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

Fingerprint

Heart Failure
Education
Biomedical Technology Assessment
Delivery of Health Care
Costs and Cost Analysis
Health
Therapeutics
Patient Reported Outcome Measures

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Pani, L., Pecorelli, S., Rosano, G., Anker, S. D., Peracino, A., Fregonese, L., ... 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

Steps forward in regulatory pathways for acute and chronic heart failure. / Pani, Luca; Pecorelli, Sergio; Rosano, Giuseppe; Anker, Stefan D.; Peracino, Andrea; Fregonese, Laura; Prasad, Krishna; Rasi, Guido.

In: European Journal of Heart Failure, Vol. 17, No. 1, 01.01.2015, p. 3-8.

Research output: Contribution to journalArticle

Pani, L, Pecorelli, S, Rosano, G, Anker, SD, 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, vol. 17, no. 1, pp. 3-8. https://doi.org/10.1002/ejhf.209
Pani, Luca ; Pecorelli, Sergio ; Rosano, Giuseppe ; Anker, Stefan D. ; Peracino, Andrea ; Fregonese, Laura ; Prasad, Krishna ; Rasi, Guido. / Steps forward in regulatory pathways for acute and chronic heart failure. In: European Journal of Heart Failure. 2015 ; Vol. 17, No. 1. pp. 3-8.
@article{b174ff60815044a198dd88cc54b8603e,
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.",
keywords = "Clinical trial design, Health technology assessment, Heart failure, Regulatory science",
author = "Luca Pani and Sergio Pecorelli and Giuseppe Rosano and Anker, {Stefan D.} and Andrea Peracino and Laura Fregonese and Krishna Prasad and Guido Rasi",
year = "2015",
month = "1",
day = "1",
doi = "10.1002/ejhf.209",
language = "English",
volume = "17",
pages = "3--8",
journal = "European Journal of Heart Failure",
issn = "1388-9842",
publisher = "John Wiley & Sons, Ltd",
number = "1",

}

TY - JOUR

T1 - Steps forward in regulatory pathways for acute and chronic heart failure

AU - Pani, Luca

AU - Pecorelli, Sergio

AU - Rosano, Giuseppe

AU - Anker, Stefan D.

AU - Peracino, Andrea

AU - Fregonese, Laura

AU - Prasad, Krishna

AU - Rasi, Guido

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.

AB - 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.

KW - Clinical trial design

KW - Health technology assessment

KW - Heart failure

KW - Regulatory science

UR - http://www.scopus.com/inward/record.url?scp=84921341104&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84921341104&partnerID=8YFLogxK

U2 - 10.1002/ejhf.209

DO - 10.1002/ejhf.209

M3 - Article

C2 - 25597869

AN - SCOPUS:84921341104

VL - 17

SP - 3

EP - 8

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

SN - 1388-9842

IS - 1

ER -