Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

Download

10.1155:2015:976272.pdf

Date

2015

Author

Sinaci, A. Anil
Laleci Erturkmen, Gokce B.
Gonul, Suat
Yuksel, Mustafa
Invernizzi, Paolo
Thakrar, Bharat
Pacaci, Anil
Cinar, H. Alper
Çiçekli, Fehime Nihan

Metadata

Show full item record

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Item Usage Stats

174
views

115
downloads

Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases.

URI

https://hdl.handle.net/11511/51182

Journal

BioMed Research International

DOI

https://doi.org/10.1155/2015/976272

Collections

Department of Computer Engineering, Article

Suggestions

OpenMETU
Core

Semantic transformation framework to enable statistical research on medical summaries Paçacı, Anıl; Altıngövde, İsmail Sengör; Doğaç, Asuman; Department of Computer Engineering (2015) One of the important aspects of the clinical research studies carried out in the pharmacovigilance and pharmacoepidemiology is the postmarketing drug surveillance. Utilization of the available Electronic Health Record (EHR) data is key to complement and strengthen the postmarketing safety studies. In addition, EHRs provide a huge, but still under-utilized source of information for the observational studies in clinical research. However, use of different EHR data models and vocabularies presents an important...
Peptide-based diagnostic and therapeutic agents: Where we are and where we are heading? PARLAK KHALİLY, MELEK; Soydan, Medine (2022-11-01) Peptides are increasingly present in all branches of medicine as innovative drugs, imaging agents, theragnostic, and constituent moieties of other sophisticated drugs such as peptide-drug conjugates. Due to new developments in chemical synthesis strategies, computational biology, recombinant technology, and chemical biology, peptide drug development has made a great progress in the last decade. Numerous natural peptides and peptide mimics have been obtained and studied, covering multiple therapeutic areas. ...
Nanoparticles Based on Plasma Proteins for Drug Delivery Applications Tezcaner, Ayşen; Keskin, Dilek (2016-01-01) Background: Nanoparticulate delivery systems receive a lot of attention in pharmaceutical research and market due to their in vivo stability, ability to protect entrapped drug, and ease of cellular penetration. The hemo-compatibility and the clearance half-life are important parameters of the nanodelivery systems that will be administered through intravenous route. Natural components, like blood plasma proteins are ideal sources of biomaterial for such systems with their long in vivo half-lives. Methods: Th...
DEEPScreen: high performance drug-target interaction prediction with convolutional neural networks using 2-D structural compound representations Rifaioğlu, Ahmet Süreyya; Nalbat, Esra; Atalay, Mehmet Volkan (2020-03-07) The identification of physical interactions between drug candidate compounds and target biomolecules is an important process in drug discovery. Since conventional screening procedures are expensive and time consuming, computational approaches are employed to provide aid by automatically predicting novel drug-target interactions (DTIs). In this study, we propose a large-scale DTI prediction system, DEEPScreen, for early stage drug discovery, using deep convolutional neural networks. One of the main advantage...
Surface functionalization of SBA - 15 particles for amoxicillin delivery Sevimli, Filiz F; Yılmaz, Ayşen; Department of Chemistry (2011) There are several studies in order to control drug delivery, decrease the toxicity of drugs and also for novel biomedical applications. It is necessary to be able to control the release of the drug within the body by using drug delivery systems. Mesoporous silica compounds have only been discovered twenty years ago and they have already attracted many researchers to study these materials for several applications. SBA-15 particles have a highly ordered regular structure and are a good matrix for guest-host a...

Citation Formats

A. A. Sinaci et al., “Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies,” BioMed Research International, pp. 1–10, 2015, Accessed: 00, 2020. [Online]. Available: https://hdl.handle.net/11511/51182.