Preprint Article Version 1 This version is not peer-reviewed

The FDA and the State of Chronic Diseases: Cardiovascular, Endocrine, Pulmonary, and Renal Diseases

Version 1 : Received: 30 April 2018 / Approved: 3 May 2018 / Online: 3 May 2018 (05:08:44 CEST)

How to cite: Fiuzat, M.; Gray, M.P..; Koppel, G.A.D..; Kowalski, A.; Roy-Chaudhury, P.; Walsh, M.N.; Jones, D.W.; Neptune, E..; Ratner, R.; West, M.; Wong, B.A..; Califf, R. The FDA and the State of Chronic Diseases: Cardiovascular, Endocrine, Pulmonary, and Renal Diseases. Preprints 2018, 2018050050 (doi: 10.20944/preprints201805.0050.v1). Fiuzat, M.; Gray, M.P..; Koppel, G.A.D..; Kowalski, A.; Roy-Chaudhury, P.; Walsh, M.N.; Jones, D.W.; Neptune, E..; Ratner, R.; West, M.; Wong, B.A..; Califf, R. The FDA and the State of Chronic Diseases: Cardiovascular, Endocrine, Pulmonary, and Renal Diseases. Preprints 2018, 2018050050 (doi: 10.20944/preprints201805.0050.v1).

Abstract

Despite needs for new therapies and improvements in existing approaches in cardiovascular, pulmonary, endocrine, and renal disease, investment in these areas is lagging relative to other specialties. This article summarizes a meeting of key stakeholders of U.S. Food and Drug Administration (FDA) officials, representatives from academia, national organizations, and patients and caregivers. The purpose was to identify and discuss high-priority issues, establish areas of common interest, and explore opportunities for collaboration. During the meeting (September 2016), the construct of a “multimorbidity continuum” emerged, in which chronic diseases are understood as their effects on the whole rather than individual organ systems. Cross-disciplinary priorities included: 1) the need to generate greater high-quality evidence at lower cost; 2) the imperative to develop and implement patient-centered approaches to clinical investigations; 3) the importance of trial participation in under-represented populations, particularly with comorbid conditions, and 4) the need for progress in tobacco regulation. Representatives from each therapeutic area reported on their consensus priorities, and FDA representatives discussed the agency’s role in facilitating broader approaches to therapeutic development and evaluation of disease as linked across organ systems rather than in isolation, and emphasized the importance of patient engagement, collaboration and communication across stakeholders.

Subject Areas

chronic diseases; cardiovascular; renal; endocrine; diabetes; therapeutic advances; tobacco

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