Detection of drug safety signals from clinical trials data

Detection of drug safety signals from clinical trials data - PubMed

One of the main goals of safety management in clinical trials is to detect suspected unexpected serious adverse reactions (SUSARs).

Detection of drug safety signals from clinical trials data: Role of ...

This study indicates that one quarter of SUSARs collected in academic clinical trials refers to potential safety signals, especially for oncologic drugs.

Detection of drug safety signals from clinical trials data

This study demonstrates that SUSARs from academic studies could be used as a source of safety signals for marketed drugs.

Methods for drug safety signal detection using routinely collected ...

Signal detection is a crucial step in the discovery of post‐marketing adverse drug reactions. There is a growing interest in using routinely collected data ...

EVIDEX® Signal Detection - TriNetX

These data are stored in a database that is either hosted and maintained by the company itself, or outsourced to a technology or full services contract research ...

Potential Signals of Serious Risks/New Safety Information Identified ...

When a potential signal of a serious risk is identified from FAERS data, it is entered as a safety issue into CDER's Document Archiving, ...

A New Drug Safety Signal Detection and Triage System Integrating ...

Signal detection concerned the application of data-mining tools to identify potential safety signals of the drug of interest, while signal ...

Detection of drug safety signals from clinical trials data - ResearchGate

Abstract. One of the main goals of safety management in clinical trials is to detect suspected unexpected serious adverse reactions (SUSARs).

Signal detection statistics of adverse drug events in hierarchical ...

It is particularly beneficial when dealing with hierarchical data structures. One may use a retrospective case–control study design from ...

Practical Aspects of Signal Detection in Pharmacovigilance

Prin- ciples and practical recommendations for signal detection with clinical trial data have ... safety data from clinical trials. If the product becomes ...

Drug safety assessment in clinical trials: methodological challenges ...

Data from spontaneous reporting systems may be of particular interest for detecting signals for rare, unusual adverse events, such as the ...

Chapter 11: Signal detection methodology and application - ENCePP

Quantitative analysis of spontaneous adverse drug reaction reports is routinely used in drug safety research. Several articles have been published on ...

An MCEM Framework for Drug Safety Signal Detection and ... - Nature

Due to the valuable information SRS data can provide, mining drug safety signals from SRS has become a highly active research area. During the ...

Important Considerations for Signal Detection and Evaluation

Perez C, Olivier P, Lortal B, et al. Detection of drug safety signals from clinical trials data: role of SUSARs. Pharmacol Res. 2018;131:218–23.

Safety signal | European Medicines Agency (EMA)

Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under ...

The Use of Social Media in Detecting Drug Safety–Related New ...

In addition, social media can be monitored in real time, and adverse events caused by off-label use, unknown in clinical trials, can be detected ...

Practical applications of regulatory requirements for signal detection ...

The ultimate goal of safety signal detection in clinical trials is to translate clinically significant safety information to the product label ...

Characterization and corroboration of safety signals identified from ...

6 From these quarterly reports, we identified all potential safety signals, including the drug name, adverse events for the signal, and FDA ...

Machine Learning for Detection of Safety Signals From ... - Frontiers

Labeled data is comprised of gold standard data and unknown ADR data. The gold standard represents if each AE associated with a drug from SRS ...

Detection of drug safety signals from clinical trials data - CoLab

This study indicates that one quarter of SUSARs collected in academic clinical trials refers to potential safety signals, especially for ...