Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?

Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?

Given the high case fatality rate of SARS-CoV-2, for which there is no cure and no vaccine, clinicians are forced to make decisions about how best to manage patients with limited high-quality evidence to guide treatment. Traditional randomized controlled trials provide strong experimental evidence,...

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Main Authors: Westyn Branch-Elliman, Lisa Soleymani Lehmann, William E. Boden, Ryan Ferguson, Paul Monach
Format: Article
Language:English
Published: Elsevier 2020-09-01
Series:Contemporary Clinical Trials Communications
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865420300983
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spelling doaj-3548f67f8d734a61bb89502e8b48ad832020-11-25T04:04:29ZengElsevierContemporary Clinical Trials Communications2451-86542020-09-0119100614Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?Westyn Branch-Elliman0Lisa Soleymani Lehmann1William E. Boden2Ryan Ferguson3Paul Monach4VA Boston Healthcare System, Department of Medicine, Boston, MA, USA; VA Boston Center for Healthcare Organization and Implementation Research (CHOIR), Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Corresponding author. VA Boston Healthcare System, Department of Medicine, Boston, MA, USA.VA Boston Healthcare System, Department of Medicine, Boston, MA, USA; VA Boston Center for Healthcare Organization and Implementation Research (CHOIR), Boston, MA, USA; Harvard Medical School, Boston, MA, USAVA Boston Healthcare System, Department of Medicine, Boston, MA, USA; Boston University School of Medicine, Boston, MA, USABoston University School of Medicine, Boston, MA, USA; Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), Boston, MA, USA; Boston University School of Public Health, Boston, MA, USAVA Boston Healthcare System, Department of Medicine, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Division of Rheumatology Inflammation and Immunity, Brigham and Women's Hospital, USAGiven the high case fatality rate of SARS-CoV-2, for which there is no cure and no vaccine, clinicians are forced to make decisions about how best to manage patients with limited high-quality evidence to guide treatment. Traditional randomized controlled trials provide strong experimental evidence, however, tend to be slow, inflexible, and have limited generalizability. Adaptive and pragmatic designs are an attractive alternative, which meet our ethical obligation during the SARS-CoV-2 pandemic to balance speed, agility, and generalizability with both prospective study and scientific rigor.http://www.sciencedirect.com/science/article/pii/S2451865420300983
collection DOAJ
language English
format Article
sources DOAJ
author Westyn Branch-Elliman
Lisa Soleymani Lehmann
William E. Boden
Ryan Ferguson
Paul Monach
spellingShingle Westyn Branch-Elliman
Lisa Soleymani Lehmann
William E. Boden
Ryan Ferguson
Paul Monach
Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?
Contemporary Clinical Trials Communications
author_facet Westyn Branch-Elliman
Lisa Soleymani Lehmann
William E. Boden
Ryan Ferguson
Paul Monach
author_sort Westyn Branch-Elliman
title Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?
title_short Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?
title_full Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?
title_fullStr Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?
title_full_unstemmed Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?
title_sort pragmatic, adaptive clinical trials: is 2020 the dawning of a new age?
publisher Elsevier
series Contemporary Clinical Trials Communications
issn 2451-8654
publishDate 2020-09-01
description Given the high case fatality rate of SARS-CoV-2, for which there is no cure and no vaccine, clinicians are forced to make decisions about how best to manage patients with limited high-quality evidence to guide treatment. Traditional randomized controlled trials provide strong experimental evidence, however, tend to be slow, inflexible, and have limited generalizability. Adaptive and pragmatic designs are an attractive alternative, which meet our ethical obligation during the SARS-CoV-2 pandemic to balance speed, agility, and generalizability with both prospective study and scientific rigor.
url http://www.sciencedirect.com/science/article/pii/S2451865420300983
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AT ryanferguson pragmaticadaptiveclinicaltrialsis2020thedawningofanewage
AT paulmonach pragmaticadaptiveclinicaltrialsis2020thedawningofanewage
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