Projects

Diagnosis and monitoring of reactivated toxoplasmosis (RT) in HSCT recipients was introduced into the transplantation practice in Serbia in 2013 (cooperation of the Mother and Child Health Care Institute and the NRL for toxoplasmosis). Despite its many benefits, clinical experience with this approach to control T. gondii infection in HSCT patients has also revealed gaps including diagnostic challenges pertinent for decisions on treatment, and lack of consensus on the frequency and duration of blood sample monitoring by qPCR after HSCT, respective of clinical setting and administration of prophylaxis. Thus, the goal of the proposed project is to, after standardization and harmonization of the qPCR protocol in both partner laboratories, identify subgroups of patients (according to the clinical setting, type of prophylaxis etc.) at the highest risk of RT, that would benefit the most from systematic PCR monitoring, with the final outcome to devise a cost-effective alternative for the prevention of RT after HSCT.

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 the 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 on 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 a 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 Open 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.

Olgica Djurković-Djaković, Ivana Klun, Aleksandra Nikolić, Branko Bobić, Aleksandra Uzelac, Irena Rajnpreht

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).

from the Serbian side: Dr. Olgica Đurković-Đaković, from the French side: Prof. Florence Robert-Gangneux

dr Tijana Štajner, dr Jelena Srbljanović, Neda Bauman, Aleksandra Uzelac

Diagnosis and monitoring of reactivated toxoplasmosis (RT) in HSCT recipients was introduced into the transplantation practice in Serbia in 2013 (cooperation of the Mother and Child Health Care Institute and the NRL for toxoplasmosis). Despite its many benefits, clinical experience with this approach to control T. gondii infection in HSCT patients has also revealed gaps including diagnostic challenges pertinent for decisions on treatment, and lack of consensus on the frequency and duration of blood sample monitoring by qPCR after HSCT, respective of clinical setting and administration of prophylaxis. Thus, the goal of the proposed project is to, after standardization and harmonization of the qPCR protocol in both partner laboratories, identify subgroups of patients (according to the clinical setting, type of prophylaxis etc.) at the highest risk of RT, that would benefit the most from systematic PCR monitoring, with the final outcome to devise a cost-effective alternative for the prevention of RT after HSCT.