Consortium Partners

Work package 4-6; Expertise/capacity: Real-world data analyses/use, Ethical expertise, Communication and dissemination.

 

Within More-EUROPA, Charité mainly focuses on an ethical framework for generating and using patient-relevant real-world data to support regulatory decision-making. The main objective is to gain a good overview of the factors that play a role in the ethical use of RWD. A systematic qualitative review of literature and policies will be conducted as well as patient/stakeholder-interviews. An ethical framework for the ‘ethics of registry data use in regulatory decision making’ will be developed outlining practice-oriented standards for consent, use and access (and issues concerning de-identification), transparency, commercialization, diversity/gender and others. The framework development will engage patient-representatives and could help inform novel policies by shedding light on the ethical tensions inherent in using registry data for regulatory decision-making.
See also: More-EUROPA - Projects - BIH at Charité

Work package 5-6; Expertise/capacity: Real-world data analyses/use, Communication and dissemination.

C-Path supports communication and training for the efficient use of real-world data in the development, registration, and assessment of medicinal products in Europe as a partner in the More-EUROPA project.
See also: C-Path Europe

Work package 1-2 and 5-6; Expertise/capacity: Real-world data analyses/use, Registry owner, Communication and dissemination.

Partner organisation DICA is in the lead of More-EUROPA’s case study to improve the evidence for therapies using registry data as external controls in lung cancer. DICA is a hospital-based data base that operates since 2010, and started its medicines focused program in September 2018, currently capturing detailed prescribing information in 30,000 patients. The program evaluates the use of the therapies in daily clinical practice using existing data sources only. Data can be linked. With support from other partners, including IQVIA, a focus will be on securing data exchange within complex privacy legislation.

Work package 4-6; Expertise/capacity: Real-world data analyses/use, Patient engagement, Communication and dissemination.

EMSP is the leading voice in Europe advocating for people living with MS. Working with their members, partners, and people living with MS across the EU, they strive to influence policy decisions to ensure high- quality, equitable treatment, care, and resources for people affected by MS, and their inclusion in education, employment, and society as a whole. EMSP is also a driving force in the MS research agenda, ensuring coherence, engagement of people living with MS, and advancement towards their vision of a world without MS. EMSP brings together the unique expertise of its members and partners in Europe to drive critical, state-of-the-art research and advance MS-relevant policies and treatments, and possible cure. Their platform offers their members, EU decision-makers and opinion-leaders, and the wider MS community valuable evidence-based resources and tools to improve the lives of every individual living with MS in Europe. EMSP’s role in this project is leading work package 4 “Ethical perspectives and patient empowerment for RWD use”. Moreover, EMSP is in the lead of developing training content (e-learning modules and face-to-face dialogue with trainers) on how data from other sources than clinical trials can be shared and used using novel analytic methods, to inform regulators, HTA, clinicians, payers, patient organisations and also industry.

Work package 4-6; Expertise/capacity: Real-world data analyses/use, Patient engagement, Communication and dissemination.

 

Partner organisation EURORDIS brings to the More-EUROPA project their expertise in patient engagement, therapeutic development, regulatory and policy affairs. EURORDIS makes sure that patients are empowered and valued partners from the beginning to the end, adding the knowledge and overview only patients and their advocates can bring to the projects.

Work package 1-2 and 5-6; Expertise/capacity: Regulatory medicinal product evaluation, HTA/payer medicinal product evaluation, Real-world data analyses/use, Communication and dissemination.

The activities of Faculty of Pharmacy of Universidade de Lisboa (FFUL) are coordinated by Bruno Sepodes and Carla Torre from the Systems Integration Pharmacology, Clinical & Regulatory Science Laboratory of the Institute for Drug Research at iMed.Ulisboa.

Work package 1-2 and 5-6; Expertise/capacity: Real-world data analyses/use, Communication and dissemination.

 

IQVIA’s main contribution is the support of DICA with the registry data for More-EUROPA’s case study on lung cancer.

Work package 1-6; Expertise/capacity: HTA/payer medicinal product evaluation, Real-world data analyses/use, Registry owner, Patient engagement, Ethical expertise, Sex and gender analyses, Communication and dissemination.

 

Partner organisation Karolinska Institutet is in the lead of two of More-EUROPA’s case studies, i.e.: studying generalisability of drug effect estimates across different heart failure sub-populations, and evaluating (cost-)effectiveness/safety of ‘off-label’ rituximab in people with multiple sclerosis. The well-established patient registries that will be used for these case studies are respectively the Swedish Heart Failure registry (SwedeHF) and Swedish Multiple Sclerosis registry (SMSreg). Karolinska Institutet is also in the lead of More-EUROPA’s work package 2 “Establishing RWD accessibility and usefulness”.

Work package 1, 3 and 5-6; Expertise/capacity: Real-world data analyses/use, Sex and genderanalyses, Machine learning/artificial intelligenge, Communication and dissemination.

 

Founded in 2008, Quinten is a French pionneer in Data Science and Artificial Intelligence. Mainly active in the health sector, Quinten has been offering technological services and data-driven decision support tools for a decade. Since, it has developed a deep expertise in algorithmic solutions powered by machine learning to leverage real world health data. Based on a unique combination between advanced Real-World data science and integrated disease and care modeling technologies and know-how. More specifically, regarding the main areas Quinten / Quinten Health has extensive experience and know-how in the following areas, Bayesian modelling, Machine Learning, and Natural Language Processing.
Within More-EUROPA, Quinten / Quinten Health works on work package 1 and work package 5-6, and has the lead on work package 3 which is centered on creating a screening tool that can efficiently and effectively identify appropriate registries and Real-World Data in a timely manner.
See also: More-Europa Project | Quinten Health

Work package 1-2 and 5-6; Expertise/capacity: Real-world data analyses/use, Registry owner, Patient engagement, Ethical expertise, Sex and gender analyses, Communication and dissemination.

 

Partner organisation Radboudumc particularly brings in statistical methological expertise to the project and is in the lead of work package 1 “Development of novel analytical tools”.

Work package 1-3 and 5-6; Expertise/capacity: HTA/payer medicinal product evaluation, Real-world data analyses/use, Communication and dissemination.

 

More-EUROPA’s partner organisation Universita Cattolica del Sacro Cuore (UCSC) is involved in work package 1, 2, 3, 5 and 6. UCSC’s activities are coordinated by Entela Xoxi and Rossella Di Bidino.

Work package 1-6; Expertise/capacity: Regulatory medicinal product evaluation, Real-world data analyses/use, Patient engagement, Sex and gender analyses, Communication and dissemination, Projectmanagement.

 

University Medical Center Groningen (UMCG) is the coordinator of the More-EUROPA project, and is in the lead of work package 5 “Dissemination – guideline development, training and implementation (adoption and use)” and work package 6 “Project management”.