Benefit-risk assessment methods in medical product development (2016) Pdf Free Download

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Evaluation of a new treatment has always required a benefit–risk (B–R) assessment. However, in the past, the assessment tended to be informal and was often subjective, involving judgments from separate assessments of efficacy and safety. Notably, a few regulatory submissions in the last few years failed to gain regulatory approval because of benefits that did not outweigh risks. Such failures speak to the importance of structured B–R assessments to improve consistency, transparency, communication, and objectivity. However, B–R assessment is multifaceted and complex, and the B–R landscape is still evolving. There is increased interest and effort from companies, regulatory agencies, and other governance bodies to further enhance structured B–R assessments. Amid numerous existing frameworks, metrics, estimation techniques, and utility survey techniques in B–R assessment, however, there is still no commonly accepted B–R approach. Guidance on how to select specific B–R frameworks and quantitative methods, along with case studies and best practice sharing, is still lacking.

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