title: Steps forward in regulatory pathways for acute and chronic heart failure.
abstract: A workshop was organized by the Agenzia Italiana del Farmaco (AIFA) to discuss unmet needs and ways forward in the development of medicines in heart failure, their rationale, and cost-effective use. An integrated, multidisciplinary approach, including patients' needs and perspectives, was advocated by all the participants as the way to the most effective treatment regimens. More work is needed for reaching consensus on clinical and functional endpoints, for validating patient reported outcomes and measurements of well-being. Similarly, the integration into the clinical programmes of the health technology assessment/payers perspective, in particular, the evaluation of 'real-life' treatment effectiveness and of health as a value, would help in shifting the development and authorization of medicines from the molecule paradigm to their evaluation in the context of the whole health care regimen. Through this kind of workshop, AIFA is trying to build a template for meetings devoted to debate unmet needs with all stakeholders towards tentative road maps for the future.
authors.affiliation: Italian Medicines Agency-AIFA, Rome, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Pani
authors.forename: Sergio
authors.initials: S
authors.lastname: Pecorelli
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rosano
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
authors.forename: Andrea
authors.initials: A
authors.lastname: Peracino
authors.forename: Laura
authors.initials: L
authors.lastname: Fregonese
authors.forename: Krishna
authors.initials: K
authors.lastname: Prasad
authors.forename: Guido
authors.initials: G
authors.lastname: Rasi
mesh_terms: D000208:Acute Disease; D002317:Cardiovascular Agents / Q000191:economics / Q000627:therapeutic use*; D002908:Chronic Disease; D003362:Cost-Benefit Analysis; D055808:Drug Discovery; D004335:Drug and Narcotic Control; D006333:Heart Failure / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D020380:Needs Assessment; D010347:Patient Care Planning; D063868:Patient Outcome Assessment; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents
keywords: Clinical trial design; Health technology assessment; Heart failure; Regulatory science