About
COVID-19 showed the importance of fast and effective ways to study potential treatments. Traditional randomized controlled trials (RCT), while often methodologically robust, face challenges such as inflexibility, extended durations, and high costs.
Master protocols, including adaptive platform trials (APTs), present a promising alternative capable of accelerating a research response to emerging health threats. APTs allow researchers to test multiple treatments at the same time without needing to start additional trials when new evidence becomes available. Researchers can add or drop treatments over the course of the APT, saving time and costs compared to traditional methods. During the COVID-19 pandemic, APTs have been crucial in identifying potential treatments for COVID-19 in both outpatient and inpatient settings.
In this study, we will evaluate three COVID-19 APTs—TOGETHER, PANORAMIC, and REMAP-CAP—to develop guidelines for setting up APTs more efficiently for other diseases or future pandemics.
In part 1, we aim to examine how these trials, rooted in different clinical settings (outpatient and inpatient), have navigated the design, operation, and outcomes amidst the pandemic’s challenges. We will focus on the innovative methodologies they employed, and the various success metrics and challenges they encountered. We will conduct a multiple case study analysis of the three APTs, with each APT conceptualized as a “case”. Data will be analyzed and interpreted at the case level as well as across cases in order to highlight meaningful similarities, differences, and study-specific experiences.
In part 2, we will use the findings from Part 1 (key challenges and solutions, as well as key opportunities and lessons learned) to develop relevant logistical guidelines to support the creation of APTs for other conditions and future pandemics. We will engage a broad set of stakeholders in the guideline development process. These guidelines offer a structured roadmap for establishing and operating APTs more efficiently.
Impact
Aligned with CIHR’s dedication to innovation in health research, our study aims to enhance Canada’s readiness for future health emergencies. By establishing a focus on the logistical innovation offered by APTs, we can importantly reduce the time between a health threat’s emergence and our clinical research response, improving patient engagement, outcomes and system efficiency.