Decision-Making Sub-team

Advancing quantitative and multidisciplinary approaches to decision-making in drug development and clinical trial design.

Overview

The Decision-Making Sub-team focuses on the frameworks, tools, and methodologies used to make go/no-go and resource allocation decisions across the drug development process, including portfolio-level decision analysis, proof-of-concept optimization, and the integration of innovative trial designs into broader development strategies.

Co-leads: Zoran Antonijevic and George Wu

Focus Areas

  • Decision-theoretic frameworks for trial design and portfolio optimization
  • Go/no-go decision criteria in adaptive and master protocol settings
  • Bayesian decision analysis in drug development
  • Quantitative approaches to benefit-risk assessment
  • Integration of innovative designs into development strategy decisions

Selected Publications

  • Beckman RA, Collyar D, Cooner F, Haggstrom J, Niewczas J, Lu C, Mo M, Spann ME, Wathen K, Ye J. ASA BIOP section newsletter on ASA DahShu IDSWG Multidisciplinary Master Protocol Working Group. ASA Biopharmaceutical Section Newsletter, 30(2): 50–52 (2023).
  • Beckman RA, Natanegara F, Singh P et al. Advancing innovative clinical trials to efficiently deliver medicines to patients. Nature Reviews Drug Discovery, 21: 543–544 (2022).
  • Gould AL, Campbell RK, Loewy JW, Beckman RA et al. A framework for assessing the impact of Accelerated Approval. PLoS One (2022). doi:10.1371/journal.pone.0265712

See the full publications list for additional decision-making-related papers.

Get Involved

Contact the IDSWG Leadership Team to connect with the Decision-Making Sub-team co-leads.

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