Large scale clinical trials: lessons from the COVID-19 pandemic.
Alex Robert HorsleyLaurence PearmainSean KnightNick SchindlerRan WangMiriam BennettRebecca C RobeyJane C DaviesRatko DjukanovićLiam G HeaneyTracy HussellStefan John MarciniakLorcan P McGarveyJoanna PorterTom WilkinsonChristopher E BrightlingLing-Pei HoPublished in: BMJ open respiratory research (2022)
Delivery of clinical trials, particularly earlier phase trials, in a pandemic clinical environment is highly challenging, and was reactive rather than anticipatory. Future pandemic studies should be designed and tested in advance, making use of pragmatic study designs as far as possible and planning for integration between early and later phase trials and regulatory frameworks.