The Ageing of the population is an emerging and seemingly irrevocable trend, not only in Europe, but also in the US, Japan and China. The number of Europeans aged 65+ will almost double over the next 50 years, from 85 million in 2008 to 151 million in 2060, and the fastest growing segment is represented by the old-old (75-85 years old) and older old (85+) subjects.
This demographic transition constitutes a real challenge for public authorities, policy makers, healthcare providers and payers, as it will increase the demand of healthcare products and services.
Healthcare Model Optimization
The healthcare infrastructure has been developed around the management of acute disorders or acute complications of chronic disorders. The immediate effect of the increase in life span is the emergence of a segment of the population suffering from simultaneous, multiple chronic conditions, with increasing incapacity, loss of autonomy and negative outcome (falls, institutionalisation and death).
Optimal use of resources becomes a critical issue, as there is today no efficient model of care for this type of conditions, contributing to raising costs and inappropriate use of resources. Very early identification of the risk factors for development of these multimorbid states (the geriatric syndromes), long before they give rise to their negative outcomes and the development of multi-modal intervention to tackle them, is of paramount importance to contain healthcare costs and optimally use scarce ressources.
European Commission Project
The existence of regulatory gaps hampering innovative development in geriatric medicine has been acknowledged in the frame of the European Innovative Partnership on Active & Healthy Aging pilot project launched by the European Commission in 2011.
Up to date Regulatory Authorities drew Industry’s attention to the scarcity of clinical efficacy and safety data obtained in geriatric subgroups, and questioned the acceptability of extrapolating data obtained on approved medicines in younger adults to the general, older population.
Meanwhile no regulatory guidance and scarce regulatory discussion are providing insight on how to develop new medicines for conditions specific to older people, like sarcopenia in the context of physical frailty.
For example, fighting sarcopenia, thereby improving muscle function, should translate in a decrease of major associated outcomes like falls and fractures.
This project will give us the opportunity with Regulators, Academia and other stakeholders, to agree on the therapeutic indication, endpoints and Clinical Trial methodology which will allow to develop innovative treatments for this currently underdiagnosed geriatric condition.
This will be the first non competitive interventional European clinical trial in frail sarcopenic older patients using physical activity as benchmark for future studies with investigational drugs.
The five-year project is the result of a rich multiple collaboration between sixteen major research institutions in the geriatric field across Europe:
Università Cattolica del Sacro Cuore(lead), Le Centre Hospitalier Universitaire de Toulouse, Univerzita Karlova v Praze, Helsingin yliopisto, Servicio Madrileno de Salud , Universitaetsmedizin Goettingen, Georg-August-Universitaet - Stiftung Oeffentlichen Rechts , Université Paris Descartes , Università degli Studi di Firenze , Friedrich- Alexander- Universität Erlangen-Nürnberg , Uniwersytet Jagiellonski , Istituto Nazionale di Riposo e Cura per Anziani-INRCA ; small medium size companies: Caretek s.r.l., EU-Open S.R.l, Roessingh Research and Development ; and five EFPIA members: Sanofi(lead), GSK, Novartis, Servier and Lilly.
What are the Objectives of this project?
To validate an interventional paradigm for identifying at-risk individuals living in the community and evaluate innovative therapeutic interventions against physical frailty and mobility disability, through:
- Creating an operational definition of at-risk (sub-)populations with undisputable unmet therapeutic need
- Qualification of muscular anabolism and catabolism biomarkers in at-risk (sub-) populations
- Validation and implementation of practical clinical methodologies for testing clinically meaningful interventions for the screening, prevention of Physical Frailty and Sarcopenia and its complications (falls, mobility disability, hospitalization, institutionalization)
- Developing scientific and regulatory Consensus on these 3 strategic objectives: therapeutic indication, biomarkers and development clinical methodology
- Developing a health-economic model of physical Frailty and Sarcopenia in a real life setting