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Self-Controlled Case Series Studies
Self-Controlled Case Series Studies: A Modelling Guide with R provides the first comprehensive account of the self-controlled case series (SCCS) method, a statistical technique for investigating associations between outcome events and time-varying exposures. The method only requires information from individuals who have experienced the event of interest, and automatically controls for multiplicative time-invariant confounders, even when these are unmeasured or unknown. It is increasingly being used in epidemiology, most frequently to study the safety of vaccines and pharmaceutical drugs. Key features of the book include: A thorough yet accessible description of the SCCS method, with mathemat...
Self-Controlled Case Series Methodology
The self-controlled case series method is an epidemiological study design in which individuals act as their own control. The method offers advantages but has several limitations. This article outlines the self-controlled case series method and reviews methodological developments that address some of these limitations.
Comparison of Birth Weight Centile Calculators, Intergrowth, WHO, Modified WHO and GROW
BackgroundPrediction of small for gestational age (SGA) or large for gestational age (LGA) is vital in reducing adverse pregnancy outcomes. Accurate SGA and LGA classification method is needed in developing a good prediction model.AimsThe aim of the study was to make comparison among four methods used in determining birth weight centiles. The methods are Intergrowth, WHO-UK, modified WHO-UK and GROW. We also want to compare how fasting and 2hr glucose levels at 24-28 weeks of gestation affect birth weight centiles when implementing the four methods.MethodMaternity data from a cohort of 4743 pregnancies in the UK were analysed. The four methods were used to classify the births weights as smal...
Lower Adiponectin Response During OGTT in Pregnancy is Associated with Higher Maternal BMI and Gestational Diabetes
BackgroundBMI is negatively associated with adiponectin (ADP) levels. In pregnancy, first trimester ADP levels are associated with gestational diabetes mellitus (GDM) and cardiovascular risk after GDM pregnancy1 2. However, it is not known whether ADP levels dynamically change during oral glucose tolerance test (OGTT) and whether this is associated with insulin levels. Our aim was to study the adiponectin (ADP) profile during OGTT at GDM diagnosis and its relationship with glucose and insulin levels.tMethodsA prospective study of selectively screened women was conducted (n=57). Maternal anthropometry and lipid profile were measured in the first trimester. Serum ADP, insulin and glucose were ...
Medical Product Safety Evaluation
Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in t...
Mathematical and Statistical Skills in the Biopharmaceutical Industry
Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors’ experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusse...
Platform Trial Designs in Drug Development
Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as...
Analysis of Incidence Rates
Incidence rates are counts divided by person-time; mortality rates are a well-known example. Analysis of Incidence Rates offers a detailed discussion of the practical aspects of analyzing incidence rates. Important pitfalls and areas of controversy are discussed. The text is aimed at graduate students, researchers, and analysts in the disciplines of epidemiology, biostatistics, social sciences, economics, and psychology. Features: Compares and contrasts incidence rates with risks, odds, and hazards. Shows stratified methods, including standardization, inverse-variance weighting, and Mantel-Haenszel methods Describes Poisson regression methods for adjusted rate ratios and rate differences. Ex...
Innovative Methods for Rare Disease Drug Development
In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this case, innovative approaches are needed for providing substantial evidence meeting the same standards for statistical assurance as drugs used to treat common conditions. Innovative Methods for Rare Disease Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical research and...
