Executive Summary of Public Deliverables
This document presents the TAXINOMISIS First Subject Approvals Package which provides detailed information on the procedures that will be implemented for patient recruitment to the prospective clinical study protocol.
Since the initiation of the project on January first clinical partners communicated in order to define optimal protocol for clinical study that is part of Taxinomisis project and deliverable D5.1. At the end of January, during the kick off meeting the inputs for the study protocol were discussed among Consortium. The main goal of the study is to validate and adjust a stratification tool that will be defined from longitudinal studies in WP3. Data extracted from huge registries will be used to stratify patients with carotid disease in order to define those who are at increased risk of stroke when preventive surgery is beneficial. During the kick of meeting, all partners discussed the optimal manner to conduct clinical trial and which are the most important data to be delivered from this trial. Non clinical partners proposed parameters of interest for stroke in patients with carotid disease that should be validated in clinical trial.
During the kick off meeting, UBEO and Igor Koncar were elected to coordinate the study with the purpose to lead the clinical study from development of protocol to study conduction. After the kick off meeting clinical partners leaded by UBEO exchanged and discussed three consecutive versions of the clinical trial protocol that were additionally discussed in teleconferences with clinical and nonclinical partners. Study protocol accurately describes inclusion and exclusion criteria, primary and secondary endpoints and methods of patients’ examination and follow up visits. All these parameters were thoroughly discussed among clinical partners and evaluated by the teams of each clinical partner.
Patients with inclusion criteria will be examined (blood tests, ultrasonography and MRI of carotid bifurcation and MRI of the brain, carotid plaque sample analysis) while entering the clinical study and will be followed for three years with the same annual examinations. During that time primary and secondary endpoints will be followed and compared with those expected from developed stratification tool delivered from longitudinal data of huge registries that are already available in non-clinical partners. The study protocol was discussed with ESCVS representatives that will assess this trial from legal and ethical point of view.
Finally, the clinical trial protocol was accepted by all the clinical partners, approved by the Ethical board of University of Belgrade and the Clinical trial was submitted in registry for Clinical trials. The first patient of this clinical trial was recruited in UBEO on 30th of March 2018
In the following time, the clinical study will be approved by all the local Ethical committees of the clinical partners and patients’ recruitment will start in all participating centers. The study protocol defined the recruitment committee that will schedule a conference call during M4 and discuss further recruitment goals of all individual partners in the following 14 months.
This document is the TAXINOMISIS midterm recruitment report for the project’s prospective observational clinical study. The report provides an overview of the research participants recruited so far, by each clinical centre, any problems encountered during the process and a detailed description of measures planned to be implemented to compensate any delays in the study’s subject enrolment goals.
Since the initiation of the project in January 2018, the clinical partners have defined the optimal protocol for the clinical study, part of the Deliverable D.5.1. Dr. Igor Koncar was chosen as study coordinator with the purpose to lead the clinical study, from the development of the protocol to the conduction of the study. The clinical study protocol accurately describes the inclusion and exclusion criteria, the primary and secondary endpoints and the methods of patients’ examination and follow-ups. The clinical study protocol has been discussed with the ESCVS partner that oversees this trial from the legal and ethical point of view. The protocol has been accepted by all clinical partners, approved by the Ethical board of the University of Belgrade and the Clinical trial has been registered in an international registry for clinical trials under the reference number NCT03495830 (www.clinicaltrials.gov). The first patient of the clinical trial was recruited in UBEO on the 30th of March 2018. The procedures for patient recruitment have been initiated in all participating clinical centres, after receiving the appropriate Ethical Approvals by the competent Ethics committees, except for the partner UMC UTRECHT as the decision of the corresponding Ethics committee is still pending, due to additional mandatory procedures and documents required. In addition, the protocol has defined a committee responsible to address problems and discuss further recruitment goals, for all clinical partners, in the following months of the recruitment period. Each collaborating clinical centre has projected a number of recruited patients and estimated a monthly rate of enrolment until M18, when recruitment is estimated to be finalized. Collectively, by December 31st 2018, 88 patients have been recruited in UBEO, TUM-Med, N.K.U.A. and FCRB. As far as the quality of imaging data is concerned, a representative image (non-identifiable data), for each image modality used in each centre, has been approved by the study coordinator. Although, delays have been encountered mainly due to time-consuming procedures to acquire ethical approvals and due to different equipment specifications needed for image acquisition, the overall recruitment rate is considered acceptable and estimated to increase with the full engagement of the rest of the clinical partners to the recruitment process within the next months. Finally, the project coordinator (UOI) has developed the electronic Case Report Form (eCRF) platform which is necessary for data collection and management using the infrastructure services (IaaS) of a cloud provider engaged as a third-party processor under a contract compliant with Article 28 of the EU’s General Data Protection Regulation (GDPR). More specifically, the Greek Research and Technology Network (GRNET) has been added in the consortium as a third party providing in-kind contribution free-of-charge to the coordinator UOI (art. 12 of the Grant Agreement).
TAXINOMISIS progress and outcomes will be disseminated in a way that will appropriately address the target audiences on all stages of the project and create a lasting impact in the European economy and the public audience. This deliverable deals with the TAXINOMISIS presentation material developed during the first six months of the project (January 1st, 2018 – June 30th, 2018). TAXINOMISIS logo, press release, brochure, flyer, poster, social media and website are presented which will be updated according to the needs of the project within its lifecycle. The presented activities fulfill the initial dissemination activities plan of the project as presented in the DoA.
The aim of D8.1: Project handbook, risk management and quality assurance plan is to provide TAXINOMISIS consortium with the overall description of the management structure, including the main activities to ensure the Consortium compliance with EU regulations and their contractual and legal requirements, to manage and control project objectives, resources, schedules and activities and ensure the integration of administrative related tasks. This report also presents the project periodic reports, including management report, report on the distribution of funds, financial and audit certificates, communication with the European Commission concerning administrative and managerial issues (i.e. financial issues, contract amendments, reporting).
Therefore, each partner can use the project handbook to retrieve information for the project management rules that the TAXINOMISIS consortium as a whole will follow to ensure a high project quality and effective cooperation. The proper implementation of these rules is a responsibility of the Project Coordinator.
This project has received funding from the
European Union’s Horizon 2020 Research and
Innovation Programme under grant agreement No