A Key Pre-Distribution Scheme Based on µ-PBIBD for Enhancing Resilience in Wireless Sensor Networks.

Many key pre-distribution (KPD) schemes based on combinatorial design were proposed for secure communication of wireless sensor networks (WSNs). Due to complexity of constructing the combinatorial design, it is infeasible to generate key rings using the corresponding combinatorial design in large scale deployment of WSNs. In this paper, we present a definition of new combinatorial design, termed “µ-partially balanced incomplete block design (µ-PBIBD)”, which is a refinement of partially balanced incomplete block design (PBIBD), and then describe a 2-D construction of µ-PBIBD which is mapped to KPD in WSNs. Our approach is of simple construction which provides a strong key connectivity and a poor network resilience. To improve the network resilience of KPD based on 2-D µ-PBIBD, we propose a KPD scheme based on 3-D Ex-µ-PBIBD which is a construction of µ-PBIBD from 2-D space to 3-D space. Ex-µ-PBIBD KPD scheme improves network scalability and resilience while has better key connectivity. Theoretical analysis and comparison with the related schemes show that key pre-distribution scheme based on Ex-µ-PBIBD provides high network resilience and better key scalability, while it achieves a trade-off between network resilience and network connectivity.

The use of fixed study main effects in arm-based network meta-analysis.

Methods of network meta-analysis (NMA) can be classified as arm-based and contrast-based approaches. There are several arm-based approaches, and some of these have been criticized because they recover inter-study information and hence do not obey the principle of concurrent control. Here, we point out that recovery of inter-study information in arm-based NMA can be prevented by fitting a fixed main effect for studies. Advantages of arm-based NMA are discussed.

Innovative Design and Analysis for PK/PD Biosimilar Bridging Studies with Multiple References.

When there are multiple reference products, (e.g., EU-approved product and US-licensed product), a pharmacokinetic/pharmacodynamic (PK/PD) bridging study is often conducted in order to bridge the clinical data from the original region (e.g., Europe) to the new region (e.g., USA) in support of the biosimilar regulatory submission in the new region. The purpose is to avoid duplicated clinical trials for clinical similarity between a proposed biosimilar product and the reference product in the new region provided that there is no ethnic concern in the two regions. In this article, some innovative statistical designs for PK/PD biosimilar bridging studies are proposed. Statistical model and methods under the proposed statistical designs are studied. Power analysis for sample size requirement based on Schuirmann's two one-sided tests procedure is also derived and compared to pairwise testing using simulation.

Efficient baseline utilization for incomplete block crossover clinical trials.

Incomplete block crossover trials with period-specific baseline and post-baseline (outcome) measures for each subject are often used in clinical drug development; without loss of generality, we focus on the three-treatment two-period ( 3×2 ) crossover. Data from such trials are commonly analyzed using a mixed effects model with indicator terms for treatment and period, and an unstructured covariance matrix for the vector of intra-subject measurements. It is well-known that treatment effect estimates from this analysis are complex functions of both within-subject and between-subject treatment contrasts. We caution that the associated type I error rate and power for hypothesis testing can be non-trivially influenced by how the baselines are utilized. Specifically, the mixed effects analysis which uses change from baseline as the dependent variable is shown to consistently underperform corresponding analyses in which the outcome is the dependent variable and linear combinations of the baselines are used as period-specific and/or period-invariant covariates. A simpler fixed effects analysis of covariance involving only within-subject contrasts is also described for small sample situations in which the mixed effects analyses can suffer from increased type I error rates. Theoretical insights, simulation results and an illustrative example with real data are used to develop the main points.

Improving the Assessment of Differential Item Functioning in Large-Scale Programs With Dual-Scale Purification of Rasch Models: The PISA Example.

By design, large-scale educational testing programs often have a large proportion of missing data. Since the effect of missing data on differential item functioning (DIF) assessment has been investigated in recent years and it has been found that Type I error rates tend to be inflated, it is of great importance to adapt existing DIF assessment methods to the inflation. The DIF-free-then-DIF (DFTD) strategy, which originally involved one single-scale purification procedure to identify DIF-free items, has been extended to involve another scale purification procedure for the DIF assessment in this study, and this new method is called the dual-scale purification (DSP) procedure. The performance of the DSP procedure in assessing DIF in large-scale programs, such as Program for International Student Assessment (PISA), was compared with the DFTD strategy through a series of simulation studies. Results showed the superiority of the DSP procedure over the DFTD strategy when tests consisted of many DIF items and when data were missing by design as in large-scale programs. Moreover, an empirical study of the PISA 2009 Taiwan sample was provided to show the implications of the DSP procedure. The applications as well as further studies of DSP procedure are also discussed.