PSE@GCT

Background

The German Federal Ministry of Education and Research (BMBF) has commissioned the Berlin Institute of Health (BIH) to bring together relevant stakeholders from Germany, in order to develop and implement a National Strategy for Gene and Cell based Therapies (GCT). A particular focus is on integrating the patients’ perspective from the beginning and throughout the entire process.

In close consultation and collaboration with the National Network Office for Gene and Cell Based Therapies, the Patient & Stakeholder Engagement (PSE) Team of the BIH QUEST Center, and the patient and self-help organizations as well as patient representatives that are already involved in the strategy process, measures will be implemented to ensure that patients’ and stakeholders’ perspectives are considered throughout the entire process. The aim is to involve patients and other stakeholders in projects at an early stage and to engage them actively.

Realization of the Project

An initial project involves mapping patients and self-help organizations in Germany and representing them in the GCT-Atlas, which is being developed by the Network Office. The GCT-Atlas will be used as a nationwide location map, showing various stakeholders such as university hospitals, Good Manufacturing Practice (GMP) facilities, professional societies, foundations, patient registries, patient and self-help organizations in the GCT sector. For example, the first collection will clearly show patients centers where GCT is offered. The Atlas will also facilitate networking between patients, researchers, clinics and other partners.

Furthermore, patient engagement is ensured throughout the entire (research) process. It is necessary to involve patients in the early stage of the (research) processes to consider their needs and perspectives properly and to be able to integrate them into the design of research projects and clinical studies. For this purpose, evaluation criteria for project proposals and registries regarding patients’ and stakeholders’ engagement (PSE) are developed. In addition, researchers and other stakeholders will be informed about the planning and implementation of PSE via consultation and training services.

Another aspect of the project is creating and disseminating information and trainings on GCT that are understandable to non-professionals in collaboration with the involved patient representatives.

Implications and Perspectives

The National Network Office for Gene & Cell Based Therapies and the PSE Team of the QUEST Center will develop further measures for the institutional establishment of PSE at BIH. Furthermore, the exchange and cooperation with already existing networks and working groups in the field of PSE will be strengthened in order to develop patient engagement further and implement patient engagement on the national level.