Publications by authors named "M A Proschan"

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Cross-Trial Statistics Group gathered lessons learned from statisticians responsible for the design and analysis of the 11 ACTIV therapeutic master protocols to inform contemporary trial design as well as preparation for a future pandemic. The ACTIV master protocols were designed to rapidly assess what treatments might save lives, keep people out of the hospital, and help them feel better faster. Study teams initially worked without knowledge of the natural history of disease and thus without key information for design decisions.

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Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally.

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The first Adaptive COVID-19 Treatment Trial (ACTT-1) showed that remdesivir improved COVID-19 recovery time compared with placebo in hospitalized adults. The secondary outcome of mortality was almost significant overall (p = 0.07) and highly significant for people receiving supplemental oxygen at enrollment (p = 0.

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Article Synopsis
  • In March 2020, the White House Coronavirus Task Force identified the need for expert treatment guidelines for managing COVID-19 due to its life-threatening nature and lack of known effective treatments.
  • The NIH was tasked with quickly assembling a panel of experts to create "living" guidelines, which would be regularly updated as new information about the virus emerged.
  • The article reflects on the Panel's experiences over four years, summarizes its final recommendations, discusses ongoing challenges, and notes that the responsibility for COVID-19 guidelines will now shift to professional organizations following the end of the public health emergency.
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