Task 1.1 Project Management AOPD has a proven track record of administrative and financial management of large national and international projects (more than 40 International Projects – with 10 proj...
Task 1.1 Project Management AOPD has a proven track record of administrative and financial management of large national and international projects (more than 40 International Projects – with 10 projects ongoing with the role of Coordinator in 2). The Unit “Progetti e Ricerca Clinica” (UPRC) is an AOPD structure dedicated to research projects management. Supported by this Unit and a dedicated project manager the Coordinator will monitor the progressive development of the project. They will manage all aspects of scientific and financial reporting, assist the financial department in the budget administration and represent the contact point for all partners. They will also organize the consortium meetings.
Task 1.2 Project management team The PMT consists of the project coordinator, UPRC representative, project manager and WP leaders. This group will monitor the project implementation within the frame of the Grant Agreement.
Task 1.3 Meetings A kick-off meeting will be organized in month 1; participants will receive an informative package including a project overview, schedules, reporting and financial guidelines and templates. Consortium meeting will be held every six months to support the project implementation. Parents representative will be invited to give their contribution
Task 1.4 Communication Besides consortium meeting, bimonthly teleconferences (or more often if required) will be organized.
Dissemination of the project by lead CCRI
Start month:1 - End month: 36
CCRI, as the Coordinating institution of the ERN PaedCan will be the work package leader in providing a European platform for dissemination and promotion of the aims and outcomes of the PARTNER projec...
CCRI, as the Coordinating institution of the ERN PaedCan will be the work package leader in providing a European platform for dissemination and promotion of the aims and outcomes of the PARTNER project. Through the ERN PaedCan network CCRI will carry out the dissemination activities in collaboration with the European Society of Paediatric Oncology (SIOPE). SIOPE and CCRI have established over the years an effective working relationship through various EU funded projects, coordinated by CCRI (ExPO-r-Net, ENCCA, etc.). SIOPE brings the necessary expertise and long-lasting track record in the dissemination of several EU-funded projects in paediatric oncology. Some of SIOPE’s services in this WP will ensure continuity of activities from other relevant EU-funded projects and avoids fragmentation.
Task 2.1 – Project communication tools CCRI will develop in collaboration with SIOPE a communication strategy plan to ensure continuity with other initiatives in the field of paediatric oncology and innovative therapies. Communication target groups for this project will include all health professionals involved in paediatric haemato-oncology (paediatric oncology researchers, healthcare professionals, academic experts, nurses, and adult oncologists), parents, patients and survivors’ representatives, but also project partners, EU policy-makers, industry, regulators and the broader European cancer stakeholders’ community. Following communication tools should be created: • PARTNER logo; • PARTNER brochure; • PARTNER banner (roll-up); • PARTNER PowerPoint template for project partners; • PARTNER 1-page factsheet and presentation for project partners (to disseminate the project at external meetings); • PARTNER news disseminated via emails and integrated in the SIOPE newsletter; • PARTNER updates integrated in the SIOPE social media tools.
Task 2.2 – Inclusion of PARTNER in the EXPeRT public website To stimulate communication, the PARTNER project will be integrated in the existing EXPeRT website, to ensure continuity with the European activities already carried out in this area. Responsibility for maintaining the website will be by partner 1 ’Azienda Ospedaliera di Padova’, in collaboration with CCRI and other WP leaders. The website section focusing on ‘PARTNER will include general information and updates on the progress made by the project. For sharing of data within the consortium the ERN intranet will be used. Since all partners are included in the ERN PaedCan the ERN intranet offers a private online space for sharing of data among the whole PARTNER consortium. The intranet will allow project partners to share and stock documents, attend project meetings and organise forums to discuss special issues online. It will enable on-line entry, display and transfer of results to be available to all participants, and it will also serve as a repository of the project’s internal documents (e.g. contractual documents, reporting templates and instructions, deliverables classified as “confidential” or “restricted”, etc.).
Task 2.3 – Project promotion at events Project promotion and relevant information to political decision makers as well as to the scientific and clinical communities involved in (paediatric) oncology will be carried out in collaboration with SIOPE. This is crucial for raising awareness about the need to adopt a new research approach to increase knowledge of the effectiveness of best available cancer therapy in childhood and obtain the highest possible survival across Europe. CCRI in collaboration with SIOPE will be responsible for the following: PARTNER project will be promoted during the main European events related to paediatric and adult oncology, including: • The ECCO European Cancer Congress and the Congress of the European Society for Medical Oncology (ESMO); • The SIOPE International Childhood Cancer Awareness Day, and other events organised by SIOPE in the European institutions; •
Evaluation of the project by lead CCRI
Start month:1 - End month: 36
Task 3.1 - Creation of the Quality Assurance Plan Document will guide the successful implementation of the project by setting the evaluation guidelines to measure the project progress and to set outco...
Task 3.1 - Creation of the Quality Assurance Plan Document will guide the successful implementation of the project by setting the evaluation guidelines to measure the project progress and to set outcome indicators for evaluation.
Task 3.2 - Undertake the continuous evaluation of the project management and internal processes. Feedback will be provided to project partners for corrective action, if needed (monitor-review-remedy model). Indicators will include frequency of deadlines being met to deliver reports; participation in meetings and telephone conferences; and internal audit of project targets and resolution of problems. We will focus on solution-based monitoring and evaluation processes.
Task 3.3 - Systematic appraisal of the quality of the project. This will assess the utility of project outcomes to meet user needs. A cohort of healthcare professionals, patients and families, policy makers will be approached with questionnaires, to evaluate the utility and progress of the project outcomes. Examples include the utility of the planned deliverables, i.e., establishment and activation of the PARTNER registry, the integration of the EUPID system for initial and continued data linkage via the EUPID App respecting all data protection rules, etc.
Task 3.4 - Systematic appraisal of the effects of the project. Measures will include assessment of public dissemination (on-line review of e-media), impact on public policy documents.
Analysis and harmonization of data acquisition of the existing national VRT registries by lead EKUT
Start month:1 - End month: 18
Tasks 4.1 - Identification of registered tumour entities and variables Within EXPeRT detailed data on VRT have been collected over years into national registries within France, Germany (including Aust...
Tasks 4.1 - Identification of registered tumour entities and variables Within EXPeRT detailed data on VRT have been collected over years into national registries within France, Germany (including Austria), Italy and Poland. In the past data were retrospectively harmonized in order to allow pooled analyses. To increase the quality of data and to allow for common analyses of significant patient cohorts, the goal is a harmonized prospective data collection. The basis for establishing a common European registry (WP5) is the harmonization of the data collection of the existing European registries. In a first step, the national registries have to report the tumour entities and variables included in their national data registries. The goal is to reach an agreement of coordinators of the existing registries on the entities to be collected and the variables This shall be done in close cooperation with partners from WP5 and IT experts.
Task 4.2 - Agreement on tumour entities and variables prospectively registered in future PARTNER The basis for establishing a common European registry (WP5) is the harmonization of the data collection of the existing European registries in terms of entities and data points. There will be a decision making process in order to find an agreement. IT partners will be involved in order to take technical aspects / data base structure into account. A consensus meeting will be performed with all EXPeRT partners and new LHEAR partners (cooperation with WP 6). The WP leader will develop a core data sheet, which will be circulated among the national groups. In a second working meeting the core data sheet will be consented.
Task 4.3 - Report and recommendations on harmonized procedures of primary source data verification, registration and documentation The procedures regarding primary data source verification, quality control (e.g. central review procedures) and data management existing in the different national registries will be analysed. The WP leader will prepare a detailed report and recommendations for harmonization of data verification, registration and documentation in collaboration with WP5. In addition, a list of duties for a subcontracting IT partner will be prepared, which will be transferred into WP 5 (MS 4.3).
Task 4.4 - Preparation of a list of variables from the virtual consultation system for integration into the PARTNER data base Within this WP, a list of parameters will be defined, which will be selected for transfer into the PARTNER database. These parameters will be harmonized with the data from national data bases (in patients from countries with national data bases) to prevent parallel data transfer (harmonization within task 4.1). Moreover, additional data on the consultation process and follow up information evaluating the consultation process will also be identified and integrated into PARTNER.
Creation of a European registry for paediatric patients with very rare tumours by lead AOPD
Start month:1 - End month: 36
Four national registry dedicated to children with VRT exist in France, Germany (including Austria), Italy and Poland. They are managed by national cooperative groups endorsed by their respective natio...
Four national registry dedicated to children with VRT exist in France, Germany (including Austria), Italy and Poland. They are managed by national cooperative groups endorsed by their respective national paediatric oncology societies. In the last decades these registries have collected a significant amount of clinical, biological and treatment data leading to a series of publications in a field where studies were extremely scarce (4-19). To increase the capability of analysing a significant number of patients collaboration among the existing cooperative group has been launched in 2004 and the EXPeRT has been created. As initial step EXPeRT decided to join data collected on a national level on a series of different VRT. Results of this collaboration have been published (21-24). However data were collected in a retrospective way and no common registry was established. Based on the harmonization work performed in WP4 this WP will establish a common European registry and will link to it the existing national registries.
Task 5.1 - Development of the PARTNER structure Using the core data set identified in WP4 a web-based Registry will be developed using a rigorous methodology for collecting, monitoring and analysing health data, ensuring the standardization of procedures, and the security and integrity of information. The registry platform should allow high levels of configurability, definition of data workflow, profile-based access, a historical database of all the changes to the database and tools for managing data quality through a system of checks and warnings. The system should support quality controls during data entry to prevent input errors as much as possible and have reporting tools. Patients’ data, identities and all transactions should be protected through encryption, secure communication channels and strong authentication. Finally the system will be equipped with all the technological components that enable the exchange of data with external systems according to the main interoperability standards used in health care domain, such as HL7 and DICOM. On this basis, interoperability is possible in compliance with the standard frameworks IHE and CDISC. The adoption of these standards will guarantee the possibility to connect PARTNER with the European IT platform that is in preparations for all the European Reference networks.
Task 5.2 - Development and integration of EUPID. After analysing the characteristics and interoperability capabilities of the existing VRT registries, the PARTNER App will be designed and developed as the tool to link the existing VRT databases with the EU database. The adoption of EUPID will guarantee pseudonymisation and privacy preserving record linkage and secure data transmission from national registries to PARTNER. The EUPID system will be used also to link PARTNER with the virtual consultation system based on the preparatory work done on WP4. The EU-PID development will includes user training and support. To develop IT tools collaboration is foreseen with the Austrian Institute of Technology (AIT) and CINECA, a non-profit inter Universities consortium based in Bologna, Italy. The advantage and necessity if this collaboration relay on the fact that a) the EUPID system has been developed by AIT and it is already used in an increasing number projects in the European Paediatric Oncology community, b) the virtual consultation system for VRT has been developed by CINECA during the ExPO-r-Net project. In addition, CINECA and AIT have already worked jointly to support the interoperability of their systems during other EU-funded projects (ENCCA and ExPO-r-Net).
Standard of care recommendations for children with VRT by lead CURIE
Start month:1 - End month: 36
Treatment of paediatric VRT may be challenging because due to the low number of cases experience may be scarce even in the largest paediatric oncology centres. Defining the standard of care for paedia...
Treatment of paediatric VRT may be challenging because due to the low number of cases experience may be scarce even in the largest paediatric oncology centres. Defining the standard of care for paediatric VRT is therefore important to offer the best chance of cure to patients and homogenise treatment across Europe. Due to the rarity of VRT in children no clinical trial based evidence exists. Therefore, consensus recommendations for VRT will be developed based on the evidence collected from published series, case reports and the EU experience based in data extracted from the national registries.
Task 6.1 - Establishment of a Working Group A multidisciplinary working group coordinated by the WP leader and including associated partners and LEHAR countries representatives will be created to coordinate the activities, decide the methodology and timelines and assure that the defined standard of care may be applicable in every EU member state.
Task 6.2 - Creation of a VRT list Tumours of interest will be identified on the base of their relevance, previous EXPeRT experience, (i.e. data analysis and publication) and literature data. Priority will be established.
Task 6.3 - Elaboration of standard of cares documents The working group will designate two coordinators will for each identified tumours that after working group discussion will elaborate a first draft of the document. After further among WP members and revision from external experts subsequent draft will be elaborated until the final draft will be agreed on in a consensus meeting. The final draft will be summited for publication to a peer-reviewed journal to assure appropriate dissemination. At least 4 VRT standard of care documents will be elaborated during the project.
Integration of LHEAR countries in a EU platform dedicated to VRT in paediatric age by lead GUMed
Start month:1 - End month: 36
The majority of EU countries do not have a registry to collect data on children and adolescents with VRT. This is particularly true for LHEAR countries where the low number of patients with VRT does n...
The majority of EU countries do not have a registry to collect data on children and adolescents with VRT. This is particularly true for LHEAR countries where the low number of patients with VRT does not justify the employment of human and economic resources to develop registries. Only Poland has a national Group dedicated to VRT and a national registry. This is partly explained by the fact that collaboration between Poland and other EU countries exists since many years, so the Polish group has been involved in EXPeRT since its foundation. This same collaboration needs to be extended to other countries in order to improve VRT patients care
Task 7.1 - Creation of a VRT Working Group consisting of project associated members and LHEAR countries representatives. This task will require the identification through the national PO societies of the most active/leading PO centres in particular LHEAR countries, involved in VRT diagnosis and treatment
Task 7.2 - Creation of a standardized questionnaire to define the LHEAR Countries current activities and needs in the field of paediatric VRT The questionnaire will be sent to the members of the LHEAR VRT Working (Core?) Group identified in Task 1 and further disseminated by them to the appropriate PO centres, where the diagnostics and management of VRT takes place. The data extracted via the questionnaire should enable to identify if there is any kind of VRT patients registration (i.e. general cancer registries hospital registries). In countries where some kind of VRT registration exists the questionnaire should be able to assess the definition used, the list of information collected and the technology used. In addition the questionnaire should be able to a) identifying possible obstacles for LHEAR countries to contribute data to the international Registry for paediatric VRT b) assess which types of VRT can realistically included in the international registry possible c) the estimated coverage of these collected data in comparison to the expected cases.. Social, ethical and cultural as well as economic differences will be identified and described for each country surveyed.
Task 7.3 - Inclusion of LHEAR countries in the creation of the VRT platform delineated in this project (in collaboration with WP5)
Task 7.4 - inclusion of LHEAR countries representatives in the elaboration of standard of treatment recommendations (in collaboration with WP6) This collaboration will aim to make the standard of care recommendations as much as possible applicable in LHEAR countries and provide documents translation for better dissemination.