2022
DOI: 10.1038/s41591-021-01617-x
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Clinical trial design during and beyond the pandemic: the I-SPY COVID trial

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Cited by 19 publications
(5 citation statements)
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“…This secondary analysis used de-identified data from the I-SPY COVID clinical trial (ClinicalTrials.gov identifier: NCT04488081), for which detailed design and methods have been published previously ( 8 , 9 ). The trial was overseen by a central institutional review board (IRB) at the Wake Forest School of Medicine (IRB00066805, “I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients,” approved on July 9, 2020).…”
Section: Methodsmentioning
confidence: 99%
“…This secondary analysis used de-identified data from the I-SPY COVID clinical trial (ClinicalTrials.gov identifier: NCT04488081), for which detailed design and methods have been published previously ( 8 , 9 ). The trial was overseen by a central institutional review board (IRB) at the Wake Forest School of Medicine (IRB00066805, “I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients,” approved on July 9, 2020).…”
Section: Methodsmentioning
confidence: 99%
“…Carolyn Calfee (San Francisco, CA, USA) introduced adaptive trials (trials with pre-planned capabilities to adjust design factors) as a proposal to deal with the ARDS phenotype heterogeneity, the stratified randomisation and a response adaptation [ 37 39 ]. They had a considerable impact during COVID-19: for example, RECOVERY evaluated 10 treatments in 47 879 participants in 199 sites, and I-SPY-COVID is an adaptive platform for a phase 2 clinical trial to identify agents with potential therapeutic benefit [ 40 , 41 ].…”
Section: Beyond Covid-19: Translating Covid-19 Treatment Successes To...mentioning
confidence: 99%
“…A fifth ad-RCT, the I-SPY Covid Trial [10] , is built on the experience investigators gained in a previous ad-RCT on breast cancer. This trial is a unique collaborative effort by a consortium that included the US FDA, industry, patient advocates, philanthropic sponsors, and clinicians from major US medical research centers [11] .…”
mentioning
confidence: 99%
“…This trial is a unique collaborative effort by a consortium that included the US FDA, industry, patient advocates, philanthropic sponsors, and clinicians from major US medical research centers [11] . Unlike the other ad-RCTs mentioned above, which are phase 3 RCTs, it is a phase 2 trial for rapidly screening and triaging potential treatments [10] . The I-SPY Covid Trial, which started in July 2020, evaluates in parallel up to four (repurposed and novel) medications vs a control (remdesivir; dexamethasone was added later) on top of the standard care for severe COVID-19 patients.…”
mentioning
confidence: 99%
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