{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T11:56:20Z","timestamp":1781697380970,"version":"3.54.5"},"reference-count":13,"publisher":"Becaris Publishing Limited","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:p>\n                    <jats:bold>Aim:<\/jats:bold>\n                    We sought to directly compare contemporaneous real-world (RW) and randomized controlled trial (RCT) control arms to assess the feasibility of utilizing RW controls in early breast cancer treatment.\n                    <jats:bold>Materials &amp; methods:<\/jats:bold>\n                    Women with human epidermal growth factor receptor 2-negative high-risk breast cancer receiving adjuvant docetaxel, doxorubicin and cyclophosphamide for six cycles between 29 May 2007 and 21 November 2013 were included, mirroring the control arm and study timeframe from our reference trial \u2018Anthracyclines in Early Breast Cancer: The ABC Trials\u2019. Structured data was extracted from the iKnowMed electronic medical record system, which included both RW and trial patients allowing for their direct comparison. Propensity scores were used for baseline characteristic balancing, and Kaplan\u2013Meier analysis was conducted.\n                    <jats:bold>Results:<\/jats:bold>\n                    In the final sample of 306 patients (153 per arm drawn from 155 RCT patients and 703 RW patients in the study timeframe), the matching process yielded balanced cohorts along available covariates. Kaplan\u2013Meier curves and disease-free survival distributions did not suggest significant differences between RW and trial arms (log rank\n                    <jats:italic toggle=\"yes\">p<\/jats:italic>\n                    \u00a0=\u00a00.98).\n                    <jats:bold>Conclusion:<\/jats:bold>\n                    Despite limitations, including the use of structured data only, the study suggests that RW data could have served as a synthetic control in this setting.\n                  <\/jats:p>","DOI":"10.57264\/cer-2025-0143","type":"journal-article","created":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T11:21:26Z","timestamp":1780053686000},"source":"Crossref","is-referenced-by-count":0,"title":["Directly comparing randomized and real-world controls in adjuvant breast cancer"],"prefix":"10.57264","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5617-577X","authenticated-orcid":false,"given":"Brigham","family":"Walker","sequence":"first","affiliation":[{"name":"Department of Health Policy and Management, Tulane University Celia Scott Weatherhead School of Public Health, LA 70112, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marley","family":"Boyd","sequence":"additional","affiliation":[{"name":"TriNetX, MA 02140, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Silver","sequence":"additional","affiliation":[{"name":"Genesis Research, NJ 07030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junxin","family":"Shi","sequence":"additional","affiliation":[{"name":"Ontada, MA 02109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Purva","family":"Bulsara","sequence":"additional","affiliation":[{"name":"Ontada, MA 02109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nino","family":"Balanchivadze","sequence":"additional","affiliation":[{"name":"Virginia Oncology Associates, US Oncology Network, VA 23502, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas J","family":"Robert","sequence":"additional","affiliation":[{"name":"Ontada, MA 02109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"36897","reference":[{"issue":"12","key":"e_1_3_6_2_2","doi-asserted-by":"crossref","first-page":"1704","DOI":"10.1016\/j.annonc.2020.08.2106","article-title":"A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials","volume":"31","author":"Amiri-Kordestani L","year":"2020","unstructured":"Amiri-Kordestani L, Xie D, Tolaney SM A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Ann. Oncol. 31(12), 1704\u20131708 (2020).","journal-title":"Ann. Oncol."},{"issue":"15","key":"e_1_3_6_3_2","doi-asserted-by":"crossref","first-page":"e13102","DOI":"10.1200\/JCO.2020.38.15_suppl.e13102","article-title":"Evaluating progression-free survival in black and white women with triple-negative breast cancer in pooled clinical trials from a synthetic control database (SCD) and real-world electronic medical records (EMR)","volume":"38","author":"Watson ML","year":"2020","unstructured":"Watson ML, Holcomb K, Newman L Evaluating progression-free survival in black and white women with triple-negative breast cancer in pooled clinical trials from a synthetic control database (SCD) and real-world electronic medical records (EMR). J. Clin. Oncol. 38(Suppl. 15), e13102 (2020).","journal-title":"J. Clin. Oncol."},{"issue":"15","key":"e_1_3_6_4_2","doi-asserted-by":"crossref","first-page":"e20521","DOI":"10.1200\/JCO.2020.38.15_suppl.e20521","article-title":"Exploring the validity of a synthetic control arm (SCA) for augmentation or replacement of a randomized control in difficult-to-study indications: a case study in relapsed or refractory multiple myeloma (R\/R MM)","volume":"38","author":"Davi R","year":"2020","unstructured":"Davi R, Yin X, Stewart M. Exploring the validity of a synthetic control arm (SCA) for augmentation or replacement of a randomized control in difficult-to-study indications: a case study in relapsed or refractory multiple myeloma (R\/R MM). J. Clin. Oncol. 38(Suppl. 15), e20521 (2020).","journal-title":"J. Clin. Oncol."},{"issue":"15","key":"e_1_3_6_5_2","doi-asserted-by":"crossref","first-page":"8047","DOI":"10.1200\/JCO.2019.37.15_suppl.8047","article-title":"Project Switch: lenalidomide and dexamethasone (Len-Dex) as a potential synthetic control arm (SCA) in relapsed or refractory multiple myeloma (rrMM)","volume":"37","author":"Kanapuru B","year":"2019","unstructured":"Kanapuru B, Gong Y, Mishra-Kalyani PS Project Switch: lenalidomide and dexamethasone (Len-Dex) as a potential synthetic control arm (SCA) in relapsed or refractory multiple myeloma (rrMM). J. Clin. Oncol. 37(Suppl. 15), 8047 (2019).","journal-title":"J. Clin. Oncol."},{"issue":"4","key":"e_1_3_6_6_2","doi-asserted-by":"crossref","first-page":"376","DOI":"10.1016\/j.annonc.2021.12.015","article-title":"External control arms in oncology: current use and future directions","volume":"33","author":"Mishra-Kalyani PS","year":"2022","unstructured":"Mishra-Kalyani PS, Amiri Kordestani L, Rivera DR External control arms in oncology: current use and future directions. Ann. Oncol. 33(4), 376\u2013383 (2022).","journal-title":"Ann. Oncol."},{"issue":"10","key":"e_1_3_6_7_2","doi-asserted-by":"crossref","first-page":"1426","DOI":"10.1001\/jamaoncol.2024.3466","article-title":"Externally controlled studies using real-world data in patients with hematological cancers: a systematic review","volume":"10","author":"Hermans SJF","year":"2024","unstructured":"Hermans SJF, van der Maas NG, van Norden Y Externally controlled studies using real-world data in patients with hematological cancers: a systematic review. JAMA Oncol. 10(10), 1426\u20131436 (2024).","journal-title":"JAMA Oncol."},{"key":"e_1_3_6_8_2","first-page":"e2300317","article-title":"Framework for the use of external controls to evaluate treatment outcomes in precision oncology trials","volume":"8","author":"Siu DHW","year":"2024","unstructured":"Siu DHW, Lin FPY, Cho D Framework for the use of external controls to evaluate treatment outcomes in precision oncology trials. JCO Precis. Oncol. 8, e2300317 (2024).","journal-title":"JCO Precis. Oncol."},{"issue":"4","key":"e_1_3_6_9_2","doi-asserted-by":"crossref","first-page":"806","DOI":"10.1002\/cpt.1723","article-title":"Beyond randomized clinical trials: use of external controls","volume":"107","author":"Schmidli H","year":"2020","unstructured":"Schmidli H, H\u00e4ring DA, Thomas M, Cassidy A, Weber S, Bretz F. Beyond randomized clinical trials: use of external controls. Clin. Pharmacol. Ther. 107(4), 806\u2013816 (2020).","journal-title":"Clin. Pharmacol. Ther."},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.57264\/cer-2023-0176"},{"issue":"68","key":"e_1_3_6_11_2","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1093\/jncimonographs\/lgae046","article-title":"On the use of external controls in clinical trials","volume":"2025","author":"Nu\u00f1o MM","year":"2025","unstructured":"Nu\u00f1o MM, Pugh SL, Ji L, Piao J, Dignam JJ, Steingrimsson JA. On the use of external controls in clinical trials. J. Natl Cancer Inst. Monogr. 2025(68), 30\u201334 (2025).","journal-title":"J. Natl Cancer Inst. Monogr."},{"key":"e_1_3_6_12_2","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1200\/CCI.20.00125","article-title":"Comparisons of real-world time-to-event end points in oncology research","volume":"5","author":"Walker B","year":"2021","unstructured":"Walker B, Boyd M, Aguilar K Comparisons of real-world time-to-event end points in oncology research. JCO Clin. Cancer Inform. 5, 45\u201346 (2021).","journal-title":"JCO Clin. Cancer Inform."},{"issue":"34","key":"e_1_3_6_13_2","doi-asserted-by":"crossref","first-page":"5381","DOI":"10.1200\/JCO.2006.06.5391","article-title":"Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer","volume":"24","author":"Jones SE","year":"2006","unstructured":"Jones SE, Savin MA, Holmes FA Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer. J. Clin. Oncol. 24(34), 5381\u20135387 (2006).","journal-title":"J. Clin. Oncol."},{"key":"e_1_3_6_14_2","unstructured":"SAS version 9.4. SAS (Statistical Analysis System) Institute Incorporated NC USA. https:\/\/support.sas.com\/software\/94\/"}],"container-title":["Journal of Comparative Effectiveness Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/becarispublishing.com\/doi\/pdf\/10.57264\/cer-2025-0143","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T11:20:46Z","timestamp":1781695246000},"score":1,"resource":{"primary":{"URL":"https:\/\/becarispublishing.com\/doi\/10.57264\/cer-2025-0143"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6]]},"references-count":13,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["10.57264\/cer-2025-0143"],"URL":"https:\/\/doi.org\/10.57264\/cer-2025-0143","relation":{},"ISSN":["2042-6305","2042-6313"],"issn-type":[{"value":"2042-6305","type":"print"},{"value":"2042-6313","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6]]},"article-number":"e250143"}}