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3. Considerations for Master Protocols Using External Controls

Author

Chen, Jie, Xiaoyun, Li, Chengxing, Lu, Yuan, Sammy, Yung, Godwin, Ye, Jingjing, Tian, Hong, and Lin, Jianchang

Subjects
Statistics - Applications
Abstract

There has been an increasing use of master protocols in oncology clinical trials because of its efficiency and flexibility to accelerate cancer drug development. Depending on the study objective and design, a master protocol trial can be a basket trial, an umbrella trial, a platform trial, or any other form of trials in which multiple investigational products and/or subpopulations are studied under a single protocol. Master protocols can use external data and evidence (e.g., external controls) for treatment effect estimation, which can further improve efficiency of master protocol trials. This paper provides an overview of different types of external controls and their unique features when used in master protocols. Some key considerations in master protocols with external controls are discussed including construction of estimands, assessment of fit-for-use real-world data, and considerations for different types of master protocols. Similarities and differences between regular randomized controlled trials and master protocols when using external controls are discussed. A targeted learning-based causal roadmap is presented which constitutes three key steps: (1) define a target statistical estimand that aligns with the causal estimand for the study objective, (2) use an efficient estimator to estimate the target statistical estimand and its uncertainty, and (3) evaluate the impact of causal assumptions on the study conclusion by performing sensitivity analyses. Two illustrative examples for master protocols using external controls are discussed for their merits and possible improvement in causal effect estimation.

Published
2023

4. Research progress on the molecular genetics and neuroscience of congenital cranial dysinnervation disorders

Author

Ye Jingjing, Wang Mengdi, and Shi Xuefeng

Subjects
congenital cranial dysinnervation disorders, congenital fibrosis of the extraocular muscles, congenital ptosis, duane's retraction syndrome, horizontal gaze palsy with progressive scoliosis, congenital facial weakness, Ophthalmology, RE1-994
Abstract

Congenital cranial dysinnervation disorders(CCDDs)are a group of diseases with congenital non-progressive developmental abnormalities or absence of one or more cranial nerves, resulting in primary or secondary abnormalities of cranial nerves innervating the extraocular muscles. CCDDs can be sporadic or hereditary, and may be accompanied by systemic abnormalities. In recent years, with the research progress of neuropathology, neuroimaging, and genetics, it has not only been clarified that the cause of eye movement disorder in CCDDs is neurogenic, but also been found the pathogenic genes of CCDDs, including SALL4, HOXA1, KIF21A, PHOX2A, TUBB3, and HOXB1, etc. In this review, the relevant domestic and international literatures on the molecular genetics and neuroscience of CCDDs in recent years are reviewed, aiming to address how the causing gene mutations of CCDDs affect brain neural development and further lead to congenital abnormal cranial nerve innervation, in order to provide references for the clinical and basic research of CCDDs.

Published
2024
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5. 3D Simulation of Multi-cathode Spot Jets in Vacuum Arc

Author

Yang, Peixuan, Yuan, Zhao, Ye, Jingjing, Liu, Liming, Gui, Xianxian, Liu, Xueliang, Pan, Yuan, Angrisani, Leopoldo, Series Editor, Arteaga, Marco, Series Editor, Chakraborty, Samarjit, Series Editor, Chen, Jiming, Series Editor, Chen, Shanben, Series Editor, Chen, Tan Kay, Series Editor, Dillmann, Rüdiger, Series Editor, Duan, Haibin, Series Editor, Ferrari, Gianluigi, Series Editor, Ferre, Manuel, Series Editor, Jabbari, Faryar, Series Editor, Jia, Limin, Series Editor, Kacprzyk, Janusz, Series Editor, Khamis, Alaa, Series Editor, Kroeger, Torsten, Series Editor, Li, Yong, Series Editor, Liang, Qilian, Series Editor, Martín, Ferran, Series Editor, Ming, Tan Cher, Series Editor, Minker, Wolfgang, Series Editor, Misra, Pradeep, Series Editor, Mukhopadhyay, Subhas, Series Editor, Ning, Cun-Zheng, Series Editor, Nishida, Toyoaki, Series Editor, Oneto, Luca, Series Editor, Panigrahi, Bijaya Ketan, Series Editor, Pascucci, Federica, Series Editor, Qin, Yong, Series Editor, Seng, Gan Woon, Series Editor, Speidel, Joachim, Series Editor, Veiga, Germano, Series Editor, Wu, Haitao, Series Editor, Zamboni, Walter, Series Editor, Tan, Kay Chen, Series Editor, Yang, Qingxin, editor, Li, Zewen, editor, and Luo, An, editor

Published
2024
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12. Extent of Safety Database in Pediatric Drug Development: Types of Assessment, Analytical Precision, and Pathway for Extrapolation through On-Target Effects

Author

Gamalo, Margaret, Zhao, Yihua, Gao, Aijun, Ye, Jingjing, DeMasi, Ralph, Eshida, Eiji, Choi, YJ, and Nelson, Robert

Subjects
Statistics - Applications
Abstract

Pediatric patients should have access to medicines that have been appropriately evaluated for safety and efficacy. Given this goal of revised labelling, the adequacy of the pediatric clinical development plan and resulting safety database must inform a favorable benefit-risk assessment for the intended use of the medicinal product. While extrapolation from adults can be used to support efficacy of drugs in children, there may be a reluctance to use the same approach in safety assessments, wiping out potential gains in trial efficiency through a reduction of sample size. To address this reluctance, we explore safety review in pediatric trials, including factors affecting these data, specific types of safety assessments, and precision on the estimation of event rates for specific adverse events (AEs) that can be achieved. In addition, we discuss the assessments which can provide a benchmark for the use of extrapolation of safety that focuses on on-target effects. Finally, we explore a unified approach for understanding precision using Bayesian approaches as the most appropriate methodology to describe/ascertain risk in probabilistic terms for the estimate of the event rate of specific AEs.

Published
2022

22. Differences in clinical characteristics and outcomes between patients with grade 3a and grades 1–2 follicular lymphoma: a real-world multicenter study

Author

Zha, Jie, Chen, Qinwei, Ye, Jingjing, Yu, Haifeng, Yi, Shuhua, Zheng, Zhong, Xu, Wei, Li, Zhifeng, Ping, Lingyan, He, Xiaohua, Zhang, Liling, Li, Caixia, Xie, Ying, Chen, Feili, Sun, Xiuhua, Su, Liping, Zhang, Huilai, Fan, Liyuan, Lin, Zhijuan, Yang, Haiyan, Zhao, Weili, Qiu, Lugui, Li, Zhiming, Song, Yuqin, and Xu, Bing

Published
2023
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24. Particle Simulation of Near-Cathode Sheath in Vacuum Arc

Author

Shi, Qilin, Yang, Peixuan, Ye, Jingjing, Liu, Xueliang, Jiang, Wei, Yuan, Zhao, Angrisani, Leopoldo, Series Editor, Arteaga, Marco, Series Editor, Panigrahi, Bijaya Ketan, Series Editor, Chakraborty, Samarjit, Series Editor, Chen, Jiming, Series Editor, Chen, Shanben, Series Editor, Chen, Tan Kay, Series Editor, Dillmann, Rüdiger, Series Editor, Duan, Haibin, Series Editor, Ferrari, Gianluigi, Series Editor, Ferre, Manuel, Series Editor, Hirche, Sandra, Series Editor, Jabbari, Faryar, Series Editor, Jia, Limin, Series Editor, Kacprzyk, Janusz, Series Editor, Khamis, Alaa, Series Editor, Kroeger, Torsten, Series Editor, Li, Yong, Series Editor, Liang, Qilian, Series Editor, Martín, Ferran, Series Editor, Ming, Tan Cher, Series Editor, Minker, Wolfgang, Series Editor, Misra, Pradeep, Series Editor, Möller, Sebastian, Series Editor, Mukhopadhyay, Subhas, Series Editor, Ning, Cun-Zheng, Series Editor, Nishida, Toyoaki, Series Editor, Oneto, Luca, Series Editor, Pascucci, Federica, Series Editor, Qin, Yong, Series Editor, Seng, Gan Woon, Series Editor, Speidel, Joachim, Series Editor, Veiga, Germano, Series Editor, Wu, Haitao, Series Editor, Zamboni, Walter, Series Editor, Zhang, Junjie James, Series Editor, Yang, Qingxin, editor, Li, Jian, editor, Xie, Kaigui, editor, and Hu, Jianlin, editor

Published
2023
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30. UAV Deployment Optimization for Secure Precise Wireless Transmission

Author

Shen, Tong, Xia, Guiyang, Ye, Jingjing, Gu, Lichuan, Zhou, Xiaobo, and Shu, Feng

Subjects
Electrical Engineering and Systems Science - Signal Processing
Abstract

This paper develops an unmanned aerial vehicle (UAV) deployment scheme in the context of the directional modulation-based secure precise wireless transmissions (SPWTs), where the optimal UAV position for the SPWT is derived to maximum the secrecy rate (SR) without injecting any artificial noise (AN) signaling. To be specific, the proposed scheme reveals that the optimal position of UAV for maximizing the SR performance has to be placed at the null space of Eves channel, which impels the received energy of the confidential message at the unintended receiver deteriorating to zero whilst benefits the one at the intended receiver achieving its maximum value. Finally, simulation results verify the optimality of our proposed scheme in terms of the achievable SR performance.

Published
2021

44. Ultrasound-guided radiofrequency ablation combined with puncture and aspiration for intrauterine treatment of fetal sacrococcygeal cystic solid teratoma: a case report and literature review

Author

Zou, Qingguo, primary, Kan, Guangjuan, additional, Han, Yutian, additional, Wang, Minyan, additional, Fu, Xiaofeng, additional, Liu, Shanshan, additional, Ye, Jingjing, additional, Xiang, Qingyi, additional, Luo, Qiong, additional, and Zhu, Jiang, additional

Published
2024
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