A5102764594- Statistical Methods in Clinical Trials
- Optimal Experimental Design Methods
- Health Systems, Economic Evaluations, Quality of Life
- Cerebrovascular and Carotid Artery Diseases
- Acute Ischemic Stroke Management
- Dementia and Cognitive Impairment Research
- Alzheimer's disease research and treatments
- Statistical Methods and Bayesian Inference
- Gene expression and cancer classification
- Health disparities and outcomes
- Anesthesia and Sedative Agents
- Health Promotion and Cardiovascular Prevention
- Optical Imaging and Spectroscopy Techniques
- Airway Management and Intubation Techniques
- MRI in cancer diagnosis
- Intracerebral and Subarachnoid Hemorrhage Research
- Neurological Disease Mechanisms and Treatments
- Pharmaceutical studies and practices
- Traumatic Brain Injury and Neurovascular Disturbances
- Traditional Chinese Medicine Studies
- Sympathectomy and Hyperhidrosis Treatments
- Ginkgo biloba and Cashew Applications
- Cytomegalovirus and herpesvirus research
- Artificial Intelligence in Education
- Moyamoya disease diagnosis and treatment
Northwest Women's and Children's Hospital
2024
Beijing Hospital
2020-2023
Hubei University of Medicine
2014-2020
Bright Cloud International (United States)
2019
Logistics University of People's Armed Police Force
2019
Second Affiliated Hospital of Zhejiang University
2018-2019
Academy of Military Medical Sciences
2018-2019
Doctors Company (United States)
2007-2017
Qingdao Municipal Hospital
2017
Changzhou No.2 People's Hospital
2017
Abstract Background New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with novel proposed mechanism of action. The first phase 3 clinical trial GV-971 has been completed in China. Methods We conducted 3, double-blind, placebo-controlled participants mild-to-moderate AD to assess efficacy and safety. Participants were randomized placebo or (900 mg) 36 weeks. primary outcome was the drug-placebo difference change...
Abstract There is considerable interest in methods that use accumulated data to modify trial sample size. However, size re-estimation group sequential designs has been controversial. We describe a method for at the penultimate stage of design achieves specified power against an alternative hypothesis corresponding current point estimate treatment effect. Key Words: Adaptive designBrownian motionConditional powerMarkov processSample re-estimationSequential designTransition function...
ABSTRACT Sample size re‐estimation (SSR) is perhaps the most used adaptive procedure in both frequentist and Bayesian designs for clinical trials. The primary focus of all current SSR procedures type I error control. We propose a hybrid frequentist‐Bayesian approach that focuses on optimizing operating characteristics (OC), which uses simulations to investigate associated OC adjusts accordingly. incorporates predictive power into framework SSR. Simulations show can substantially outperform...
Summary Two-arm group sequential designs have been widely used for over 40 years, especially studies with mortality endpoints. The natural generalization of such to trials multiple treatment arms and a common control (MAMS designs) has, however, implemented rarely. While the statistical methodology this extension is clear, main limitation has an efficient way perform computations. Past efforts were hampered by algorithms that computationally explosive. With increasing interest in adaptive...
Methods for controlling the type‐1 error of an adaptive group sequential trial were developed in seminal papers by Cui, Hung, and Wang (Biometrics, 1999), Lehmacher Wassmer Müller Schäfer 2001). However, corresponding solutions equally important related problem parameter estimation at end have not been completely satisfactory. In this paper, a method is provided computing two‐sided confidence interval having exact coverage, along with point estimate that median unbiased primary efficacy...
A method is proposed for modifying a group-sequential clinical trial by restricting future enrollment to subgroup and possibly altering the sample size of subgroup, based on an interim analysis data already obtained. The provides strong control type 1 error without requiring prespecification list possible subgroups or decision rule selecting among them. Nevertheless, regulatory submissions it recommended that be prespecified. applied large cardiology in which are prespecified rules selection...
Abstract Background Intima-media thickness (IMT) and small dense low-density lipoprotein cholesterol (sdLDL-C) have been reported to be related atherosclerosis stroke. This study is trying explore the association between IMT sdLDL-C in Chinese acute ischaemic stroke (AIS) subjects. Methods enrolled total 368 consecutive AIS patients 165 non-AIS controls from November 2016 February 2019. Mean carotid plaques were measured by using ultrasonography method. Blood glucose lipid parameters an...
We propose an adaptive sequential testing procedure for the selection and of multiple treatment options, such as dose/regimen, different drugs, sub-populations, endpoints, or a mixture them in seamlessly combined phase II/III trial. The is to be made at end 2 stage. Unlike many published literature, rule not required "select best", does need pre-specified, which provides flexibility allows trial investigators use any efficacy safety information/criteria, surrogate intermediate endpoint make...
The failure rates of phase 3 trials are high. Incorrect sample size due to uncertainty effect could be a critical contributing factor. Adaptive sequential design (ASD), which may include one or more re-estimations (SSR), has been popular approach for dealing with such uncertainties. operating characteristics (OCs) ASD, including the unconditional power and mean size, can substantially affected by many factors, planned interim analysis schedule choice boundaries rules analysis. We propose...
Abstract Non‐inferiority designs are growing in importance as a strategy for comparing new drugs with established therapies. Because it is not possible to show that drug and the therapy have identical efficacy profiles, non‐inferiority trials designed demonstrate inferior an (the ‘control’) relative prespecified ‘non‐inferiority margin’. No objective principle guides choice of margin, controversies about margin have, some cases, had important consequences development. We argue these arisen...
The performance of a new monitor for the depth anesthesia (DOA), Depth Anesthesia Index (Ai) based on sample entropy (SampEn), 95% spectral edge frequency (95%SEF), and burst suppression ratio (BSR) was evaluated compared to Bispectral (BIS) during total intravenous (TIVA). 144 patients in six medical centers were enrolled. General induced with stepwise-increased target-controlled infusion (TCI) propofol until loss consciousness (LOC). During surgery titrated according BIS. Both Ai BIS...
Background Women comprise almost 50% of patients undergoing transcatheter aortic valve replacement (TAVR) and previous studies have indicated higher rates procedural complications bleeding in women compared to men. It is unknown whether men demonstrate a differential response bivalirudin versus unfractionated heparin (UFH) TAVR. We sought evaluate outcomes by sex type anticoagulant from the Bivalirudin Versus Heparin Anticoagulation Transcatheter Aortic Valve Replacement (BRAVO‐3) trial...
We propose a Markov process theory-based adaptive sequential testing procedure for multiple comparisons. The can be used confirmative trials involving multi-comparisons, including dose selection or population enrichment. Dose subpopulation and sample size modification made at any interim analysis. Type I error control is exact.
A method of testing for noninferiority followed by superiority in an adaptive group sequential design is presented. The permits a data-dependent increase sample size without any inflation type-1 error. Closed-form expressions computing conditional power and the required to achieve desired are derived. new statistical performing inference on primary efficacy parameter used obtain p-value, median-unbiased point estimate confidence interval parameter. For normal endpoints with known variance,...
Life expectancy of the elderly is a significant problem in China, and it changes not only health care, but also pension. This study used tracking data from Chinese Urban Rural Elderly Population Survey to calculate age-specific Active Expectancy (ALE) population aged 60 years over. For analysis, this was divided into different sub-populations according gender, census register region. The main conclusions our are as follows: 1) quality life for males may be greater than that females; 2) There...
Single-arm phase II trials are very common in oncology. A fixed sample trial may lack sufficient power if the true efficacy is less than assumed one. Adaptive designs have been proposed literature. We propose a Simon's design based, adaptive sequential design. most used for single-arm oncology trials. prominent feature of that it minimizes size when there no clinically meaningful efficacy. identify as special group Established methods re-estimation (SSR) can be readily applied to Simulations...
This study used the data from Chinese Urban and Rural Elderly Population Survey to analyze correlations among self-rated health of elderly people, demographic factors chronic diseases. The results revealed that in comparing younger individuals vs older individuals, urban rural elderly, man women, with fewer diseases more diseases, former’s tended be good, while latter bad. In addition, over time, individuals’ improve. paper further studied high blood pressure, heart disease, arthritis, neck...
We propose an adaptive sequential testing procedure for clinical trials that test the efficacy of multiple treatment options, such as dose/regimen, different drugs, sub-populations, endpoints, or a mixture them in one trial. At any interim analyses, sample size re-estimation can be conducted, and option dropped lack unsatisfactory safety profile. Inference after trial, including p-value, conservative point estimate confidence intervals, are provided.