Bishal Gyawali
比沙尔·贾瓦利
MD, PhD
Associate Professor, Department of Oncology and Department of Public Health Sciences; Research Director, Program in Evidence-Based Care肿瘤学与公共卫生科学副教授；循证护理项目研究主任
👥Biography 个人简介
The most influential voice of a generation on cancer drug evidence standards and approval rigor. His systematic analyses revealed that the majority of FDA-approved oncology drugs lack overall survival evidence and exposed surrogate endpoint failures in global oncology, prompting regulatory reflection at the FDA, EMA, and Health Canada while amplifying voices from Nepal and the Global South in shaping evidence standards.
🧪Research Fields 研究领域
🎓Key Contributions 主要贡献
Cancer Drug Approval Evidence Analysis
Demonstrated through landmark systematic reviews that over 70% of FDA cancer drug approvals between 2008 and 2022 were based on surrogate endpoints never validated to predict overall survival benefit, generating regulatory debate and inspiring new FDA guidance on endpoint standards.
Global South Perspective on Oncology Evidence
Championed the principle that cancer drug evidence must be evaluated for applicability in LMIC settings, showing that most drugs approved using surrogate endpoints in high-income countries offer limited value when cost, access, and quality of life are incorporated in LMIC contexts.
Representative Works 代表性著作
Oncology Drug Approvals: Does Approval Indicate Value?
JAMA Internal Medicine (2019)
Widely cited analysis showing the proportion of FDA oncology approvals lacking overall survival evidence and questioning the translation of surrogate endpoint gains into meaningful patient benefit.
🏆Awards & Recognition 奖项与荣誉
📄Data Sources 数据来源
Last updated: 2026-01-15 | All information from publicly available academic sources
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