First-of-its-kind Textbook Explores Benefit-Risk Assessments in Pharmaceuticals

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A new book, with chapters authored by three researchers at RTI Health Solutions, a business unit of RTI International, provides a first-of-its-kind overview of benefit-risk assessment from both the scientific and business viewpoint. The book, titled "Benefit-Risk Assessment in Pharmaceutical Research and Development," aims to explore the current status and future directions of the field.

Bringing together the expertise of 15 contributors from academia and the pharmaceutical industry, the book offers an easy-to-read guide on various facets of benefit-risk assessment in the major stages of pharmaceutical research and development. Contributing RTI authors include Elizabeth Andrews, Ph.D., Alicia Gilsenan, Ph.D., and Brett Hauber, Ph.D.

Seeking to bridge the knowledge gap between the quickly evolving area of benefit-risk assessment and pharmaceutical practitioners, the book follows the chronological order of drug development, enabling readers to quickly focus on a particular stage of development.

"Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment," said Gilsenan, senior director of epidemiology at RTI Health Solutions. "We tried to alleviate this gap by providing a sufficient overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical research and development spectrum."

The book also offers insight into the role of benefit-risk assessment by highlighting perspectives of different stakeholders, including patients, developers, regulators, and payers.

"This book is unique because it's relevant for those in both technical and managerial roles," said Hauber, senior economist and vice president of health preference assessment at RTI Health Solutions. "Our hope is that it will enable readers to communicate more effectively across their development chain, as well as rationally and thoughtfully embed benefit-risk assessment into their research and development."

Hauber co-authored a chapter on quantifying patient preferences to inform benefit-risk evaluations. Gilsenan and Andrews co-wrote a chapter on strategies for benefit-risk assessment in the real-world setting.

"We avoided advocating for or against specific methodologies for benefit-risk assessment and instead highlighted the inherent complexities in assessing clinical effectiveness and safety using real-world evidence and the importance of using a rigorous and systematic approach to evaluate that evidence," said Andrews, vice president of pharmacoepidemiology and risk management at RTI Health Solutions.

The book, published by CRC Press, is available on leading commercial bookseller websites. The book was edited by Andreas Sashegyi, James Felli, and Rebecca Noel, all with Eli Lilly and Company.

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