Emulating the LEADER trial in China: a regulatory science case study on non-interventional research.

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Title: Emulating the LEADER trial in China: a regulatory science case study on non-interventional research.
Authors: Zhao J; Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.; Department of Statistics and Clinical Pharmacology, Center for Drug Evaluation, National Medical Products Administration, Beijing, China., Xin X; Department of Statistics and Clinical Pharmacology, Center for Drug Evaluation, National Medical Products Administration, Beijing, China., Song Y; Department of Clinical Evaluation 1, Center for Drug Evaluation, National Medical Products Administration, Beijing, China., Zhang J; Department of Clinical Evaluation 1, Center for Drug Evaluation, National Medical Products Administration, Beijing, China., Wu Y; Department of Biostatistics, Southern Medical University, Guangzhou, Guangdong, China.; Hainan Lecheng Institute of Real World Study, Qionghai, Hainan, China., Wang J; Department of Statistics and Clinical Pharmacology, Center for Drug Evaluation, National Medical Products Administration, Beijing, China., Cui F; Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.; Peking University Medical and Health Analysis Center, Peking University, Beijing, China.; Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing, China.
Source: Frontiers in endocrinology [Front Endocrinol (Lausanne)] 2026 Mar 12; Vol. 17, pp. 1777954. Date of Electronic Publication: 2026 Mar 12 (Print Publication: 2026).
Publication Type: Journal Article
Journal Info: Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101555782 Publication Model: eCollection Cited Medium: Print ISSN: 1664-2392 (Print) Linking ISSN: 16642392 NLM ISO Abbreviation: Front Endocrinol (Lausanne) Subsets: MEDLINE
Database: MEDLINE Ultimate
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ISSN:1664-2392
DOI:10.3389/fendo.2026.1777954