ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic.

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. In this report, we highlight challenges, strategies, and solutions around clinical protocol development and regulatory approval to document our experience and propose plans for future similar healthcare emergencies.

Duke Scholars

Author Christopher Lindsell Biostatistics & Bioinformatics, Division of Biostatistics

Author Christina Eleanor Barkauskas Medicine, Pulmonary, Allergy, and Critical Care Medicine