A Systematic Review of Human Challenge Trials, Designs, and Safety.
Jupiter Adams-PhippsDanny ToomeyWitold WięcekVirginia SchmitJames WilkinsonKeller SchollEuzebiusz JamrozikJoshua OsowickiMeta RoestenbergDavid ManheimPublished in: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (2022)
HCTs are increasingly common and used for an expanding list of diseases. Although AEs occur, severe AEs and SAEs are rare. Reporting has improved over time, though not all papers provide a comprehensive report of relevant health impacts. We found very few severe symptoms or SAEs in studies that reported them, but many HCTs did not report relevant safety data. This study was pre-registered on PROSPERO as CRD42021247218.