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Good Practices for demonstrating safety and quality through recipient follow-up [Euro-GTP II] [709567] - Project
Project abstract

The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective implementation.
The outputs of this project will provide tools for assessing and verifying the quality, promote safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly to the implementation of novel T&C preparation processes and clinical indications, but also to the need of retrospective studies where weaknesses or insufficient safety data currently exist.
Recommendations will be forwarded to Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), as the main actors in the process of validation and designing T&C preparation processes and patient follow-up according to a clinical indication.
This project aim to define the threshold of novelty, including definition of the factors that should be considered to determine the scope and depth of the clinical follow-up studies needed. The scope and extent of the recommended studies will be determined on the basis of a risk based approach performed taking into account factors such as the novelty of the product/preparation process/clinical indication, and its technical complexity.
A T&C Database of products, preparation procedures, clinical applications and their current status of authorisation and implementation will be established, working as a starting point for determining the ‘novelty’ of processes/therapies by TEs and ORHAs, and allowing the use of established processes/therapies by any centre that strictly follows the same procedure/clinical procedure/indication.
This project also aims to define a “GTP’s management model” that could provide impetus for future standards harmonisation and promotion, and allow the establishment of European accreditation and training programs for TE.

Summary of context, overal objectives, strategic, relevance and contribution of the action

Euro-GTP II aims to set up the good practices applied to Tissues and Cells (T&C) preparation processes and patient follow-up procedures to ensure their safe and effective implementation and evaluation.
Euro-GTP II will give continuity to the first EuroGTP project, which has developed European Good Tissue Practices for the activities carried out in tissue establishments (TE).

The outputs of the Euro-GTP II project will provide tools for assessing and verifying quality, promoting safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly the implementation of novel T&C preparation processes and clinical indications, but also the need for retrospective studies where weaknesses or insufficient safety data currently exist.

This project intends to assist TEs, ART centres and Organizations Responsible for Human Application (ORHAs), in the implementation of technical requirements defined for the assessment and verification of the quality, safety and efficacy of therapies with human T&C. Moreover, these tools will be developed in accordance with regulatory principles, legislation and good practices, and will be made available to National Competent Authorities (NCAs), hence facilitating also the evaluation and the authorization procedures.

Euro-GTP II will contribute to the (2014-2020) Health Program through the development of common European Good Practices required for human application of the tissues/cells in a safe and effective manner.

The four core work packages will determine:
- Methodologies for assessing the risk associated to novel tissues/cells and for assessing the extent of the studies needed to provide quality, safety and efficacy data for the tissues/cells applications.
- The follow-up programmes in order to assure safety and efficacy and to confirm the validation of the processing methods.
It is foreseen that project’s outcomes could contribute for:
a. The implementation and revision of EU legislation needed to regulate the studies extent needed to provide enough clinical validation data and recipient follow-up data, and to demonstrate the safe use of tissues/cells, as defined by the EU Directives 2004/23/EC and Directive 2006/86/EC;
b. Development of activities of TE and ORHAs according to methodologies and parameters that demonstrate the quality and safety of T&C products and therapies;
c. The better evaluation of the compliance of technical requirements by NCAs It will also promote knowledge and understanding of the role of standards and accreditation of T&C activities, encouraging the compliance of EU Directive and contributing for the harmonisation of practices across Europe, consequently increasing the safety of patients that require therapies with T&C.

Methods and means

The Kick-off Meeting officially introduced EuroGTP II’s goals, work plans, and presented the outcome proposals to all Associative and Collaborative Partners. This meeting was held in the presence of CHAFEA (Consumers, Health, Agriculture and Food Executive Agency) and DG SANTE (Directorate General for Health and Food Safety - European Commission) officers, and provided the opportunity to actively involve all consortium members, share the legal and financial requirements defined by CHAFEA for the good progression of the project, and better understand the European Commission’s expectations for the outcomes of this project.

During the first months of the project, Work Package (WP) 2 – Dissemination worked in direct collaboration with the Coordinators and WP leaders for the elaboration of contents and the production of the official website and leaflet. Once these main dissemination tools were ready to be disclosed, WP2 focused in ensuring the correct dissemination of the project amongst stakeholders and National Competent Authorities (NCAs), and gathering the information required for official presentations of the project (articles, oral presentations and other means of dissemination).

The evaluation of the kick-off-, Interim- and technical meetings was performed by WP3 – Evaluation. In addition to these seven evaluation procedures, WP3 Leaders developed the methodologies of audit procedures based on Appraisal of Guidelines for Research and Evaluation (AGREE), and drafted the structure of the technical annex that will be used in evaluation performed by the auditors. WP3 Leaders were also responsible for the monitoring of project’s progress, and the global interim evaluation.

The incorporation of technical input provided by partners and external experts is performed by WP4 – Coordination.
With the support of all Associative Partners, the Technical Questionnaire was disclosed at European Level.
Coordinators worked in parallel with Technical WPs (5, 6, 7, and 8) to develop the prototype of the Interactive Assessment Tool (IAT), draft the structure of T&C Database, and establish contacts and collaborations with the scientific associations and Council of Europe (CoE) for the future management of the project’s deliverables.
The development of “GTP’s Management Model” was addressed in several debates amongst consortium members, collaborating scientific associations (European Association of Tissue Banks (EATB), European Society for Blood and Marrow Transplantation (EBMT), European Eye Bank Association (EEBA), European Society of Human Reproduction and Embryology (ESHRE)) and the Council of Europe (CoE). The definition of the management model is not yet finalized, nevertheless three different aspects should be considered:
• Update of Good Practices defined;
• Update of algorithm and Database contents;
• Definition of Common Accreditation System for TEs.

The 1st Technical meeting of the WP5 presented and discussed the first proposal for the work methodologies for the development of Generic Good Practices for demonstrating safety and quality through recipient follow-up. WP5 Leader and the Coordinators (jointly presented a prototype of assessment methodologies, and promoted the discussion amongst the participants in order to obtain technical inputs from all partners.
Methodologies were further developed based on the inputs received in the first 3 technical meetings and the 1st draft of Generic Good Practices for demonstrating safety and quality through recipient follow-up was disclosed to all Associative and Collaborative partners.
The 4th technical meeting of WP5 focused on the validation of the IAT prototype and development of 3rd level of methodologies required to assess safety and efficacy of SoHO – Requirements of clinical evaluation and definition of follow-up programs.

Based on the contents developed by WP5 and the prototypes proposed by WP4, the WP6 - Good Practices for demonstrating safety and qua

Work performed during the reporting period

During the first months, coordinators focused mainly in providing adequate tools for sharing information, and determine the work plan for the project development and monitoring.
Associative partners were invited to register themselves in the web based management tool, which facilitated the sharing of documents and information amongst the participants. A tutorial document produced by the coordinators, provided assistance for registration and use of the management tool.
A dynamic Work Plan/Gantt Chart published on-line – this allows Associated Partners to follow the work done and the milestones accomplished. The Project Coordinator is responsible for the update of information in accordance with project progression.
Working Package Coordination: Definition of experts and participants involved in the different WPs and establishment of a Contact Directory – Associative Partners submitted the information related with the identification and contacts of the participants into a document published on-line and kept updated regarding any change in contacts and/or working groups
The Consortium Agreement was drafted by the Coordinators, formally signed by all partners and published in the management tool on April 22nd 2016. This document defines the rules that should be followed by all Associative Partners, in order to assure the compliance of CHAFEA’s procedures, promote collaboration amongst consortium members and resolve any conflict that may occur during the project.

In addition to the rules defined by the Consortium Agreement, a Follow-up Committee was established on April 2016. This Committee comprises of representatives from WP leaders’ organisations, and intends to:
• Monitor the work developed by the Euro-GTP II Project partners;
• Improve the quality of outcomes and deliverables;
• Assure compliance with the milestones and deadlines established by CHAFEA (in the Annex 1 (part A) of the Grant Agreement).

The logo and image of the EuroGTP II project was designed by a third party contracted by the Project Coordinators. These elements were utilised in the structure of the website and incorporated in all documents associated with the project.
The structure of the website was defined by the Project Coordinators and comprises two main areas: Public and Private Areas. The contents of the public area were produced by the WP2 Leaders in cooperation with all Associative Partners, and include all relevant information associated with: Objectives, WPs, Identification of Associated and Collaborative partners, and project outcomes. The public area of the website also fulfils the purpose of disseminating the public documents produced by the project (e.g. Newsletters and Leaflet).
Conversely, the private area intends to provide information related to the accomplished milestones, and serves as an archive for documents used and produced in the main technical and coordination meetings. An online forum is also part of the private area, and used mainly by the coordinators as a log for the registry of adopted decisions, namely the history of changes in functionalities of the IAT.
With the purpose of assisting WP Leaders and standardizing the records of the project’s activities, several template forms (minutes, presentations, agenda, milestones report) and supporting documents (meeting organisation checklist) were produced and published by the Coordinators.

The Financial Exercise consisted of the analysis of data reported by the Associative Partners through the Timesheets Partner Financial Statement Document. BST provided guidance (Guide for cost reporting and financial management), support to all questions submitted by Partners, and produced a summary report that foresaw to describe the funds spent.

The 1st technical questionnaire disseminated had the objective of identifying the current practices related to efficacy evaluation of Tissue and Cellular Therapies/Products (TCTPs) implemented by the EU stakeholders. 136 orga

The main output achieved so far and their potential impact and use by target group (including benefits)

The active involvement and endorsement of the scientific associations (EATB, EEBA, EBMT, ESHRE) is considered a great added value both for the development and promotion of the project’s outcomes.
The alignment of good practices with any future procedures to be defined by the NCAs is essential to assure the adoption of the outputs by the different stakeholders

Achieved outcomes compared to the expected outcomes

During the first half of the EuroGTP II project, we were pleased to achieve a close collaboration amongst all Associative and Collaborative Partners.
Globally the WPs were able to accomplish the majority of the milestones defined in the GA.
Despite the need for further development and refinement, both the key principles of the IAT and the 1st draft of the guide have been accepted by the participants in the project. The methodologies proposed seem to meet the needs of tissue bankers and clinicians, and are viewed as an effective means to assess and document the risks associated with novelty and changes in the activities of TEs.
The second half of the project will focus on the definition of the extent of studies required to mitigate risks resulting from change and novelty, which will complement the methodologies already developed and the development of the T&C Database.
Despite the structure of the future T&C database being still under discussion, its utility has already been acknowledged by the associative partners and scientific associations, for promoting communication and the exchange of knowledge amongst TEs.
• TEs will be able to share data, search potential collaborations (e.g. exchange of knowhow, participation in multicentre clinical studies), document/reference their efficacy and safety data, and search for references that sustain the risk assessment for the development of new TCTP.
• End users may use the database to search for therapies, and identify appropriate references relating to efficacy for them;
• NCAs can use the database during the evaluation of authorisation requests as a means to source data and compare the risk assessment under evaluation with those performed by other TEs for similar TCTPs.

Dissemination and evaluation activities carried out so far and their major results

The following activities have been carried out by the WP2, which is lead by the National Organization of Transplants (ONT), Spain:
• Identification of target groups
• Development of the dissemination and communication Strategic Plan, which includes the tools for implementing the strategy
• Production of the Logo and the EuroGTP II website, in collaboration with the Coordinators (WP1). The WP2 contributed to the website by providing the contents
• Dissemination of the project website
• Production and distribution of the EuroGTP II Leaflet
• Tracking the dissemination activities of the project, including those carried out by the partners.
• Production and dissemination of the Newsletter via the website, and also through the partners, Competent Authorities (CAs) and other stakeholders.
A total of 44 records for dissemination activities have been reported from June 2016 to September 2017 inclusive.
The associations which contributed to the dissemination, of the project itself or any other milestone, were: EATB, EEBA, EBMT, ESHRE and the European Society for Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA).
As regards the reported activities, there have been 20 national activities and 31 with international impact.

The actions of the evaluation WP include monitoring of the project activities, evaluation surveys and evaluator observation.
The monitoring of the project activities, with the objective of keeping project activities on track, was done with project management tool-Trello, the project website and CHAFEA shared documents. In total, seven evaluation reports were made, four defined in Grant Agreement and three additional. The full Interim Evaluation Report is published in the private area of EuroGTP II website.
Actions taken for evaluation of the project activities are as follows:
• monitoring of the project activities (milestones, deliverables, documents)
• template designed for meeting evaluation using online survey creator (SurveyMonkey Inc.)
• observation of the meetings by the evaluator
• continuous consultation with partners, WP leaders, project coordinator
• project deliverables are subjected to the Audit procedure