Literature DB >> 33761968

The time is now: role of pragmatic clinical trials in guiding response to global pandemics.

Aws Almufleh1,2, Jacob Joseph3,4,5.   

Abstract

Along with its heavy toll of morbidity and mortality, the coronavirus disease 2019 (COVID-19) pandemic exposed several limitations of the current global research response. The slow and inefficient process of carrying out traditional randomized clinical trials led regulatory authorities to hastily approve treatments and tests without sufficient evidence of safety and efficacy.We here outline issues with the current research platform, summarize shortcomings of traditional randomized clinical trials particularly apparent at the time of pandemics, and highlight the advantages of pragmatic clinical trials as an alternative to rapidly generate the needed clinical evidence. We further discuss barriers and challenges to pragmatic clinical trials implementation and explore opportunities for research institutions and regulatory authorities to facilitate widespread adoption of this vital research tool.As a subsequent wave of COVID-19, and/or another epidemic, are all but inevitable in our lifetime, we must ensure that our research infrastructure is conducive to carrying out pragmatic clinical trials to expeditiously generate the needed evidence and blunt the epidemic's toll on human lives and livelihoods.

Entities:  

Keywords:  Adaptive trials design; COVID-19 pandemic; Electronic health records-embedded research; Pragmatic clinical trials

Mesh:

Year:  2021        PMID: 33761968      PMCID: PMC7988242          DOI: 10.1186/s13063-021-05165-0

Source DB:  PubMed          Journal:  Trials        ISSN: 1745-6215            Impact factor:   2.279


  10 in total

1.  What the public think about participation in medical research during an influenza pandemic: an international cross-sectional survey.

Authors:  N Gobat; C C Butler; J Mollison; N A Francis; M Gal; V Harris; S A R Webb; J-P Byrne; A Watkins; P Sukumar; K Hood; A Nichol
Journal:  Public Health       Date:  2019-09-23       Impact factor: 2.427

2.  Explanatory and pragmatic attitudes in therapeutical trials.

Authors:  D Schwartz; J Lellouch
Journal:  J Chronic Dis       Date:  1967-08

3.  The electronic health record as a clinical trials tool: Opportunities and challenges.

Authors:  Monica M Bertagnolli; Brian Anderson; Andre Quina; Steven Piantadosi
Journal:  Clin Trials       Date:  2020-04-08       Impact factor: 2.486

4.  Why do we need some large, simple randomized trials?

Authors:  S Yusuf; R Collins; R Peto
Journal:  Stat Med       Date:  1984 Oct-Dec       Impact factor: 2.373

5.  Exploring the ethical and regulatory issues in pragmatic clinical trials.

Authors:  Robert M Califf; Jeremy Sugarman
Journal:  Clin Trials       Date:  2015-09-15       Impact factor: 2.486

6.  Systematic review of the registered clinical trials for coronavirus disease 2019 (COVID-19).

Authors:  Rui-Fang Zhu; Yu-Lu Gao; Sue-Ho Robert; Jin-Ping Gao; Shi-Gui Yang; Chang-Tai Zhu
Journal:  J Transl Med       Date:  2020-07-06       Impact factor: 5.531

7.  Development and validation of a heart failure with preserved ejection fraction cohort using electronic medical records.

Authors:  Yash R Patel; Jeremy M Robbins; Katherine E Kurgansky; Tasnim Imran; Ariela R Orkaby; Robert R McLean; Yuk-Lam Ho; Kelly Cho; J Michael Gaziano; Luc Djousse; David R Gagnon; Jacob Joseph
Journal:  BMC Cardiovasc Disord       Date:  2018-06-28       Impact factor: 2.298

8.  The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design.

Authors:  Derek C Angus; Scott Berry; Roger J Lewis; Farah Al-Beidh; Yaseen Arabi; Wilma van Bentum-Puijk; Zahra Bhimani; Marc Bonten; Kristine Broglio; Frank Brunkhorst; Allen C Cheng; Jean-Daniel Chiche; Menno De Jong; Michelle Detry; Herman Goossens; Anthony Gordon; Cameron Green; Alisa M Higgins; Sebastiaan J Hullegie; Peter Kruger; Francois Lamontagne; Edward Litton; John Marshall; Anna McGlothlin; Shay McGuinness; Paul Mouncey; Srinivas Murthy; Alistair Nichol; Genevieve K O'Neill; Rachael Parke; Jane Parker; Gernot Rohde; Kathryn Rowan; Anne Turner; Paul Young; Lennie Derde; Colin McArthur; Steven A Webb
Journal:  Ann Am Thorac Soc       Date:  2020-07

9.  Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19.

Authors:  Joshua Geleris; Yifei Sun; Jonathan Platt; Jason Zucker; Matthew Baldwin; George Hripcsak; Angelena Labella; Daniel K Manson; Christine Kubin; R Graham Barr; Magdalena E Sobieszczyk; Neil W Schluger
Journal:  N Engl J Med       Date:  2020-05-07       Impact factor: 91.245

Review 10.  COVID-19 diagnosis and management: a comprehensive review.

Authors:  Giuseppe Pascarella; Alessandro Strumia; Chiara Piliego; Federica Bruno; Romualdo Del Buono; Fabio Costa; Simone Scarlata; Felice Eugenio Agrò
Journal:  J Intern Med       Date:  2020-05-13       Impact factor: 13.068

  10 in total
  4 in total

1.  The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic.

Authors:  Hans H Liu; Michael D Ezekowitz; Michele Columbo; Oneib Khan; Jack Martin; Judith Spahr; David Yaron; Lisa Cushinotto; Luciano Kapelusznik
Journal:  Trials       Date:  2021-09-07       Impact factor: 2.279

Review 2.  Health science research barriers and facilitators in the midst of the COVID-19 crisis: scoping review

Authors:  Karen Daniela Neira-Fernández; Laura Gaitán-Lee; Olga Janneth Gómez-Ramírez
Journal:  Rev Colomb Obstet Ginecol       Date:  2021-12-30

Review 3.  Mapping ongoing nutrition intervention trials in muscle, sarcopenia, and cachexia: a scoping review of future research.

Authors:  Camila E Orsso; Montserrat Montes-Ibarra; Merran Findlay; Barbara S van der Meij; Marian A E de van der Schueren; Francesco Landi; Alessandro Laviano; Carla M Prado
Journal:  J Cachexia Sarcopenia Muscle       Date:  2022-03-17       Impact factor: 12.063

Review 4.  Data capture and sharing in the COVID-19 pandemic: a cause for concern.

Authors:  Louis Dron; Vinusha Kalatharan; Alind Gupta; Jonas Haggstrom; Nevine Zariffa; Andrew D Morris; Paul Arora; Jay Park
Journal:  Lancet Digit Health       Date:  2022-10
  4 in total

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