Closing the Gap Between Populations Enrolled in Traditional Randomized Controlled Trials and Patients Encountered in Clinical Practice: The Case of Heart Failure

Author:

Maggioni Aldo P.12ORCID,Andreotti Felicita12ORCID

Affiliation:

1. ANMCO Research Center, Heart Care Foundation, Florence, Italy (A.P.M.).

2. Fondazione Policlinico Universitario A. Gemelli, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy (F.A.).

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

Reference15 articles.

1. what is it and what can it tell us;Sherman RE;N Engl J Med.,2016

2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH Harmonised Tripartite Guideline: Guideline for good clinical practice (E6 [R2]). Accessed June 28 2021. https://database.ich.org/sites/default/files/E6_R2_ Addendum.pdf

3. European Parliament and Council. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC. Accessed June 28 2021. https://ec.europa.eu/health/sites/ default/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf.

4. Participation in a heart failure clinical trial: perspectives and opportunities from the VICTORIA trial and VICTORIA simultaneous registry;Ezekowitz J;Circ Heart Fail.,2021

5. Vericiguat in patients with heart failure and reduced ejection fraction;Armstrong PW;N Engl J Med.,2020

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