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Activity Number: 350 - Statistical Issues In Drug Development - 1
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #330326 Presentation
Title: The Emerging and Merging Fields of Benefit-Risk and Health Technology Assessments
Author(s): Susan Talbot* and Shahrul Mt-Isa and Jixian Wang
Companies: Amgen Ltd and Merck and Celgene
Keywords: benefit-risk; HTA; health technology assessment

Whilst health technology assessments (HTA) are typically associated with economic evaluations, benefit-risk assessments (BRA) are often seen as purely regulatory activities. Despite different objectives, the perspectives and requirements of the two domains are becoming more in sync than a decade ago. This is evidenced by the formations of various initiatives to address novel challenges, raising the bar for those involved in providing justifiable evidence for decision-making on health technologies for the good of public health. With increasing methodological demands and considerations that are no longer unique to HTA or regulatory submissions, more issues have surfaced and more questions have been raised. Despite the numerous efforts, the recommendations remain diverse and the efforts remain distinct. Ensuring consistency and transparency in BRA across HTA and regulatory provides real opportunities for statisticians to #LeadWithStatistics. In this talk, an up-to-date review of the outputs from key initiatives, demonstrate how the two fields are converging with a focus on methodologies, and discuss the leadership role of Statistician in BRA across both HTA and regulatory settings.

Authors who are presenting talks have a * after their name.

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