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.
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).
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.
- 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
A brief demonstration of PVClinical project
PVClinical in detail
Full Title:PVClinical – Active Pharmacovigilance in Clinical Environments
Funding Organization:Operational Program Competitiveness, Entrepreneurship and Innovation, under the call «RESEARCH – CREATE - INNOVATE»
Start – End Date
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)
Pantelis NatsiavasPVClinical Coordinator & Software Engineer/Researcher INAB|CERTH, replacing late Vassilis Koutkias
Vlasios DimitriadisSoftware Engineer INAB|CERTH
Stella DimitsakiSoftware Engineer INAB|CERTH
Christine KakalouSoftware Engineer INAB|CERTH
Achilleas ChytasSoftware Engineer INAB|CERTH
Panagiotis BonotisSoftware Engineer INAB|CERTH
Ioanna KoukliManaging Director Pharmassist Ltd
Georgia KolangiPharmacovigilance Manager
Dafni KariotiSenior Drug Safety Officer Pharmassist Ltd
Zacharoula LinardakiDrug Safety Officer Pharmassist Ltd
Konstantinos StavrinosMedical Affairs Manager Pharmassist Ltd,
Sotiris KrontirisIT Manager Pharmassist Ltd,
Engineer of Applied Computing and Multimedia
PAPAGEORGIOU GENERAL HOSPITAL
Stella DoumaDirector of the 3rd Clinical Pathology Clinic PGH,
Pathology Professor AUTH
Maria K. BigakiProject Manager PGH
Eugenia Gkaliagkousi3rd Clinical Pathology Clinic PGH,
Pathology Assistant Professor AUTH
Antonios LazaridisClinical Pathology Resident PGH
EUROPEAN INTERBALKAN MEDICAL CENTRE
Chrysanthos ZampoulisDirector of the Clinical Pathology Clinic
of European Interbalkan Medical Centre,
Pathology Professor AUTH
Konstantinos KargiotisInternist European Interbalkan Medical Centre
- Scientific Publications
- “Identifying Actionability as a Key Factor for the Adoption of ‘Intelligent’ Systems for Drug Safety: Lessons Learned from a User-Centred Design Approach”, Drug Saf., vol. 44, no. 11, 2021, https://doi.org/10.1007/s40264-021-01103-w ,
- “Pharmacovigilance and Clinical Environment: Utilizing OMOP-CDM and OHDSI Software Stack to Integrate EHR Data”, Studies in Health Technology and Informatics, IOS Press, Vol. 281, pp. 555–559, https://doi.org/10.3233/SHTI210232 ,
- “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 ,
- “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. ,
- “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 ,
Project Identity Logo
Project's Official Poster
A PVClinical Overview
Article in "Life Duty" magazine published by partner PGH (Issue 45, Page 9, in Greek)
Article title: "A Drug Safety Web Platform "
Participation at Medical Informatics Europe 2022 conference; Pantelis Natsiavas and Achilles Chytas presenting «PVClinical platform demo: An open source web platform enabling multi-modal Active Pharmacovigilance».
«Novel approaches for the enhancement of Drug Safety, by the Institute of Applied Biosciences at CERTH», an interview given by Dr. Pantelis Natsiavas.
Participation at Medical Informatics Europe 2021 conference, presenting «Pharmacovigilance and clinical environment - Utilizing OMOP-CDM and OHDSI software stack to integrate EHR data».
Presentation of PVClinical, by Mr. Pantelis Natsiavas, in the Hellenic Society of Pharmaceutical Medicine (EL.E.F.I.) annual scientific event titled: «New technology and challenges in Pharmacovigilance for 2020».
Presentation of PVClinical user requirements and design aspects at MedInfo2019, on August 29, 2019, Lyon, France (https://doi.org/10.3233/SHTI190376).
Presentation of PVClinical by Mr. Pantelis Natsiavas in the 4th Hellenic Society of Pharmaceutical Medicine (EL.E.F.I.) Congress.
Lecture on computational advances in drug safety / pharmacovigilance enabled by Knowledge Engineering by Mr. Pantelis Natsiavas, at LIMICS, Paris, France.
Scientific study funded by PVClinical accepted for publication in Frontiers in Pharmacology (https://doi.org/10.3389/fphar.2019.00415).
Scientific paper on the design of the PVClinical platform accepted for presentation at MedInfo 2019, August 26-30, 2019, Lyon, France.
INAB|CERTH researchers visit PHARMA (3rd December, 2018), EIMC (20th January, 2019) and GHP (31st January, 2019) regarding Deliverable 1.1 (Requirements Analysis).
Poster presentation of the project in the international conference SWAT4HCLS (Semantic Web Applications and Tools for Healthcare and Life Sciences), December 3-6, 2018, Antwerp, Belgium.
PVClinical kick-off meeting held in INAB|CERTH premises, Thermi, Thessaloniki, on November 7, 2018, with the presence of all project partners.
PVClinical Coordinator & Software Engineer/Researcher,
Institute of Applied Biosciences (INAB),
Centre for Research & Technology Hellas (CERTH)
Address:6th Km. Charilaou-Thermi Road,
P.O. Box 60631, GR 57001, GREECE