Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): Designing Master Protocols for Evaluation of...

Area of Science:

• * Public health and infectious disease research
• * Clinical trial design and methodology
• * Pharmaceutical development and therapeutic interventions

Background:

• * The COVID-19 pandemic necessitated rapid development of therapeutic interventions.
• * Existing research networks were leveraged to accelerate study initiation.
• * A portfolio approach was adopted to address diverse patient populations.

Purpose of the Study:

• * To describe the design, development, and launch of 9 master protocols by the ACTIV partnership.
• * To evaluate multiple investigational therapeutic agents for COVID-19 efficiently.
• * To share lessons learned for future pandemic preparedness.

Main Methods:

• * Development of 9 master protocols within an unprecedented timeframe (April 2020–May 2021).
• * Portfolio approach targeting mild to critically ill COVID-19 patients.
• * Utilization of existing research networks and adaptive/pragmatic trial designs.
• * Testing of prioritized agent classes across disease pathophysiology.

Main Results:

• * Successful launch of 9 coordinated master protocols for COVID-19 therapeutics.
• * Efficient evaluation framework designed to identify beneficial treatments and eliminate ineffective/unsafe ones.
• * Covered a spectrum of COVID-19 patient severity, from outpatients to critically ill inpatients.

Conclusions:

• * The ACTIV master protocols demonstrated a rapid and coordinated approach to therapeutic evaluation.
• * Lessons learned from this initiative can inform strategies for future pandemic response.
• * Public-private partnerships are crucial for accelerating medical countermeasures during health crises.