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However, as external controls are not always comparable to the trials, direct borrowing without scrutiny may heavily bias the treatment effect estimator. Our paper proposes a data-adaptive integrative framework capable of preventing unknown biases of the external controls. The adaptive nature is achieved by dynamically sorting out a comparable subset of external controls via bias penalization. Our proposed method can simultaneously achieve (a) the semiparametric efficiency bound when the external controls are comparable and (b) selective borrowing that mitigates the impact of the existence of incomparable external controls. Furthermore, we establish statistical guarantees, including consistency, asymptotic distribution and inference, providing Type-I error control and good power. Extensive simulations and two real-data applications show that the proposed method leads to improved performance over the trial-only estimator across various bias-generating scenarios.<\/jats:p>","DOI":"10.1093\/biomet\/asae069","type":"journal-article","created":{"date-parts":[[2024,12,17]],"date-time":"2024-12-17T18:01:46Z","timestamp":1734458506000},"source":"Crossref","is-referenced-by-count":13,"title":["Improving randomized controlled trial analysis via data-adaptive borrowing"],"prefix":"10.1093","volume":"112","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3850-5587","authenticated-orcid":false,"given":"Chenyin","family":"Gao","sequence":"first","affiliation":[{"name":"Department of Statistics, North Carolina State University , 2311 Stinson Drive , Raleigh, North Carolina 27695,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7703-707X","authenticated-orcid":false,"given":"Shu","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Statistics, North Carolina State University , 2311 Stinson Drive , Raleigh, North Carolina 27695,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingyang","family":"Shan","sequence":"additional","affiliation":[{"name":"Eli Lilly & Company, Lilly Corporate Center , 893 Delaware Street , Indianapolis, Indiana 46285,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenyu","family":"Ye","sequence":"additional","affiliation":[{"name":"Eli Lilly & Company, Lilly Corporate Center , 893 Delaware Street , Indianapolis, Indiana 46285,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilya","family":"Lipkovich","sequence":"additional","affiliation":[{"name":"Eli Lilly & Company, Lilly Corporate Center , 893 Delaware Street , Indianapolis, Indiana 46285,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Douglas","family":"Faries","sequence":"additional","affiliation":[{"name":"Eli Lilly & Company, Lilly Corporate Center , 893 Delaware Street , Indianapolis, Indiana 46285,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,12,17]]},"reference":[{"key":"2025062421062477000_asae069-B1","volume-title":"Efficient and Adaptive Inference in Semiparametric Models","author":"Bickel","year":"1998"},{"key":"2025062421062477000_asae069-B2","doi-asserted-by":"crossref","first-page":"723","DOI":"10.1093\/biomet\/asp033","article-title":"Improving efficiency and robustness of the doubly robust estimator for a population mean with incomplete data","volume":"96","author":"Cao","year":"2009","journal-title":"Biometrika"},{"key":"2025062421062477000_asae069-B3","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1080\/01621459.2015.1123157","article-title":"Constrained maximum likelihood estimation for model calibration using summary-level information from external big data sources","volume":"111","author":"Chatterjee","year":"2016","journal-title":"J. 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