The public-private partnership, READI, seeks to help clinical studies (CS) to finally serve the complete general population, and therefore more patients. To date CS have struggled to recruit and retain participants from diverse backgrounds and communities, such as marginalized or disadvantaged groups (e.g., sexual, gender, age, cultural, and socioeconomic cohorts). The resulting knowledge gaps entrench or increase health disparities. The READI consortium strives to tackle these challenges by fostering a more cohesive and integrated CS ecosystem for underserved (US) and underrepresented (UR) communities. It will actively connect all key stakeholders who can facilitate access to a wide range of patient populations. It will provide these stakeholders with the necessary tools, training programs, and approaches essential for the recruitment and retention of US/UR patients in CS. In addition, it will design, build and implement a digital platform which is patient-centred, sustainable, open and innovative. This will foster improved access to CS information and READI tools, while also supporting patient connections with the created communities. Finally, at least 4 CS will be used for testing the effectiveness of the developed tools and approaches. READI has a three-fold objective: to help US/UR communities overcome CS participation barriers (e.g., lack of information/awareness, mistrust, poor communication, geographic limitations, prejudice), which in turn will improve research of many diseases and conditions, preventative care and treatment effectiveness in different demographic groups, and better serve society. READI’s success will draw from its interdisciplinary, multi-stakeholder, consortium composition of 73 organizations from 18 countries, with key expertise in drug development and CS (design and operations), engagement strategies for US/UR populations, digital platform development, training and capability building initiatives, effective communication and dissemination, long-term sustainability, ethics and regulatory affairs.

Share4Rare is a collective awareness platform of patients, caregivers, researchers and other stakeholders involved in the Healthcare of Rare Diseases (RD). Based on a socially innovative approach, and building on citizen science and collective intelligence, we will engage and connect all the relevant stakeholders, towards the improvement of the quality of life, the management and the collection of scientific knowledge. The platform will be built around three important pillars: care, education and research. Our Collective Awareness Platform will take advantage of the high-motivated group of citizens (from patients to researchers, from volunteers to public health representatives and health professionals) linked or not to rare diseases, and their expertise. It will build on existing knowledge and initiatives, and will ensure a space for debate and co-creation, and a space for further research. S4R will be based on the shared open data, and on the priorities set collectively. Collective intelligence from patients and families, democratic and transparent participation and a secure environment focused on three layers of interaction will ensure a platform to put in value citizen science that is needed to promote new research initiatives with a patient centred approach.

The Gravitate-Health mission is to equip and empower citizens with digital information tools that make them confident, active, and responsive in their patient journey, specifically encouraging safe use of medicines for better health outcomes and quality of life. It is our vision that engagement of citizens in their own health can only be achieved with access to actionable, understandable, relevant, reliable and evidence-based information that meets their specific needs, health context, and literacy level. This project's ambition is to provide a key piece to advance this vision: the Gravitate Lens (G-lens), which focuses (but does not conceal or filter) approved electronic product information (ePI) content, and offers a route for patients to access trustworthy, up-to-date information that better meet their individual needs. Gravitate-Health is an integrated digital health information project. The principle objective is to demonstrate how use of an integrated, digital, user-centric health information solution with two-way communication could enable tangible improvements in availability and understanding of health information from a set of trusted sources, starting with regulator-approved medicinal product information (e.g. package leaflet content) and EHR-IPS (International Patient Summary). The secondary objectives are to demonstrate that the improved availability and understanding of health information from trusted sources translate to higher levels of adherence to treatment, safer use of medication (Pharmacovigilance), better health outcomes and quality of life, and to develop new and deeper insights into how use of available health information can be optimized to act as effective risk minimization measures. The project allows for efficient and timely development of the G-lens, provides testing grounds for new services and an evaluation framework to test the efficiency, efficacy and safety of Gravitate-Health services. Our main outputs will be an open source digital platform supporting G-lens functionally, demonstrated in a number of testing scenarios, and a White Paper with recommendations on realistic strategies to strengthen access, understanding and future use of digital services like ePIs as a tool for Risk Minimization. The Gravitate-Health is a public – private partnership with 45 members from Europe and the US, co-led by University of Oslo (coordinator) and Pfizer (industry lead), funded by the Innovative Medicines Initiative (IMI) – a joint undertaking of the European Commission, the European Federation of Pharmaceutical Industries and Associations (EFPIA), IMI Associated Partners.

SYNCHROS (SYNergies for Cohorts in Health: integrating the ROle of all Stakeholders) coordination and support action aims to establish a sustainable European strategy for the development of the next generation of integrated population, patient and clinical trial cohorts, thereby contributing to an international strategic agenda for enhanced coordination of cohorts globally. This will address the practical, ethical and legal, and the methodological challenge to optimising the exploitation of current and future cohort data, towards the development of stratified and personalised medicine as well as facilitating health policy. In order to achieve this objective, SYNCHROS will map the cohort landscape in Europe and large international initiatives, identify the best methods for integrating cohort data, identify solutions for addressing practical, ethical and legal challenges in integrating data across patient, clinical trial and population cohorts, and evaluate the use of emerging and new data collection technologies and types of data. Together with intensive stakeholder involvement (researchers, patients, funding bodies, clinicians, coordinators of previous harmonization and integration exercises), strategy briefs will be written and used to conduct stakeholder dialogues to generate consensus following a deliberative process and implementation science methods. We aim to make sustainable recommendations on standards to improve future sample, data collection and data sharing methods and disseminate this information so as to contribute to defining an international strategic agenda for better coordination of cohorts globally. SYNCHROS partners include a large range of expertise from epidemiology and clinical research to legal/ethical issues and anthropology, international organizations such as WHO and European infrastructures such as ECRIN.

Advancing personalized approaches in cancer therapy, aiding identification and adaptation of multi-modal treatment strategies for improved outcomes depends on clinical implementation of novel diagnostic technologies. For most cancer types the risk-features used to select individuals for post-operative adjuvant multimodal therapy are suboptimal, where many patients are overtreated and others undertreated. Liquid biopsy has opened a new diagnostic avenue to detect and monitor minimal residual disease (MRD) in individual cancer patients, especially for selecting patients for multi-modal therapies post-operatively. However, despite many circulating tumor DNA (ctDNA) diagnostics being developed there is a lack of standardization, harmonization, and robust data to demonstrate clinical validity. GUIDE.MRD is a consortium of leading academics, technology companies, pharmaceutical companies, and experts in multi-stakeholder engagements. Together, we will tackle the critical questions by developing reference standards for ctDNA diagnostics, clinically validate promising ctDNA diagnostics and develop data to guide the use of multi-modal therapies with a non-invasive diagnostic test. With robust engagement with regulatory authorities, payers and importantly patients themselves, we will develop recommendations and guidelines based on objective data to use ctDNA diagnostics to guide multi-modal therapy selection to improve patient outcomes.