Literature DB >> 33183511

Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel.

Mitchell A Psotka1, William T Abraham2, Mona Fiuzat3, Gerasimos Filippatos4, JoAnn Lindenfeld5, Tariq Ahmad6, Ankeet S Bhatt7, Peter E Carson8, John G F Cleland9, G Michael Felker10, James L Januzzi11, Dalane W Kitzman12, Eric S Leifer13, Eldrin F Lewis14, John J V McMurray15, Robert J Mentz10, Scott D Solomon7, Norman Stockbridge16, John R Teerlink17, Muthiah Vaduganathan7, Orly Vardeny18, David J Whellan19, Janet Wittes20, Stefan D Anker21, Christopher M O'Connor22.   

Abstract

The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members. A series of meetings were convened to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish key recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure. This paper summarizes the discussions and expert consensus recommendations.
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  COVID-19; clinical trial; endpoint ascertainment; heart failure

Mesh:

Year:  2020        PMID: 33183511     DOI: 10.1016/j.jacc.2020.09.544

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


  10 in total

1.  A Comparative NLP-Based Study on the Current Trends and Future Directions in COVID-19 Research.

Authors:  Priyankar Bose; Satyaki Roy; Preetam Ghosh
Journal:  IEEE Access       Date:  2021-05-20       Impact factor: 3.367

2.  Challenges of Conducting Clinical Trials during the SARS-CoV-2 Pandemic: The ASCEND Global Program Experience.

Authors:  Kirsten L Johansen; Anjali Acharya; Borut Cizman; Alexander R Cobitz; Ricardo Correa-Rotter; Indranil Dasgupta; Vijay Kher; Renato D Lopes; Leonardo Matsumoto; Amy M Meadowcroft; Osvaldo Merege Vieira Neto; Marilu Okabe; Brian Rayner; Arnold Silva; Hilary Thomas; Ajay K Singh
Journal:  Kidney360       Date:  2022-02-10

3.  'Tracking Together'-Simultaneous Use of Human and Dog Activity Trackers: Protocol for a Factorial, Randomized Controlled Pilot Trial.

Authors:  Wasantha Jayawardene; Lesa Huber; Jimmy McDonnell; Laurel Curran; Sarah Larson; Stephanie Dickinson; Xiwei Chen; Erika Pena; Aletha Carson; Jeanne Johnston
Journal:  Int J Environ Res Public Health       Date:  2021-02-07       Impact factor: 3.390

Review 4.  The impact of COVID-19 on the cell and gene therapies industry: disruptions, opportunities, and future prospects.

Authors:  Tingting Qiu; Yitong Wang; Shuyao Liang; Ru Han; Mondher Toumi
Journal:  Drug Discov Today       Date:  2021-04-20       Impact factor: 7.851

5.  Update on RFA Increasing Use of Cardiac and Pulmonary Rehabilitation in Traditional and Community Settings NIH-Funded Trials: ADDRESSING CLINICAL TRIAL CHALLENGES PRESENTED BY THE COVID-19 PANDEMIC.

Authors:  Susan T Shero; Roberto Benzo; Lawton S Cooper; Joseph Finkelstein; Daniel E Forman; Diann E Gaalema; Lyndon Joseph; Steven J Keteyian; Pamela N Peterson; Antonello Punturieri; Susan Zieman; Jerome L Fleg
Journal:  J Cardiopulm Rehabil Prev       Date:  2022-01-01       Impact factor: 3.646

6.  One-year follow up of vascular intervention trials disrupted by the COVID-19 pandemic: A use-case landscape.

Authors:  Jennifer A Rymer; Ajay J Kirtane; Andrew Farb; Misti Malone; Michael R Jaff; Kirk Seward; Dan Stephens; Mark R Barakat; Mitchell W Krucoff
Journal:  Cardiovasc Revasc Med       Date:  2022-07-26

Review 7.  Direct mechanisms of SARS-CoV-2-induced cardiomyocyte damage: an update.

Authors:  Yicheng Yang; Zhiyao Wei; Changming Xiong; Haiyan Qian
Journal:  Virol J       Date:  2022-06-25       Impact factor: 5.913

8.  Rethinking informed consent in the time of COVID-19: An exploratory survey.

Authors:  Evelien De Sutter; Teodora Lalova-Spinks; Pascal Borry; Peggy Valcke; Els Kindt; Anastassia Negrouk; Griet Verhenneman; Jean-Jacques Derèze; Ruth Storme; Isabelle Huys
Journal:  Front Med (Lausanne)       Date:  2022-09-27

9.  Clinical research during the COVID-19 pandemic: The role of virtual visits and digital approaches.

Authors:  Tammy L Loucks; Clare Tyson; David Dorr; Vesna D Garovic; James Hill; S David McSwain; Sally Radovick; Frank A Sonnenberg; Jennifer A Weis; Kathleen T Brady
Journal:  J Clin Transl Sci       Date:  2021-03-08

10.  Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E'jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial.

Authors:  Zhuo Song; Ling-Yun Sun; Shan-Shan Gu; Xiao-Shu Zhu; He-Zheng Lai; Fang Lu; Ning Cui; Qiong-Yang Li; Yu Wu; Yun Xu
Journal:  Integr Cancer Ther       Date:  2021 Jan-Dec       Impact factor: 3.279

  10 in total

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