Yongming Qu

Eli Lilly · Clinical Research Department

The current COVID-19 pandemic poses numerous challenges for ongoing clinical trials and provides a stress-testing environment for the existing principles and practice of estimands in clinical trials. The pandemic may increase the rate of intercurrent events (ICEs) and missing values, spurring a great deal of discussion on amending protocols and sta...

The current COVID-19 pandemic poses numerous challenges for ongoing clinical trials and provides a stress-testing environment for the existing principles and practice of estimands in clinical trials. The pandemic may increase the rate of intercurrent events (ICEs) and missing values, spurring a great deal of discussion on amending protocols and sta...

One of the central aims in randomized clinical trials is to find well‐validated surrogate endpoints to reduce the sample size and/or duration of trials. Clinical researchers and practitioners have proposed various surrogacy measures for assessing candidate surrogate endpoints. However, most existing surrogacy measures have the following shortcoming...

It has long been noticed that the efficacy observed in small early phase studies is generally better than that observed in later larger studies. Historically, the inflation of the efficacy results from early proof-of-concept studies is either ignored, or adjusted empirically using a frequentist or Bayesian approach. In this article, we systematical...

It has long been noticed that the efficacy observed in small early phase studies is generally better than that observed in later larger studies. Historically, the inflation of the efficacy results from early proof-of-concept studies is either ignored, or adjusted empirically using a frequentist or Bayesian approach. In this article, we systematical...

Generalized linear mixed models (GLMM) are commonly used to model the treatment effect over time while controlling for important clinical covariates. Standard software procedures often provide estimates of the outcome based on the mean of the covariates; however, these estimates will be biased for the true group means in the GLMM. Implementing GLMM...

In this manuscript, we investigate the group mean estimation and prediction for generalized linear models with a subject-wise random effect. Generalized linear models are commonly used to analyze categorical data. The model-based mean for a treatment group usually estimates the response at the mean covariate. It has been argued recently in the lite...

Background To identify possible differences in cardiovascular (CV) risk among different insulin therapies, we performed pre-specified meta-analyses across the clinical program for basal insulin peglispro (BIL), in patients randomized to treatment with BIL or comparator insulin [glargine (IG) or NPH]. Methods One phase 2 (12-week) and 6 phase 3 (26...

For regulatory purposes, in a trial comparing two active treatments, a hypothesis such as noninferiority or superiority must be prespecified even when there is little known about how they compare against each other or when the objective is simply to identify the best. In this paper, we extend an alternative classification methodology, the classific...

This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The six sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative clinical trials design; Modelling and data analysis; Personalized medicine; and Statistical...

Objective: To evaluate the effect and safety of the hyperthermic perfusion cycle of abdominal space with chemotherapy in the treatment of malignant peritoneal effusion induced by gastric carcinoma. Methods: A total of 102 cases of malignant peritoneal effusion were randomly divided into combined (n = 52 ) and single-agent (n = 50) groups. Based on...

With increasing requirements, from both regulatory and scientific community, for pre-specification of details of all analyses prior to unblinding of data in clinical trials, it is critical that one selects the most appropriate statistical model. Selecting a model based on assumption checking either inflates type I error or compromises the statistic...

Objective: To evaluate the efficacy of docetaxel plus cisplatin chemotherapy with concurrent three dimensional radiotherapy (3DCRT) in patients with locally advanced non-small cell lung cancer (NSCLC). Methods: A total of 198 patients with locally advanced lung cancer were divided into the sequential group (102 cases) and the concurrent group (96 c...