INVESTED-Medicare链接研究：通过临床试验与真实世界数据融合提升证据生成能力
Enhancing Evidence Generation by Linking Randomized Clinical Trials to Real‐World Data: The INVESTED‐Medicare Linkage Study
作者：Hanseul Cho、HoJin Shin、Mehdi Najafzadeh、Brian Claggett、Janinne Ortega‐Montiel、Jun Liu、Julie M. Paik、Narlina F. Lalani、Marie C. Bradley、John Concato、Scott D. Solomon、Orly Vardeny、Elisabetta Patorno
单位：Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.；Division of General Internal Medicine & Health Services Research, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.；Johnson & Johnson Innovative Medicine, Titusville, New Jersey, USA.；UCB, Cambridge, Massachusetts, USA.；Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.；Division of Nephrology, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.；VA Health Care System, Minneapolis, Minnesota, USA.；Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
摘要
2026年9月7日，《Clinical Pharmacology & Therapeutics》在线发表INVESTED-Medicare链接研究论文。该研究探索将随机对照临床试验数据与美国Medicare真实世界健康数据相链接的方法学框架，旨在增强临床试验结果的外部有效性与证据生成效率，为监管机构基于真实世界证据支持审评提供技术路径参考。
AI 主编 · 推荐理由推荐理由
本文提供的RCT与RWD链接方法学对药企临床试验设计与真实世界证据桥接具有参考价值。企业在注册申报中可借鉴该框架，利用已有真实世界数据增强临床试验的泛化性论证，提升证据质量。