R. Le Lain, C. Ignaszewski, I. Klingmann, A. Cesario, W.I. de Boer, for the SPRINTT Consortium
Aging Clin Exp Res Epub 2017 Feb 10
CLICK HERE TO READ THE FULL TEXT
The current healthcare systems are built around the traditional paradigm of patients suffering from a single acute illness. They are, therefore, largely unprepared to face the increasing demands for health services arising from the expansion of an older population with specific medical needs related to multiple chronic disorders. As a consequence, the medical conditions of a large and growing segment of the older European population are not efficiently managed by the available healthcare services. In the context of an aging population, policy makers such as the European Commission and European Institutions, such as the European Medicines Agency (EMA), devote time and resources to study and accompany the need of the aging population. The EMA recognizes the importance of making sure that the needs of the Elderly are considered during development, approval, and use of new medicines, and, therefore, engages with healthcare professional organisations. The Sarcopenia and Physical Frailty in Older People: Multicomponent Intervention Strategies (SPRINTT) is the obvious result of these strategies. The present article describes the SPRINTT workpackage activities aimed at engaging the scientific discussion on the physical frailty and sarcopenia with the EMA as one of its interlocutor acknowledging the need to collaborate on this topic to foster a productive dialogue.
Comment: The early dialogue with regulators and, based on of the outcome of the SPRINTT trial, the possible validation of some key criteria for the study of PF&S, will pave the way for future therapeutic development in this geriatric indication, an area of unmet societal need. In addition, the continuous advisory involvement of stakeholders ensures that the project, its execution, and outcomes are adapted to or meet the needs of the (end) users including patients and healthcare providers and regulatory authorities to enable the early diagnosis and to quicken the development of new treatments for this aging population.