.


"I think this text makes a strong case for the increasing importance of formal (and potentially quantitative) B-R assessment … readers new to B-R will get a well-rounded perspective of the key considerations and challenges to performing these assessments from thorough discussion of the overarching principles, different perspectives, and work to date. The authors identify several gaps, such as the emerging need to include patient perspective into the equation, and acknowledge that there are no universally accepted statistical methods at this time. Whether you are completely new to B-R or whether you are trying to implement quantitative methods at the company or project level, this book will be useful for statisticians charged with supporting these assessments now and in the future."
—Pharmaceutical Statistics, 2014

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