Literature DB >> 28838647

From Nonclinical Research to Clinical Trials and Patient-registries: Challenges and Opportunities in Biomedical Research.

José M de la Torre Hernández1, Elazer R Edelman2.   

Abstract

The most important challenge faced by human beings is health. The only way to provide better solutions for health care is innovation, true innovation. The only source of true innovation is research, good research indeed. The pathway from a basic science study to a randomized clinical trial is long and not free of bumps and even landmines. These are all the obstacles and barriers that limit the availability of resources, entangle administrative-regulatory processes, and restrain investigators' initiatives. There is increasing demand for evidence to guide clinical practice but, paradoxically, biomedical research has become increasingly complex, expensive, and difficult to integrate into clinical care with increased barriers to performing the practical aspects of investigation. We face the challenge of increasing the volume of biomedical research and simultaneously improving the efficiency and output of this research. In this article, we review the main stages and methods of biomedical research, from nonclinical studies with animal and computational models to randomized trials and clinical registries, focusing on their limitations and challenges, but also providing alternative solutions to overcome them. Fortunately, challenges are always opportunities in disguise.
Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Entities:  

Keywords:  Biomedical research; Clinical registry; Ensayo clínico aleatorizado; Investigación biomédica; Randomized clinical trial; Registro clínico

Mesh:

Year:  2017        PMID: 28838647      PMCID: PMC5975372          DOI: 10.1016/j.rec.2017.07.008

Source DB:  PubMed          Journal:  Rev Esp Cardiol (Engl Ed)        ISSN: 1885-5857


  79 in total

1.  Uneasy alliance--clinical investigators and the pharmaceutical industry.

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2.  Drugs and operations. Some important differences.

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Journal:  JAMA       Date:  1975-04-07       Impact factor: 56.272

3.  The American Heart Association's recommendations for expanding the applications of existing and future clinical registries: a policy statement from the American Heart Association.

Authors:  Vincent J Bufalino; Frederick A Masoudi; Steven K Stranne; Katie Horton; Nancy M Albert; Craig Beam; Robert O Bonow; Roger L Vern Davenport; Meighan Girgus; Gregg C Fonarow; Harlan M Krumholz; Mark W Legnini; William R Lewis; Graham Nichol; Eric D Peterson; John S Rumsfeld; Lee H Schwamm; David M Shahian; John A Spertus; Pamela K Woodard; Clyde W Yancy
Journal:  Circulation       Date:  2011-04-11       Impact factor: 29.690

4.  Full coverage for preventive medications after myocardial infarction.

Authors:  Niteesh K Choudhry; Jerry Avorn; Robert J Glynn; Elliott M Antman; Sebastian Schneeweiss; Michele Toscano; Lonny Reisman; Joaquim Fernandes; Claire Spettell; Joy L Lee; Raisa Levin; Troyen Brennan; William H Shrank
Journal:  N Engl J Med       Date:  2011-11-14       Impact factor: 91.245

Review 5.  Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project.

Authors:  H Vernon Anderson; William S Weintraub; Martha J Radford; Mark S Kremers; Matthew T Roe; Richard E Shaw; Dana M Pinchotti; James E Tcheng
Journal:  J Am Coll Cardiol       Date:  2013-03-06       Impact factor: 24.094

6.  Drug-eluting stent thrombosis: results from the multicenter Spanish registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos).

Authors:  José M de la Torre-Hernández; Fernando Alfonso; Felipe Hernández; Jaime Elizaga; Marcelo Sanmartin; Eduardo Pinar; Iñigo Lozano; Jose M Vazquez; Javier Botas; Armando Perez de Prado; Jose M Hernández; Juan Sanchis; Juan M Ruiz Nodar; Alfredo Gomez-Jaume; Mariano Larman; Jose A Diarte; Javier Rodríguez-Collado; Jose R Rumoroso; Jose R Lopez-Minguez; Josepa Mauri
Journal:  J Am Coll Cardiol       Date:  2008-03-11       Impact factor: 24.094

Review 7.  Hormone replacement therapy: a useful tool in the prevention of coronary artery disease in postmenopausal women? Working Group on Women and Cardiovascular Disease of The Netherlands Heart Foundation.

Authors:  C J Moerman; J C Witteman; H J Collette; J A Gevers Leuven; C Kluft; P Kenemans; K Meeter
Journal:  Eur Heart J       Date:  1996-05       Impact factor: 29.983

8.  The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART).

Authors:  Tomas Jernberg; Mona F Attebring; Kristina Hambraeus; Torbjorn Ivert; Stefan James; Anders Jeppsson; Bo Lagerqvist; Bertil Lindahl; Ulf Stenestrand; Lars Wallentin
Journal:  Heart       Date:  2010-08-27       Impact factor: 5.994

9.  Comparison of Approaches for Heart Failure Case Identification From Electronic Health Record Data.

Authors:  Saul Blecker; Stuart D Katz; Leora I Horwitz; Gilad Kuperman; Hannah Park; Alex Gold; David Sontag
Journal:  JAMA Cardiol       Date:  2016-12-01       Impact factor: 14.676

10.  Pragmatic Trials.

Authors:  Ian Ford; John Norrie
Journal:  N Engl J Med       Date:  2016-08-04       Impact factor: 91.245

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  2 in total

1.  International pediatric thrombosis network to advance pediatric thrombosis research: Communication from the ISTH SSC subcommittee on pediatric and neonatal thrombosis and hemostasis.

Authors:  C Heleen van Ommen; Manuela Albisetti; Mohir Bhatt; Marianne Bonduel; Brian Branchford; Elizabeth Chalmers; Anthony Chan; Neil A Goldenberg; Susanne Holzhauer; Paul Monagle; Ulrike Nowak-Göttl; Shoshana Revel-Vilk; Gabriela Sciuccatie; Nongnuch Sirachainan; Christoph Male
Journal:  J Thromb Haemost       Date:  2021-04       Impact factor: 5.824

2.  Causal Relationship Between Parathyroid Hormone and the Risk of Osteoarthritis: A Mendelian Randomization Study.

Authors:  Guiwu Huang; Yanlin Zhong; Wenchang Li; Weiming Liao; Peihui Wu
Journal:  Front Genet       Date:  2021-07-26       Impact factor: 4.599

  2 in total

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