Resilient clinical trial infrastructure in response to the COVID-19 pandemic: Lessons learned from the TOGETHER randomized platform clinical trial

In 2020, clinical trial researchers developed protocols to evaluate the safety and effectiveness of potential treatments for COVID-19. Despite more than 3,000 trials registered , few have generated findings, with the exception of smaller randomized controlled trials.A clinical trial infrastructure (defined as the human, material, and knowledge networks that form a responsive implementation of productive trial protocols) must be resilient to threats (e.g., COVID-19), and is essential when barriers to sustainable funding are common.
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Abstract

In response to the COVID-19 pandemic, clinical research groups across the world developed trial protocols to evaluate the safety and efficacy of treatments for COVID-19. Despite this initial enthusiasm, only a small portion of these protocols were implemented. Of those implemented, a fraction successfully recruited their target sample size to analyze and disseminate findings. More than a year and a half into the COVID-19 pandemic, only a few clinical trials evaluating treatments for COVID-19 have generated new evidence. Productive randomized platform clinical trials evaluating COVID-19 treatments may attribute their success to intentional investments in developing resilient clinical trial infrastructures. Health system resiliency discourse provides a conceptual framework for characterizing attributes for withstanding shocks. This framework may also be useful for contextualizing the attributes of productive clinical trials evaluating COVID-19 therapies. We characterize the successful attributes and lessons learned in developing the TOGETHER Trial infrastructure using a health system resiliency framework. This framework may be considered by clinical trialists aiming to build resilient trial infrastructures capable of responding rapidly and efficiently to global health threats.

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