Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3).
Daniel D MurrayAbdel G BabikerJason V BakerChristina E BarkauskasSamuel M BrownChristina C ChangVictoria J DaveyAnnetine C GelijnsAdit A GindeBirgit GrundElizabeth HiggsFleur HudsonVirginia L KanH Clifford LaneThomas A MurrayRoger ParedesMahesh Kb ParmarSarah PettAndrew N PhillipsMark N PolizzottoCavan ReillyUriel SandkovskyShweta SharmaMarc TeitelbaumB Taylor ThompsonBarnaby E YoungJames D NeatonJens D LundgrenPublished in: Clinical trials (London, England) (2021)
Through a robust multi-network partnership, the Therapeutics for Inpatients with COVID-19 protocol has been successfully used across a global network of sites for rapid generation of efficacy data on multiple novel antiviral agents. The protocol design and implementation features used in this protocol, and the approaches to address challenges, will have broader applicability. Mechanisms to facilitate improved communication and harmonization among country-specific regulatory bodies are required to achieve the full potential of this approach in dealing with a global outbreak.