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...
