Steps forward in regulatory pathways for acute and chronic heart failure

Luca Pani, Sergio Pecorelli, Giuseppe Rosano, Stefan D. Anker, Andrea Peracino, Laura Fregonese, Krishna Prasad, Guido Rasi

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)3-8
Number of pages6
JournalEuropean Journal of Heart Failure
Volume17
Issue number1
DOIs
Publication statusPublished - Jan 1 2015

Keywords

  • Clinical trial design
  • Health technology assessment
  • Heart failure
  • Regulatory science

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

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    Pani, L., Pecorelli, S., Rosano, G., Anker, S. D., Peracino, A., Fregonese, L., Prasad, K., & Rasi, G. (2015). Steps forward in regulatory pathways for acute and chronic heart failure. European Journal of Heart Failure, 17(1), 3-8. https://doi.org/10.1002/ejhf.209