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Regulators have encouraged the use of external data and real\u2010world evidence (RWE) to improve efficiency, yet adoption in confirmatory settings remains limited by concerns over heterogeneity and bias. We conducted a proof\u2010of\u2010concept study to assess the feasibility and regulatory value of a hybrid Bayesian borrowing design to support a Phase III RCT of Dexamethasone Intracameral Drug\u2010Delivery Suspension (DEXYCU) in China. Using the Equivalence Probability Propensity Score Meta\u2010Analytic\u2010Predictive (EQPSMAP) approach, we integrated three data sources\u2014a global RCT, a regional Phase III RCT in China, and a real\u2010world data (RWD) in China. The method\u2019s performance was evaluated via point estimates and 95% credible intervals for the primary efficacy endpoint. The hybrid design based on EQPSMAP demonstrated greater robustness and accuracy in the presence of baseline imbalances and heterogeneous data. Compared to a traditional RCT, the hybrid design reduced the required sample size by 41 to 158 patients and shortened trial duration by approximately 2 to 5\u2009months while preserving internal validity. This study demonstrated the feasibility and regulatory value of hybrid Bayesian designs in late\u2010phase trials. The approach offers a practical, bias\u2010controlled framework for integrating external data into regional drug development and regulatory decision making.<\/jats:p>","DOI":"10.1002\/cpt.70010","type":"journal-article","created":{"date-parts":[[2025,8,1]],"date-time":"2025-08-01T04:55:10Z","timestamp":1754024110000},"page":"1523-1531","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Hybrid Design Incorporating External Data to Evaluate Dexamethasone Intracameral Drug Delivery Suspension for Post\u2010Cataract Surgery Inflammation"],"prefix":"10.1002","volume":"118","author":[{"given":"Yuanyuan","family":"Zhao","sequence":"first","affiliation":[{"name":"Hainan University  Haikou Hainan China"},{"name":"Hainan Lecheng Institute of Real World Study  Qionghai Hainan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-1756-2030","authenticated-orcid":false,"given":"Keer","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Southern Medical University  Guangzhou Guangdong China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Zhou","sequence":"additional","affiliation":[{"name":"Center for Drug Evaluation National Medical Products Administration  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Zhao","sequence":"additional","affiliation":[{"name":"Health Science Center Peking Universtiy  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dingheng","family":"Zhang","sequence":"additional","affiliation":[{"name":"China Center for Food and Drug International Exchange  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junyue","family":"Wan","sequence":"additional","affiliation":[{"name":"Hainan Center for Drug and Medical Device Evaluation and Service  Haikou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weihong","family":"Yuan","sequence":"additional","affiliation":[{"name":"Hainan Lecheng Institute of Real World Study  Qionghai Hainan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xi","family":"Chen","sequence":"additional","affiliation":[{"name":"Hainan Lecheng Institute of Real World Study  Qionghai Hainan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ming","family":"Tan","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Bioinformatics and Biomathematics Georgetown University  Washington District of Columbia (DC) USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fuqiang","family":"Cui","sequence":"additional","affiliation":[{"name":"Health Science Center Peking Universtiy  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shein\u2010Chung","family":"Chow","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Bioinformatics Duke University School of Medicine  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4939-4552","authenticated-orcid":false,"given":"Ying","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Southern Medical University  Guangzhou Guangdong China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,7,31]]},"reference":[{"key":"e_1_2_9_1_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2015.14"},{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.66.4.12"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2014.04.035"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2017.12.029"},{"key":"e_1_2_9_5_1","unstructured":"CDER.Drug and biologic approvals for calendar year 2018|FDA<https:\/\/www.fda.gov\/media\/124807>."},{"key":"e_1_2_9_6_1","unstructured":"Announcement of the National Medical Products Administration on the release of the technical guidelines for accepting overseas clinical trial data of drugs (No. 52 2018)<https:\/\/www.nmpa.gov.cn\/xxgk\/ggtg\/ypggtg\/ypqtggtg\/20180710151401465.html?type=pc&m=>."},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd1382"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)17670-8"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/d41573-020-00146-5"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2023.103737"},{"key":"e_1_2_9_11_1","unstructured":"Complex innovative trial design meeting program|FDA<https:\/\/www.fda.gov\/drugs\/development\u2010resources\/complex\u2010innovative\u2010trial\u2010design\u2010meeting\u2010program>."},{"key":"e_1_2_9_12_1","unstructured":"Commissioner O. of the FDA Patient Engagement Partnerships. 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