Related papers: Test-Negative Designs with Multiple Testing Source…

The usual problem for group testing is this: For a given number of individuals and a given prevalence, how many tests T* are required to find every infected individual? In real life, however, the problem is usually different: For a given…

Statistical methods are developed for analysis of clinical and virus genetics data from phase 3 randomized, placebo-controlled trials of vaccines against novel coronavirus COVID-19. Vaccine efficacy (VE) of a vaccine to prevent COVID-19…

Count data and recurrent events in clinical trials, such as the number of lesions in magnetic resonance imaging in multiple sclerosis, the number of relapses in multiple sclerosis, the number of hospitalizations in heart failure, and the…

[Background] Recent investigations into the effects of Test-Driven Development (TDD) have been contradictory and inconclusive. This hinders development teams to use research results as the basis for deciding whether and how to apply TDD.…

Cluster-randomized trials are often conducted to assess vaccine effects. Defining estimands of interest before conducting a trial is integral to the alignment between a study's objectives and the data to be collected and analyzed. This…

During the SARS-CoV-2 pandemic, polymerase chain reaction (PCR) and lateral flow device (LFD) tests were frequently deployed to detect the presence of SARS-CoV-2. Many of these tests were singleplex, and only tested for the presence of a…

The COVID-19 pandemic due to the novel coronavirus SARS CoV-2 has inspired remarkable breakthroughs in development of vaccines against the virus and the launch of several phase 3 vaccine trials in Summer 2020 to evaluate vaccine efficacy…

In a tie-breaker design (TBD), subjects with high values of a running variable are given some (usually desirable) treatment, subjects with low values are not, and subjects in the middle are randomized. TBDs are intermediate between…

Pathogens usually exist in heterogeneous variants, like subtypes and strains. Quantifying treatment effects on the different variants is important for guiding prevention policies and treatment development. Here we ground analyses of…

We develop a statistical model for the testing of disease prevalence in a population. The model assumes a binary test result, positive or negative, but allows for biases in sample selection and both type I (false positive) and type II…

The rapid development of COVID-19 vaccines has showcased the global communitys ability to combat infectious diseases. However, the need for post-licensure surveillance systems has grown due to the limited window for safety data collection…

Tie-breaker experimental designs are hybrids of Randomized Controlled Trials (RCTs) and Regression Discontinuity Designs (RDDs) in which subjects with moderate scores are placed in an RCT while subjects with extreme scores are…

We develop semiparametric methods for estimating subgroup-specific relative vaccine efficacy against multiple viral strains in a partially vaccinated population. Focusing on observational case-only studies, we address informative…

Due to the rapidly evolving COVID-19 pandemic caused by the SARS-CoV-2 virus, quick public health investigations of the relationships between behaviours and infection risk are essential. Recently the test-negative design was proposed to…

Regression discontinuity design (RDD) is a quasi-experimental approach to study the causal effects of an intervention/treatment on later health outcomes. It exploits a continuously measured assignment variable with a clearly defined cut-off…

We review vaccine efficacy (VE) estimands for susceptibility in individual randomized trials with natural (unmeasured) exposure, where individual responses are measured as time from vaccination until an event (e.g., disease from the…

Test-driven development (TDD) is a programming technique in which the tests are written prior to the source code. It is proposed that TDD is one of the most fundamental practices enabling the development of software in an agile and…

Connecting the different scales of epidemic dynamics, from individuals to communities to nations, remains one of the main challenges of disease modeling. Here, we revisit one of the largest public health efforts deployed against a localized…

Two observational methods are currently being used to monitor post-deployment vaccine effectiveness: the obvious crude method comparing rate testing positive per head of vaccinated population with that rate per head of unvaccinated…

Based on recent studies, some COVID-19 symptoms can persist for months after infection, leading to what is termed long COVID. Factors such as vaccination timing, patient characteristics, and symptoms during the acute phase of infection may…