Author

S. Mt-Isa

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Review Open access Sep 2026

Benefit-Risk Balance for Medicinal Products: Report Summary from the Council for International Organizations of Medical Sciences (CIOMS) Working Group XII.

PURPOSE Benefit-risk assessment (BRA) is a foundation of regulatory decision making and clinical practice for medicinal products. Although historically assessments relied on expert judgment and narrative summaries, over time, expectations have shifted toward approaches that are more structured, transparent, and patient...

S. Hill, Claudia Ana Ianos, L. Plouffe et al. · Clinical Therapeutics · 0 citations

Review Open access Aug 2026

Assessing real-world evidence utilization in oncology health technology assessments: insights from external control-arm studies

Data source selection, patient population comparison, and transparent presentation of potential biases were important factors in enhancing the credibility and utility of RWD-based ECAs in HTA decision-making processes.

Gleicy Macedo Hair, M. Hanisch, S. Mt-Isa et al. · Oncology Reviews · 0 citations