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The time is now: role of pragmatic clinical trials in guiding response to global pandemics.
Almufleh, Aws; Joseph, Jacob.
  • Almufleh A; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Joseph J; Department of Medicine, Division of Cardiology, Queen's University, Kingston, Ontario, K7L 2V7, Canada.
Trials ; 22(1): 229, 2021 Mar 24.
Article in English | MEDLINE | ID: covidwho-1150419
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Research Design / Pragmatic Clinical Trials as Topic / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: S13063-021-05165-0

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Research Design / Pragmatic Clinical Trials as Topic / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2021 Document Type: Article Affiliation country: S13063-021-05165-0