Related papers: Semantic Similarity-Informed Bayesian Borrowing fo…
We present a graphical, knowledge-based method for reviewing treatment-emergent adverse events (AEs) in clinical trials. The approach enhances MedDRA by adding a hidden medical knowledge layer (Safeterm) that captures semantic relationships…
Spontaneous reporting system databases are key resources for post-marketing surveillance, providing real-world evidence (RWE) on the adverse events (AEs) of regulated drugs or other medical products. Various statistical methods have been…
Large sample behavior of dynamic information borrowing (DIB) estimators is investigated. Asymptotic properties of several DIB approaches (adaptive risk minimization, adaptive LASSO, Bayesian procedures with empirical power prior, fully…
There is currently a focus on statistical methods which can use external trial information to help accelerate the discovery, development and delivery of medicine. Bayesian methods facilitate borrowing which is "dynamic" in the sense that…
For dynamic borrowing to leverage external data to augment the control arm of small RCTs, the key step is determining the amount of borrowing based on the similarity of the outcomes in the controls from the trial and the external data…
We introduce a Bayesian nonparametric inference approach for aggregate adverse event (AE) monitoring across studies. The proposed model seamlessly integrates external data from historical trials to define a relevant background rate and…
Bayesian dynamic borrowing (BDB) and synthetic control methods (SCM) are both used in clinical trial design when recruitment, retention, or allocation is a challenge. The performance of these approaches has not previously been directly…
Inferring adverse events (AEs) of medical products from Spontaneous Reporting Systems (SRS) databases is a core challenge in contemporary pharmacovigilance. Bayesian methods for pharmacovigilance are attractive for their rigorous ability to…
Objective: The objective of this study is to develop a deep learning pipeline to detect signals on dietary supplement-related adverse events (DS AEs) from Twitter. Material and Methods: We obtained 247,807 tweets ranging from 2012 to 2018…
Optimally sequencing experimental assays in drug discovery is a high-stakes planning problem under severe uncertainty and resource constraints. A primary obstacle for standard reinforcement learning (RL) is the absence of an explicit…
Symmetric positive definite (SPD) matrices are useful for capturing second-order statistics of visual data. To compare two SPD matrices, several measures are available, such as the affine-invariant Riemannian metric, Jeffreys divergence,…
Basket trials have emerged as a new class of efficient approaches in oncology to evaluate a new treatment in several patient subgroups simultaneously. In this paper, we extend the key ideas to disease areas outside of oncology, developing a…
We present SHIELD, a novel methodology for automated and integrated safety signal detection in clinical trials. SHIELD combines disproportionality analysis with semantic clustering of adverse event (AE) terms applied to MedDRA term…
The objective of our work is to demonstrate the feasibility of utilizing deep learning models to extract safety signals related to the use of dietary supplements (DS) in clinical text. Two tasks were performed in this study. For the named…
Evidence accumulation models (EAMs) are an important class of cognitive models used to analyze both response time and response choice data recorded from decision-making tasks. Developments in estimation procedures have helped EAMs become…
Bayesian dynamic borrowing has become an increasingly important tool for evaluating the consistency of regional treatment effects which is a key requirement for local regulatory approval of a new drug. It helps increase the precision of…
Meta-analysis is a powerful tool for assessing drug safety by combining treatment-related toxicological findings across multiple studies, as clinical trials are typically underpowered for detecting adverse drug effects. However, incomplete…
Anomaly detection in database management systems (DBMSs) is difficult because of increasing number of statistics (stat) and event metrics in big data system. In this paper, I propose an automatic DBMS diagnosis system that detects anomaly…
Multi-label classification (MLC) of medical images aims to identify multiple diseases and holds significant clinical potential. A critical step is to learn class-specific features for accurate diagnosis and improved interpretability…
Building Management Systems (BMS) are crucial in the drive towards smart sustainable cities. This is due to the fact that they have been effective in significantly reducing the energy consumption of buildings. A typical BMS is composed of…