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

Area of Science:

• Virology
• Clinical Trials
• Public Health

Background:

• The Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) initiative was launched in 2020 to expedite COVID-19 vaccine and therapeutic development.
• The ACTIV Therapeutics-Clinical Working Group focused on creating master protocols for diverse patient populations.
• Clinical trials were designed to inform global COVID-19 treatment strategies across outpatient, inpatient, and intensive care settings.

Purpose of the Study:

• To document the experiences, challenges, and solutions encountered during the clinical protocol development and regulatory approval processes within the ACTIV initiative.
• To propose strategies for future public health emergencies based on lessons learned from the ACTIV program.
• To provide insights into the rapid development and testing of medical countermeasures.

Main Methods:

• Formation of the ACTIV Therapeutics-Clinical Working Group.
• Selection of clinical trial teams and networks for protocol development.
• Design and launch of master protocols tailored to therapeutic targets and patient groups.

Main Results:

• Successfully developed and launched a suite of clinical trials under master protocols.
• Identified key challenges in clinical protocol development and regulatory approval.
• Devised strategies and solutions to overcome these challenges.

Conclusions:

• The ACTIV initiative demonstrated a structured approach to accelerate COVID-19 therapeutic and vaccine development.
• Documented challenges and solutions offer valuable insights for future pandemic preparedness.
• The experience provides a framework for rapid response to emerging healthcare crises.