Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality.
Joseph M UngerHillary StiresLaura A LevitMark D StewartBrittany Avin McKelveyBeverly E CaninEmily DresslerKeith T FlahertyPeter FredetteLee JonesPeggy McCannTherica M MillerAdedayo A OnitiloFran PalmieriTimil PatelRocio PaulGary L SmithSuanna Steeby BruinoogeElizabeth Garrett-MayerXiudong Jennifer LeiAjjai AlvaCaroline SchenkelPublished in: JCO oncology practice (2023)
Despite nearly all sponsors observing a temporary increase in protocol deviations, most reported the pandemic had minimal/no impact on overall data integrity. The COVID-19 pandemic accelerated an emerging trend toward greater flexibility in trial conduct, with potential benefits of reduced burden on trial participants and sites and improved patient access to research.