Literature DB >> 27765193

The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease.

W Schuyler Jones1, Matthew T Roe2, Elliott M Antman3, Mark J Pletcher4, Robert A Harrington5, Russell L Rothman6, William J Oetgen7, Sunil V Rao2, Mitchell W Krucoff2, Lesley H Curtis2, Adrian F Hernandez2, Frederick A Masoudi8.   

Abstract

Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements. This review will examine the current landscape of cardiovascular clinical trials in the United States, highlight recently conducted registry-based clinical trials, and discuss the potential attributes of the recently launched pragmatic clinical trial by the Patient-Centered Outcomes Research Institute's National Patient-Centered Clinical Research Network, called the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing the Benefits and Long-term Effectiveness) trial.
Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Patient-Centered Outcomes Research Institute; aspirin; coronary artery disease; pragmatic clinical trial

Mesh:

Year:  2016        PMID: 27765193     DOI: 10.1016/j.jacc.2016.07.781

Source DB:  PubMed          Journal:  J Am Coll Cardiol        ISSN: 0735-1097            Impact factor:   24.094


  23 in total

1.  An Observational Study of the Association of Video- Versus Text-Based Informed Consent With Multicenter Trial Enrollment: Lessons From the PALM Study (Patient and Provider Assessment of Lipid Management).

Authors:  Alexander C Fanaroff; Shuang Li; Laura E Webb; Vincent Miller; Ann Marie Navar; Eric D Peterson; Tracy Y Wang
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2018-04

2.  Days Alive and Out of Hospital: Exploring a Patient-Centered, Pragmatic Outcome in a Clinical Trial of Patients With Acute Coronary Syndromes.

Authors:  Alexander C Fanaroff; Derek Cyr; Megan L Neely; Jeffery Bakal; Harvey D White; Keith A A Fox; Paul W Armstrong; Renato D Lopes; E Magnus Ohman; Matthew T Roe
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2018-12

3.  Real-World Evidence: Promise and Peril For Medical Product Evaluation.

Authors:  Sanket S Dhruva; Joseph S Ross; Nihar R Desai
Journal:  P T       Date:  2018-08

Review 4.  Effect of renin-angiotensin system inhibitors on mortality in heart failure with preserved ejection fraction: a meta-analysis of observational cohort and randomized controlled studies.

Authors:  Hidekatsu Fukuta; Toshihiko Goto; Kazuaki Wakami; Nobuyuki Ohte
Journal:  Heart Fail Rev       Date:  2017-11       Impact factor: 4.214

Review 5.  From Nonclinical Research to Clinical Trials and Patient-registries: Challenges and Opportunities in Biomedical Research.

Authors:  José M de la Torre Hernández; Elazer R Edelman
Journal:  Rev Esp Cardiol (Engl Ed)       Date:  2017-08-31

Review 6.  Antithrombotic agents for secondary prevention after acute coronary syndromes: A systematic review and network meta-analysis.

Authors:  Alexander C Fanaroff; Vic Hasselblad; Matthew T Roe; Deepak L Bhatt; Stefan K James; Ph Gabriel Steg; C Michael Gibson; E Magnus Ohman
Journal:  Int J Cardiol       Date:  2017-03-14       Impact factor: 4.164

7.  Exploring Understanding of "Understanding": The Paradigm Case of Biobank Consent Comprehension.

Authors:  Laura M Beskow; Kevin P Weinfurt
Journal:  Am J Bioeth       Date:  2019-05       Impact factor: 11.229

8.  Computable Phenotype Implementation for a National, Multicenter Pragmatic Clinical Trial: Lessons Learned From ADAPTABLE.

Authors:  Faraz S Ahmad; Iben M Ricket; Bradley G Hammill; Lisa Eskenazi; Holly R Robertson; Lesley H Curtis; Cecilia D Dobi; Saket Girotra; Kevin Haynes; Jorge R Kizer; Sunil Kripalani; Mathew T Roe; Christianne L Roumie; Russ Waitman; W Schuyler Jones; Mark G Weiner
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2020-05-29

9.  Lessons learned in the use of clinical registry data in a multi-centre prospective study: the Pediatric Heart Network Residual Lesion Score Study.

Authors:  Carol J Prospero; Felicia L Trachtenberg; Victoria L Pemberton; Sara K Pasquali; Brett R Anderson; Kathleen E Ash; Jessica Bainton; Carolyn Dunbar-Masterson; Eric M Graham; Michelle S Hamstra; Danielle Hollenbeck-Pringle; Jeffrey P Jacobs; Marshall L Jacobs; Rija John; Linda M Lambert; Matthew E Oster; Elizabeth Swan; Abigail Waldron; Meena Nathan
Journal:  Cardiol Young       Date:  2019-06-17       Impact factor: 1.093

10.  Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

Authors:  Robert Fleischmann; Anne-Marie Decker; Antje Kraft; Knut Mai; Sein Schmidt
Journal:  BMC Med Res Methodol       Date:  2017-12-01       Impact factor: 4.615

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