Horizon Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem

Project leader: Dr. Luca Pani

Project collaborators: Dr. Olgica Đurković-Đaković, Dr. Ivana Klun

Project number: 101034366

Duration of the project: January 2022-December 2025.

Leading institution: Università degli Studi di Modena e Reggio Emilia (UNIMORE), Italy

Description of the project:

FACILITATE is a project built on a patient-centred, data-driven, technological platform where dynamic consent allows the returning of clinical trial data to study participants within a GDPR compliant and approved ethical framework. FACILITATE starts off by providing clear rules in a trusted ethical, legal and regulatory ecosystem before engaging patients as data generators. This avoids the current situation where clinical data are siloed in separate repositories without any possibility to be used beyond their original single-sided purpose. FACILITATE will provide the technological solutions to comply with GDPR in medical research by building on the empowered stakeholders’ willingness to share and re-use their data. The FACILITATE Consortium was constituted by drawing from a broad range of capacities to tackle the ambitious challenges related to future clinical trials, such as preventive, long-term and real-world evidence trials. The Consortium takes an innovative approach to data return to study participants by asking them what they need to be implemented to feel in a trusted ecosystem. This requires all Consortium participants to leverage their existing networks to bring together stakeholders at all levels in the decision-making chain, including patients, healthcare professionals, software designers, clinical trials repositories processors and controllers, ethicists, lawyers and other active regulators. Having obtained dynamic consent on the data portability, FACILITATE will re-use and cross-reference them with those contained in other repositories including RWE data captured across multiple settings and devices. FACILITATE will last 4 years and will participate in the extended Pilot on Research Data of Horizon 2020. Its strategy represents a unique and innovative opportunity for medicines drug development and regulation to better understand the clinics of diseases, and to evaluate the effectiveness of products in the healthcare system.

Тип пројекта:

International Projects

Relationship Between Seroprevalence in Major Livestock Species and the Presence of Toxoplasma gondii in Meat

Project leader: Dr. Joke van der Giessen

Project collaborators: Dr. Olgica Djurković-Djaković, Dr. Ivana Klun, Dr. Aleksandra Nikolić, Dr. Branko Bobić, Dr. Aleksandra Uzelac, Dr. Irena Rajnpreht

Project number: GP/EFSA/BIOHAZ/2013/01

Duration of the project: November 2013-November 2015.

Leading institution: National Institute for Public Health and the Environment (RIVM), The Netherlands

Description of the project:

The overall goal of project was to gain information and knowledge on the presence (and viability) of T. gondii cysts in meat and other edible tissues in main meat‐producing animals, and its relationship with T. gondii seroprevalence in animals by carrying out an extensive literature search and review of available data on the subject, as well as performing experimental studies on T. gondii in meat‐producing livestock species in the EU in order to assess the relationship between indirect detection methods (antibody detection), and direct detection methods of infective cysts in meat and other edible tissues (by bio‐assay).

Тип пројекта:

International Projects

Goat–Parasite Interactions: From Knowledge to Control

Project leader: Dr. Smaragda Sotiraki

Project collaborators: Dr. Olgica Đurković-Đaković (member of the management committee of the action), Dr. Ivana Klun, Dr. Tijana Štajner, Dr. Vitomir Djokić

Project number: FA0805

Duration of the project: April 2009-January 2014.

Leading institution: NAGREF Veterinary Research Institute, NAGREF Campus, Thermi 57001, Thessaloniki, Greece

Description of the project:

The main objective of the Action was to advance our knowledge on various aspects of goats’ parasitology and health management towards a better understanding of the different components explaining the specificities of goat-parasite interactions as well as to develop sustainable strategies to control parasitic diseases in goats.

Тип пројекта:

Cost

Epidemiological Risk Models for Vector-Borne Diseases in a Changing World: The Case Study of Mosquito- and Tick-Borne Diseases under Different Conditions of Habitat Integrity, Environment, and Climate

Project leaders: Prof. Duško Ćirović and Dr. Paolo Tizzani

Project collaborators: Dr. Snežana Tomanović, Dr. Darko Mihaljica

Project number:

Duration of the project: 2013-2015.

Leading Institution: Faculty of Biology, University of Belgrade

Description of the project:

The principal goal of the project is to verify if, and to what extent, anthropic impact and climatic changes affect the risk of vector borne diseases transmission. The project aims to develop an epidemiological model where the environment is modeled on both italian and serbian characteristics, the wild animal host is the red fox, and the pathogens cause vector-borne diseases. The diseases considered are transmitted by mosquitos (Dirofilaria immitis), by ticks (Babesia sp. Ehrlichia sp., Anaplasma phagocitophylum), and by sandflies (Leishmania infantum). The pathogens to be studied were chosen because they are very different from the phylogenetic and biological points of view and in their ecological needs. In this way it will be possible to verify the large number of mechanisms through which environmental changes can affect the spread of pathogens.

Тип пројекта:

International Projects

Importance of Wild Canids as Hosts and Reservoirs for Ticks and Tick-Borne Pathogens in Austria and Serbia

Project leader: Dr. Snežana Tomanović, Dr. Georg Duscher

Project collaborators: Dr. Darko Mihaljica, Dr. Ratko Sukara

Project number:

Duration of the project: 2016-2017.

Leading Institution:Institute for Medical Research, University of Belgrade

Description of the project:

Identification of ticks and tick-borne diseases, as a growing problem in last decades, coincides with the increase of anthropogenic influence on biotic and abiotic components of ecosystems. As a result of direct and indirect anthropogenic impact, the migration of these pathogens to new areas is enabled. Wild canids are important hosts of ixodid ticks and recently they have been recognized as potential reservoirs of several tick-borne pathogens of zoonotic and domestic animals importance. The species like red foxes (Vulpes vulpes) and golden jackals (Canis aureus) also represent an important source of infections for domestic animals and humans, mostly due to their close proximity to human settlements and frequent exposure to different vector species. Currently, these populations are both still rapidly growing in urban areas and spreading their ranges toward Central and Eastern Europe increasing the risk of human and animal exposure to pathogens. However, many aspects of the epidemiology of tick-borne diseases in wild canids, such as host range, tick range and their geographical distribution are still poorly understood.

Тип пројекта:

International Projects

Преглед мера превенције и процена оптерећења токсоплазмозом код трансплантираних пацијената у европским земљама

Води : др Florence ROBERT-GANGNEUX,

Сарадници на пројекту:

Др сци Олгица Ђурковић Ђаковић, Др Тијана Штајнер

Број пројекта: grant (P307-09) from ESCMID

Трајање пројекта: 2014 – 2016.

Водећа институција: Универзитет у Рену, CHU Rennes, Француска

Опис пројекта:

Број трансплантације се повећава, што доводи до све већег броја пацијената под ризиком од токсоплазмозе. Анализирани су пракса превенције токсоплазмозе, преваленца и исходе за пацијенте са трансплантацијом хематопоетских матичних ћелија (HSCT) и трансплантацијом солидних органа (SOТ; срце, бубрег или јетра) у Европи. Прикуплјени су електронски подаци о трансплантираној популацији и смернице/прописи за превенцију и клинички подаци о случајевима токсоплазмозе дијагностикованим током 2010–2014. Серолошки претрансплантацијски скрининг давалаца алохематопоетских матичних ћелија обављен је у 80% земаља, скрининг донора органа у 100%. Примаоци су систематски прегледани у 6 земаља. Циљана хемопрофилакса против токсоплазме била је хетерогена. Забележено је укупно 87 случајева токсоплазмозе (58 ало-ХСЦТ, 29 SOT). Шестомесечна стопа преживљавања била је нижа међу серопозитивним примаоцима на токсоплазму и међу примаоцима алохематопоетских матичних ћелија и јетре. Хемопрофилакса је побољшала исходе за примаоце SOТ. Токсоплазмоза је и даље повезана са високим стопама смртности међу примаоцима трансплантације. Хитно су потребне смернице за стандардизацију профилактичких режима и оптимизацију управљања пацијентима.

Тип пројекта:

International Projects
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