{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T01:07:22Z","timestamp":1791594442674,"version":"4.3.4"},"reference-count":28,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,11,17]],"date-time":"2021-11-17T00:00:00Z","timestamp":1637107200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003725","name":"National Research Foundation of Korea","doi-asserted-by":"publisher","award":["NRF\u20102021R1C1C1013177"],"award-info":[{"award-number":["NRF\u20102021R1C1C1013177"]}],"id":[{"id":"10.13039\/501100003725","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This study aimed to develop a model for predicting the completion of clinical trials involving pregnant women using the Cox proportional hazard model and neural network model (DeepSurv) and to compare the predictive performance of both methods. We collected data on 819 clinical trials performed on pregnant women and intervention studies using at least one drug as intervention from 2009 to 2018 from ClinicalTrials.gov. The Cox proportional hazard model and DeepSurv were used to develop models that predict clinical trial completion. The concordance index (C\u2010index) was used to evaluate the predictive performance. The Cox proportional hazard model revealed that a sample size of <jats:italic>n<\/jats:italic> \u2265 329 (hazard ratio [HR] = 0.53), very high human development index (HDI) country (HR = 0.28), abortion (HR = 3.30), labor (HR = 2.16), and iron deficiency anemia (HR = 2.29) were significantly related to the probability of clinical trial completion (all <jats:italic>p<\/jats:italic> value &lt; 0.01). The C\u2010index of the model development dataset and test dataset were 0.72 and 0.73, respectively. DeepSurv model consisted of one hidden layer with 16 nodes. DeepSurv showed the C\u2010index comparable to the Cox proportional hazard model. The C\u2010index of the training dataset and test dataset were 0.76 and 0.72, respectively. Further a nomogram that calculate a probability of clinical trial completion at 1\u00a0year, 3\u00a0years, and 5\u00a0years was developed. Both the Cox proportional hazard model and DeepSurv yielded sufficient predicting performance. We hope that this study will contribute to the execution of future clinical trials in pregnant women.<\/jats:p>","DOI":"10.1111\/cts.13187","type":"journal-article","created":{"date-parts":[[2021,11,4]],"date-time":"2021-11-04T18:18:55Z","timestamp":1636049935000},"page":"691-699","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Predicting completion of clinical trials in pregnant women: Cox proportional hazard and neural network models"],"prefix":"10.1111","volume":"15","author":[{"given":"Bomee","family":"Kim","sequence":"first","affiliation":[{"name":"Graduate School of Clinical Biohealth Ewha Womans University  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun Ji","family":"Jang","sequence":"additional","affiliation":[{"name":"College of Pharmacy CHA University  Pocheon Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hae Ram","family":"Cho","sequence":"additional","affiliation":[{"name":"College of Pharmacy CHA University  Pocheon Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"So Yeon","family":"Kim","sequence":"additional","affiliation":[{"name":"College of Pharmacy CHA University  Pocheon Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji Eun","family":"Jeong","sequence":"additional","affiliation":[{"name":"College of Pharmacy CHA University  Pocheon Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mi Kyoung","family":"Shim","sequence":"additional","affiliation":[{"name":"College of Pharmacy CHA University  Pocheon Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myeong Gyu","family":"Kim","sequence":"additional","affiliation":[{"name":"College of Pharmacy Ewha Womans University  Seoul Korea"},{"name":"Graduate School of Pharmaceutical Sciences Ewha Womans University  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,11,17]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.3138\/ijfab.1.2.5"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2013-004365"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.9989"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clp.2019.02.015"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0b013e3182a9ca67"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajo.12233"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1360-0443.2011.03440.x"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/bioe.12361"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.4155\/cli.11.125"},{"key":"e_1_2_8_11_1","unstructured":"US Food and Drug Administration.Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials Guidance for Industry.https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/pregnant\u2010women\u2010scientific\u2010and\u2010ethical\u2010considerations\u2010inclusion\u2010clinical\u2010trials. 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