International Journal of Clinical Biostatistics and Biometrics is an international, peer reviewed, open access journal on conceptual, constructive, experimental, computational, investigational, or theoretical work in all areas of biostatistics and biometrics. The Journal provides the authors with a great platform for publication of their work and for the exchange of their ideas. We aim to publish highest quality clinical content via open access platform providing the readers without charge, immediate and unlimited access.

International Journal of Clinical Biostatistics and Biometrics publishes articles on Data Modeling, Bayesian Probability, Bioinformatic Methods, Biological Experimental Data Modeling, Biostatistic Theory and Methods, Climate and Environmental Data Modeling, Clinical Study Design and Analysis, Clinical Trials and Assessment Methods, Computational Biology, Distribution and Modeling of Disease Dynamics, Epidemiological Data Modeling and Analysis, Evolution and Population Genetics, Genetics and Genetic Epidemiology, Health Services Research and Assessment, Mathematical Biology, Medical Imaging Data Modeling, Pain Management Anesthesia, Public Health and Healthcare Evaluation, Public Health Policy Research, Statistical Computation and Applications, etc. All articles published in the journal are subject to a rigorous peer review process.

Journal Information

Title: International Journal of Clinical Biostatistics and Biometrics

ISSN: 2469-5831

Editor-in-chief: James Michael Hardin

NLM title abbreviation: Int J Clin Biostat Biom

ISO abbreviation: Int J Clin Biostat Biom

Other titles: IJCBB

Category: Public health/Biological Science

DOI: 10.23937/2469-5831

Peer review: Double blind

Review speed: 3 weeks

Fast-track review: 10 days

Publication format (s): Electronic and print

Publication policy: Open Access; COPE guide

Publication type(s): Periodicals

Publisher: ClinMed International Library

Country of publication: USA

Language: English

Contact email:

Articles Search by   Keyword   |   Journal title   |   Author name   |   DOI


 Open Access DOI:10.23937/2469-5831/1510033

Multiobjective Optimal Control of the COVID Virus Outbreak

Lakshmi Sridhar

Article Type: Research Article | First Published: January 20, 2021

The number of fatalities caused by the COVID virus is not only extremely high but also increasing at an alarming rate. The many strategies that are being used throughout the world, to control the pandemic, are being overwhelmed mercilessly by the global pandemic. In this paper three different optimization strategies are used to determine the best strategy that can minimize the damage. It is also demonstrated that for one value of the number of infected subjects two values of recovered and perish...

 Open Access DOI:10.23937/2469-5831/1510032

Changes in Mobility during COVID-19 as a Response to Government Imposed Restrictions: A Multiple Regression Analysis for the Top Five Populous U.S States

Eitan Flor, Florence George and BM Golam Kibria

Article Type: Original Article | First Published: November 14, 2020

With the rise of the COVID-19 pandemic, several changes occurred in the lifestyle and habits of human life. These include various voluntary and mandatory governmental restrictions, limiting social interaction by encompassing social distancing, travel limitations, social gatherings, personal mobility, as well as closures and reduced capacities in sectors such as retail, restaurants, and the entertainment industry. The purpose of the restrictions ideally intended to reduce the transmission rate of...

 Open Access DOI:10.23937/2469-5831/1510031

A New Two Parameter Biased Estimator for the Unrestricted Linear Regression Model: Theory, Simulation and Application

Issam Dawoud and BM Golam Kibria

Article Type: Original Article | First Published: November 11, 2020

This paper proposes a new biased estimator for estimating the regression parameters for the multiple linear regression models when the regressors are correlated. Theoretical comparisons and simulations results show that, the proposed estimator performs better than other existing estimators under some conditions in the smaller mean squares error sense. A real-life dataset is analyzed to illustrate the findings of the paper. The ordinary least squares (OLS) estimator is the best linear unbiased es...

 Open Access DOI:10.23937/2469-5831/1510030

Two-stage Adaptive Biomarker-Targeted Clinical Trial Design: Non-Parametric Bayesian and MLE Approaches

Huiding Chen, Ao Yuan and Ming T Tan

Article Type: Research Article | First Published: October 14, 2020

Biomarker targeted two-stage adaptive design is used increasingly in early-stage clinical trials in a variety of therapeutic areas including oncology, where the sample size of the trial is re-estimated based on the first stage data. In such trials often the sample size is moderate, and so incorporating prior information and using robust methods are desirable. In this article, to improve upon existing methods using parametric normal models, we propose a nonparametric Bayesian approach for designi...

 Open Access DOI:10.23937/2469-5831/1510029

Pulmonary Thromboembolism in COVID-19: Proposal for a Scoring System for Diagnosis

Alberto Saraiva Tibúrcio, MD and Fabíola Curvello Leite Tibúrcio, MD

Article Type: Patient Care | First Published: August 26, 2020

Pulmonary thromboembolism is a clinical condition that is difficult to diagnose and highly lethal if not diagnosed and treated in time. The COVID-19 pandemic has greatly increased the incidence of PTE in patients affected by the SARS-CoV-2 virus. On July 16, 2020, at the time of making this manuscript, the COVID-19 pandemic, a disease caused by the new coronavirus SARS-CoV-2, has already reached more than 13.7 million confirmed cases on a global scale and about six thousand deaths daily, totalin...

 Open Access DOI:10.23937/2469-5831/1510028

Bridging Strategies for In Vitro Diagnostic Clinical Trials in a New Region

Robert Magari, PhD, Mohamad Hasan, PhD and Karen Lo

Article Type: Original Article | First Published: July 10, 2020

The need for multiregional clinical trials for in vitro diagnostic devices and extrapolating results in a new region is increasing in recent years. In this paper we are providing strategies for consideration of bridging studies for the two most common types of clinical trials for in vitro diagnostic, method comparison and diagnostic clinical performance trials. Bridging studies should be considered when the expected agreement in the new region is inferior to the agreement in the original trial. ...

 Open Access DOI:10.23937/2469-5831/1510027

Application of Hierarchical Polynomial Regression Models to Predict Transmission of COVID-19 at Global Level

Matthew Ekum and Adeyinka Ogunsanya

Article Type: Research Article | First Published: June 27, 2020

COVID-19 is the disease caused by a novel coranavirus, which outbreak started in Wuhan community of China during December, 2019. World Health Organisation (WHO) started reporting cases of COVID-19 on 21st January. In this research, we aimed at forecasting new cases of COVID-19 per day, using data collected from 21st January to 10th June, 2020, spanning 142 days, by fitting polynomial models. Different model selection criteria were used to determine the most appropriate model among assumed models...

 Open Access DOI:10.23937/2469-5831/1510026

The Basic Four Measures and their Derivates in Dichotomous Diagnostic Tests

Tadeusz R Ostrowski, MD and Tadeusz Ostrowski, PhD

Article Type: Original Article | First Published: June 05, 2020

The paper focuses on four basic statistics of dichotomous diagnostic tests, i.e. sensitivity, specificity, positive and negative predictive value, and some of their derivates, like Youden index and predictive summary index, and on further derivates of these derivates, i.e. Matthews correlation coefficient (or Yule phi), chi squared test and Cramer’s V coefficient. The paper contains also the necessary and sufficient conditions for a test to be invalid, to be uninformative and the necessary con...

 Open Access DOI:10.23937/2469-5831/1510025

Factors Influencing Resident Research: Evidence from a 10-Year Cohort

Adnan N Kiani, Babatunde Olaiya, Richard Berg and Ateeq Rehman

Article Type: Research Article | First Published: March 19, 2020

ACGME has put great emphasis on scholarly activity during residency, yet ACGME has not been able to identify gaps in achieving these goals. We possess longitudinal data for the last 10 years across our residency training programs. With this, we have identified missing gaps as well as propose interventions to address gaps. The research design employs utilizing a standardized research instrument (questionnaire), answered by every resident at the onset and completion of residency training. This que...

 Open Access DOI:10.23937/2469-5831/1510024

Nonparametric Method for Estimation of Controlled Correlations in Studies of VEGF-Hypoxia Relationship

Maxim S Kodryan, Anna V Kuznetsova, Luidmila L Klimenko, Aksana N Mazilina, Ivan V Baskakov and Oleg V Senko

Article Type: Research Article | First Published: March 04, 2020

It is known that vascular endothelial growth factor (VEGF) expression is a response to hypoxia. On the other hand hypoxia may be detected by oximetry parameters including venous CO-oximetry indices or corresponding partial pressures of O2 and CO2. However significant correlation ties between VEGF levels and oximetry parameters were not found in groups of patients with ischemic stroke and transient ischemic attack. At that some effect related to the relationship between VEGF and sO2 was observed ...

 Open Access DOI:10.23937/2469-5831/1510023

A Signal Detection Analysis of World Health Organization’s Pharmacovigilance Database

Yeqian Liu

Article Type: Original Article | First Published: December 14, 2019

Pharmacovigilance is the primary method used to identify hazards associated with medicinal products. Using generalized likelihood ratio tests, we examed the adverse reaction signals of the drug class Monoamine oxidase inhibitors (MAOIs) from World Health Organization’s Pharmacovigilance Database. The proposed test procedure has the ability of detecting adverse reactions of multiple drugs simultaneously. Our findings sugggest there are 23 common Adverse reaction signals detected within this dru...

 Open Access DOI:10.23937/2469-5831/1510022

Child Mortality: A Comparative Study of Some Developing Countries in the World

Ilker Etikan, Ogunjesa Babatope, Kabiru Bala and Savas Ilgi

Article Type: Research Article | First Published: September 30, 2019

According to the United Nations Sustainable Development Goals, countries all over the world are expected to create a healthy living environment for the populace most especially the vulnerable population of which children are examples. Despite the reducing trend in the under-five mortality rate in some developing nations, some nations still have a high record of under-five mortality. This study adopted the use of a One-way Analysis of Variance (ANOVA) to evaluate any significant difference in the...

 Open Access DOI:10.23937/2469-5831/1510021

A Comparative Study of Three Classification Procedures: Asthma among Healthcare Professionals in Texas

Dejian Lai, Ahmed A Arif, Haiyun Xu and George L Delclos

Article Type: Original Research article | First Published: April 29, 2019

Statistical classification analysis has been widely used in many fields. In this article, we applied and compared three different classification procedures: Logistic regression, Fisher''s linear discriminant function and the second order Bahadur representation to two datasets from two surveys on asthma among healthcare professional in Texas. The first dataset contained 102 subjects and the second dataset 2963. The concordance of the classification from the three statistical procedures with possi...

 Open Access DOI:10.23937/2469-5831/1510020

An Approximation of a Longitudinal Stochastic Model

Khalid A Salah

Article Type: Research Article | First Published: March 25, 2019

We propose to approximate a model for repeated measures that incorporated random effects, correlated stochastic process and measurements error. The stochastic process used in this paper is the Integrated Ornstein-Uhlenbeck (IOU) process. We consider a Bayesian approach which is motivated by the complexity of the model, thus, we propose to approximate the IOU stochastic process into a continuous spatial model that constructed by convolving a very simple and independent, process with a kernel func...

 Open Access DOI:10.23937/2469-5831/1510019

Correlation Statistic for Assessing a Diagnostic Value Based on a Bivariate Bernoulli Distribution with Application to a Retrospective Single-Center Clinical Study

Xiaoyong Wu, Jayesh P Rai, Guohua Yan, Srivastava DK and Shesh N Rai

Article Type: RESEARCH ARTICLE | First Published: March 04, 2019

Assessing the performance of diagnostic tests for repeated binary measurements is very important in clinical trials and diagnostic medicine. The gastric-emptying studies involve 4-hourly measurements of emptying. Empirical results suggest that the gastric emptying results over time are correlated and therefore failure to consider the correlation in statistical measures may not produce satisfactory assessments. If these measurements are highly correlated/associated, early gastric emptying can be ...

 Open Access DOI:10.23937/2469-5831/1510018

Reassessing the Effectiveness of Right Heart Catheterization (RHC) in the Initial Care of Critically Ill Patients using Targeted Maximum Likelihood Estimation

Hai Zhu, Mary Akosile, Shuqin Zhang, Nils P Johnson, Dejian Lai and Hongjian Zhu

Article Type: Research Article | First Published: July 28, 2018

Right heart catheterization (RHC) is a well-established diagnostic tool for patients with congenital and acquired right heart disease and to actively monitor critically ill patients in the intensive care unit. Notably, previous randomized controlled trials and observational studies provide limited support for the clinical utilization of RHC in critically ill patients. However, traditional statistical methods incorporating propensity scores rely heavily on potentially invalid parametric assumptio...

 Open Access DOI:10.23937/2469-5831/1510017

Partial Variable Selection and its Applications in Biostatistics

Jingwen Gu, Ao Yuan, Chunxiao Zhou, Leighton Chan and Ming T Tan

Article Type: Research Article | First Published: April 14, 2018

We propose and study a method for partial covariates selection, which only select the covariates with values fall in their effective ranges. The coefficients estimates based on the resulting data is more interpretable based on the effective covariates. This is in contrast to the existing method of variable selection, in which some variables are selected/deleted in whole. To test the validity of the partial variable selection, we extended the Wilks theorem to handle this case. Simulation studies ...

 Open Access DOI:10.23937/2469-5831/1510016

Improved Wald Test for Equivalence Assessment of Analytical Biosimilarity

Yu-Ting Weng, Yi Tsong, Meiyu Shen and Chao Wang

Article Type: Research Article | First Published: March 15, 2018

The equivalence test in analytical similarity assessment uses a margin of 1.5 times of the standard deviation of a reference product. In the current practice, the standard deviation, estimated from study data, is considered as a fixed constantin the margin....

 Open Access DOI:10.23937/2469-5831/1510015

Analogs of the Wilcoxon-Mann-Whitney Test When There is a Covariate

Rand R Wilcox

Article Type: Research Article | First Published: December 22, 2017

Certainly the best-known method for making inferences about p is the Wilcoxon-Mann-Whitney (WMW) test. It is well known, however, that under general conditions, the WMW method uses an incorrect estimate of the standard error. Numerous methods have been derived for dealing with this issue....

 Open Access DOI:10.23937/2469-5831/1510014

Bayesian Cox Proportional Hazards Model in Survival Analysis of HACE1 Gene with Age at Onset of Alzheimer's Disease

Ke-Sheng Wang, Ying Liu, Shaoqing Gong, Chun Xu, Xin Xie, Liang Wang and Xingguang Luo

Article Type: Research Article | First Published: December 01, 2017

Alzheimer's Disease (AD), the most common form of dementia, is a chronic neurodegenerative disease. The HECT domain and ankyrin repeat containing E3 ubiquitin protein ligase 1 (HACE1) gene is expressed in human brain and may play a role in the pathogenesis of neurodegenerative disorders....

 Open Access DOI:10.23937/2469-5831/1510013

On Sample Size Calculation for Exact Group Sequential Tests for Rare Disease

Man Jin and James L Kepner

Article Type: Research Article | First Published: October 09, 2017

For a rare disease, all the patients having the disease constitute a small population, and the standard single-stage hypergeometric test is uniformly most powerful to evaluate the response probability of a specific treatment regimen....

 Open Access DOI:10.23937/2469-5831/1510012

A Systematic Approach to Increase Reproducibility in Simulation Studies

Xiaoyong Wu and Shesh N Rai

Article Type: Research Article | First Published: October 07, 2017

Reproducibility of results in simulation studies plays a key role in statistical science. Although P-value occupies a prominent place for determining statistical significance in replicate studies, there is always possibility of extra variability across samples leading to irreproducible results. Recently, Halsey, et al....

 Open Access DOI:10.23937/2469-5831/1510011

Can We Identify Patients at High Risk of Harm under a Generally Safe Intervention?

Gerd K Rosenkranz

Article Type: Research Article | First Published: September 23, 2017

Personalized medicine today is primarily addressing efficacy. Here we investigate and illustrate the role that precision medicine could play in drug safety by supporting the identification of subjects at high risk of harm by an otherwise safe and efficacious treatment. Predicting potential harm requires high sensitivity of a classification rule....

 Open Access DOI:10.23937/2469-5831/1510010

Inference Based on Small Randomized Oncology Clinical Trials: Is the Observed Treatment Effect True?

Joyce Cheng, Hui Zhang, Shenghui Tang and Rajeshwari Sridhara

Article Type: Original Article | First Published: May 20, 2017

The drug development paradigm in oncology has changed in recent times as developments in science and technology have led to more targeted therapies. Drug products are receiving marketing approvals based on single randomized studies enrolling 100-200 patients, including early phase (phase II) clinical trials....

 Open Access DOI:10.23937/2469-5831/1510009

Hierarchical Bayes Approach for Analysis of Item-Level Missing Data

Junshan Qiu and Ram Tiwari

Article Type: Research Article | First Published: June 30, 2016

Missing data are primarily due to dropout which can be categorized into different types based on its relation to the response process. For simplicity, it is generally assumed that the relation between a specific type of dropout and the response process can be described using a single (indicator) random variable. In case of distinct types of dropout, it is natural to use the multinomial indicator variables to model the dropout....

 Open Access DOI:10.23937/2469-5831/1510008

A Constrained Non-inferiority Approach for Assessing Clinical Efficacy to Establish Biosimilarity

Jason JZ Liao

Article Type: Research Article | First Published: December 3, 2015

To develop a biosimilar product, it is necessary to demonstrate biosimilarity between the proposed biosimilar product and the reference product in terms of the purity, potency, efficacy, and safety. In this paper, clinical efficacy data required for establishing biosimilarity are considered. Non-inferiority (NI) and equivalence methods are commonly used for analyzing clinical trials to meet this requirement. The equivalence approach often requires large, costly, and lengthy clinical trials....

 Open Access DOI:10.23937/2469-5831/1510007

Target Frequency Analysis of functional MRI Data

Michael A. Frolich, Paul Jung and Shannon Starr

Article Type: Research Article | First Published: November 2, 2015

The field of functional magnetic resonance imaging (fMRI) has grown in usage, applications, and complexity. The results of a general linear model (GLM) analysis vary from one investigator to another as they depend on image preprocessing, model choices and physiological assumptions. There is a need for a simple, efficient and consistent analysis method. Methods: We propose the target frequency analysis (TFA) as an intuitive, computationally efficient method to analyze data from block design fMRI ...

 Open Access DOI:10.23937/2469-5831/1510006

Noise Analysis of Gene Regulatory Networks Using Particle Filter

Haixin Wang and Dawit Aberra

Article Type: Original Article | First Published: October 03, 2015

One of the most important properties in gene expression is the stochasticity. Gene expression process is noisy and fluctuant. In this paper, the noise of gene regulatory networks (GRNs) using polynomial model and S-system model is analyzed by proposed approach on the basis of particle filter. The measurement noise and process noise are analyzed to test noise effects on the synthetic GRNs. The relation among Root Mean Square (RMS) error, measurement noise, and system noise covariance is analyzed....

 Open Access DOI:10.23937/2469-5831/1510005

Training a Nonclinician to Become a Leader in Transdisciplinary Clinical Research: Clinical Observerships

Douglas D Gunzler, James C Spilsbury, Michael Fu, Susannah Rose, Neal V Dawson, Shirley Moore and Thomas E Love

Article Type: Original Article | First Published: September 28, 2015

As institutions and funders expand their efforts toward multi-disciplinary, interdisciplinary, and even transdisciplinary research, there is a substantial need for scientists who can lead such efforts. The traditional image of a leader of transdisciplinary clinical research is a quantitatively savvy clinician conducting research at some point along the continuum from the 'bench to the bedside'. However, this is not the only alternative. Nonclinician scientists can also provide effective leadersh...

 Open Access DOI:10.23937/2469-5831/1510004

Bayesian Survival Analysis of Genetic Variants in PTPRN2 Gene for Age at Onset of Cancer

Ke-Sheng Wang, Yue Pan, Weize Wang and Chun Xu

Article Type: Research Article | First Published: September 9, 2015

The protein tyrosine phosphatase, receptor type, N polypeptide 2 (PTPRN2) gene may play a role in cancer; however, no study has focused on the associations of genetic variants within the PTPRN2 gene with age at onset (AAO) of cancer. Methods: This study examined 220 single nucleotide polymorphisms (SNPs) within the PTPRN2 gene in the Marshfield sample with 716 cancer cases (any diagnosed cancer, excluding minor skin cancer) and 2,848 non-cancer controls. Multiple logistic regression model and li...

 Open Access DOI:10.23937/2469-5831/1510003

A Review of Graphical Approaches to Common Statistical Analyses. The Omnipresence of Latent Variables in Statistics

Emil N. Coman, L. Suzanne Suggs, Maria Coman and Eugen Iordache and Judith Fifield

Article Type: Review Article | First Published: September 4, 2015

We provide a comprehensive review of simple and advanced statistical analyses using an intuitive visual approach explicitly modeling Latent Variables (LV), likely to better illuminate what is assumed in each analytical method and what is actually estimated, by translating the causal relationships embedded in the graphical models in equation form. We recommend the graphical display rooted in the century old path analysis, that details all parameters of each statistical model, and suggest labeling...

 Open Access DOI:10.23937/2469-5831/1510002

Drug Treatment Comparison for Total Knee Replacement Surgery

Kevin Soderholm and Rhonda Magel

Article Type: Research Article | First Published: September 02, 2015

Data from over 2000 patients receiving knee replacement surgery was gathered from a hospital system in the Midwestern United States. The age group that each patient belonged to was noted, under age 65 or 65 years of age and older, as well as their gender. A variety of drugs in each of three drug categories was studied as to their association with total hospital cost, length of stay, prevalence of early readmissions and prevalence of blood transfusions. The drug categories included spinal blocks,...

 Open Access DOI:10.23937/2469-5831/1510001

Dynamic Factor Analysis for Multivariate Time Series: An Application to Cognitive Trajectories

Yorghos Tripodis and Nikolaos Zirogiannis

Article Type: Research Article | First Published: August 28, 2015

We propose a dynamic factor model appropriate for large epidemiological studies and develop an estimation algorithm which can handle datasets with large number of subjects and short temporal information. The algorithm uses a two cycle iterative approach for parameter estimation in such a large dataset. Each iteration consists of two distinct cycles, both following an EM algorithm approach. This iterative process will continue until convergence is achieved. We utilized a dataset from the National...


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ClinMed Journals Index Copernicus Values

Clinical Medical Image Library: 93.51

International Journal of Critical Care and Emergency Medicine: 92.83

International Journal of Sports and Exercise Medicine: 91.84

International Journal of Womens Health and Wellness: 91.79

Journal of Musculoskeletal Disorders and Treatment: 91.73

Journal of Geriatric Medicine and Gerontology: 91.55

Journal of Infectious Diseases and Epidemiology: 91.55

Clinical Medical Reviews and Case Reports: 91.40

International Archives of Nursing and Health Care: 90.87

International Journal of Ophthalmology and Clinical Research: 90.80

International Archives of Urology and Complications: 90.73

Journal of Clinical Nephrology and Renal Care: 90.33

Journal of Family Medicine and Disease Prevention: 89.99

Journal of Clinical Gastroenterology and Treatment: 89.54

Journal of Dermatology Research and Therapy: 89.34

International Journal of Clinical Cardiology: 89.24

International Journal of Radiology and Imaging Technology: 88.88

Obstetrics and Gynaecology Cases - Reviews: 88.42

International Journal of Blood Research and Disorders: 88.22

International Journal of Diabetes and Clinical Research: 87.97

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