• Background

    It is widely accepted that Adverse Drug Reactions (ADRs) have a significant impact on public health, both regarding financial and population health consequences. In Europe it is estimated that 5% of hospitalizations and 179,000 deaths are due to ADRs, while in the United States, studies classify ADRs as the 4th-6th most common cause of death, with 100,000 deaths per year reported in hospitals. Despite their high impact, it should be noted that a big percentage of ADRs is preventable. Consequently, the need for tools that can help timely ADR detection is obvious.

    Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. A PV signal is defined as “information on a new or known adverse event that may be caused by a medicine and requires further investigation”. To date, the identification and confirmation of ADR signals is carried out by PV experts without the use of specialized IT systems, typically through the use of several standalone tools. In this process, experts collect data (mainly from scientific literature, clinical trial databases, and reporting systems) and implement several approaches to assess a potential ADR signal.

    Objectives

    PVClinical aims to develop an advanced computational platform to facilitate and automate the implementation of PV procedures, with particular emphasis on exploring potential ADR signals and focusing on integrating such processes into the clinical environment. Nevertheless, the PVClinical platform is not limited to the clinical environment, as it can be exploited by Contract Research Organizations (CRO) and the pharma industry studying drug safety issues, as well as drug monitoring organizations and regulatory authorities such as the Greek National Medicines Agency (EOF), or the European Medicines Agency (EMA).

    Approach

    Taking into account the relatively low number of Individual Case Safety Reports collected in Spontaneous Reporting Systems (SRSs) and, hence, lack of sufficient data to assess potential ADR signals, the PVClinical platform will gather data from multiple data sources, both conventional (such as SRSs and bibliographic databases) and emerging (e.g. Electronic Health Records, Social Media) in the domain of PV. In particular, a key element of the proposed approach is the integration of large-scale heterogeneous information sources applying the “big data” paradigm, which have so far been used fragmentarily or not used at all, to develop a unified data model to support PV procedures with advanced IT tools.

    Project Structure
    Work Packages

    • WP1: User Requirements Analysis, Specifications and System Architecture
    • WP2: Design and Development of Data Collection Infrastructure
    • WP3: Design and Development of Data Analysis Methods
    • WP4: Implementation of the Web Platform
    • WP5: Evaluation and Pilot Applications
    • WP6: Feasibility Study on Commercial Applicability
    • WP7: SME participation in Exhibitions

    Project Identity

    Abbreviation:

    PVClinical

    Full Title:

    PVClinical – Active Pharmacovigilance in Clinical Environments

    Funding Organization:

    Operational Program Competitiveness, Entrepreneurship and Innovation, under the call «RESEARCH – CREATE - INNOVATE»

    T1EDK-0789

    Project Code

    36 Months

    Duration

    917,200.00

    Total Budget

    06/09/2018 – 05/09/2021

    Start – End Date

    Partners

    Research Teams

    The teams implementing the project consist of experienced and highly trained scientific and technical personnel in the fields of medicine, pharmacy, pharmacovigilance and eHealth technologies.

    Institute of Applied Biosciences, Centre for Research and Technology Hellas
    (ΙΝΑΒ | CERTH)

    Vassilis Koutkias Photo

    Vassilis Koutkias,

    Principal Researcher, PVClinical Coordinator INAB|CERTH
    Pantelis Natsiavas Photo

    Pantelis Natsiavas

    Technical Coordinator, Software Engineer INAB|CERTH
    Vlasios Dimitriadis Photo

    Vlasios Dimitriadis

    Software Engineer INAB|CERTH
    George Gavriilidis Photo

    George Gavriilidis

    Pharmacologist, Research Associate INAB|CERTH
    Vaggelis Gakis Photo

    Vaggelis Gakis

    Software Engineer INAB|CERTH

    PHARMASSIST LTD

    Ioanna Koukli Photo

    Ioanna Koukli

    Managing Director Pharmassist Ltd
    Georgia Kolangi Photo

    Georgia Kolangi

    Pharmacovigilance Manager
    Pharmassist Ltd
    Dafni Karioti Photo

    Dafni Karioti

    Senior Drug Safety Officer Pharmassist Ltd
    Biochemist –Biotechnologist
    Zacharoula Linardaki Photo

    Zacharoula Linardaki

    Drug Safety Officer Pharmassist Ltd
    Konstantinos Stavrinos Photo

    Konstantinos Stavrinos

    Medical Affairs Manager Pharmassist Ltd,
    M.D., Internist
    Sotiris Krontiris Photo

    Sotiris Krontiris

    IT Manager Pharmassist Ltd,
    Engineer of Applied Computing and Multimedia

    PAPAGEORGIOU GENERAL HOSPITAL

    Stella Douma Photo

    Stella Douma

    Director of the 3rd Clinical Pathology Clinic PGH,
    Pathology Professor AUTH
    Maria Bigaki Photo

    Maria K. Bigaki

    Project Manager PGH
    Eugenia Gkaliagkousi Photo

    Eugenia Gkaliagkousi

    3rd Clinical Pathology Clinic PGH,
    Pathology Assistant Professor AUTH
    Antonios Lazaridis Photo

    Antonios Lazaridis

    Clinical Pathology Resident PGH

    EUROPEAN INTERBALKAN MEDICAL CENTRE

    Chrysanthos Zampoulis Photo

    Chrysanthos Zampoulis

    Director of the Clinical Pathology Clinic
    of European Interbalkan Medical Centre,
    Pathology Professor AUTH
    Konstantinos Kargiotis Photo

    Konstantinos Kargiotis

    Internist European Interbalkan Medical Centre

    Results

    • All
    • Deliverables
    • Scientific Publications
    1. P. Natsiavas, A. Malousi, C. Bousquet, M.-C. Jaulent and V. Koutkias, “Computational Advances in Drug Safety: Systematic and Mapping Review of Knowledge Engineering based Approaches”, Frontiers in Pharmacology, 2019, https://doi.org/10.3389/fphar.2019.00415
    2. P. Natsiavas, M.-C. Jaulent and V. Koutkias, “Α Knowledge-based Platform for Assessing Potential Adverse Drug Reactions at the Point of Care: User Requirements and Main Information Processing Workflow Design”, Studies in Health Technology and Informatics, IOS Press, Vol. 264, pp. 1007-1011, https://doi.org/10.3233/SHTI190376.
    3. P. Natsiavas, M.-C. Jaulent and V. Koutkias, “Leveraging Semantic Technologies to Bring Active Pharmacovigilance at the Point of Care”, 11th Int. Conf. on Semantic Web Applications and Tools for Health Care and Life Sciences (SWAT4HCLS), Antwerp, Belgium, December 3-6, 2018, https://figshare.com/articles/Leveraging_Semantic_Technologies_to_Bring_Active_Pharmacovigilance_at_the_Point_of_Care/7325003
    Deliverables Table Image

    Deliverables Table

    PVClinical Deliverables

    Dissemination Material

    Project Logotype

    Project Identity Logo

    Λογότυπο Έργου

    Project Poster

    Project's Official Poster

    Project's Poster

    Project Presentation

    A PVClinical Overview

    Project Presentation

    Article in "Life Duty" magazine published by partner PGH (Issue 45, Page 9, in Greek)

    Article title: "A Drug Safety Web Platform "

    PGH magazine article on PVClinical - Issue 45 Photo

    News

    Contact

    Vassilis Koutkias, Principal Researcher,
    PVClinical Coordinator,
    Institute of Applied Biosciences (INAB),
    Centre for Research & Technology Hellas (CERTH)

    Address:

    6th Km. Charilaou-Thermi Road,
    Thermi, Thessaloniki
    P.O. Box 60631, GR 57001, GREECE