Resilient Clinical Trial Infrastructure in Response to the COVID-19 Pandemic: Lessons Learned from the TOGETHER Randomized Platform Clinical Trial

View More View Less
  • 1 Platform Life Sciences, Vancouver, Canada;
  • | 2 University of British Columbia, Vancouver, Canada;
  • | 3 University of Aberdeen, Aberdeen, Scotland;
  • | 4 McMaster University, Hamilton, Canada;
  • | 5 CardResearch, Belo Horizonte, Brazil;
  • | 6 Pontifica Católica Universidade de Minas Gerais, Belo Horizonte, Brazil

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.

Author Notes

Address correspondence to Edward J. Mills, Department of Health Research Methods, Evidence, and Impact, Faculty of Health Sciences, McMaster University, 1280 Main St. West, Hamilton, Ontario, L8S 4L8, Canada. E-mail: millsej@mcmaster.ca

Financial support: Rainwater Charitable Foundation supported this research and has no role in the conduct of the research or findings of this publication.

Authors’ addresses: Jamie I. Forrest, Platform Life Sciences, Vancouver, Canada, and University of British Columbia, Vancouver, Canada, E-mail: jforrest@platformsciences.ca. Angeli Rawat and Felipe Duailibe, University of British Columbia, Vancouver, Canada, E-mails: angeli@alumni.ubc.ca and felipetduailibe@hotmail.com. Christina M. Guo, Platform Life Sciences, Vancouver, Canada, and University of Aberdeen, Aberdeen, Scotland, E-mail: cguo@platformsciences.ca. Sheila Sprague, McMaster University, Hamilton, Canada, E-mail: sprags@mcmaster.ca. Paula McKay, CardResearch, Belo Horizonte, Brazil, E-mail: mckayp@mcmaster.ca. Gilmar Reis, CardResearch, Belo Horizonte, Brazil, and Pontifica Católica Universidade de Minas Gerais, Belo Horizonte, Brazil, E-mail: greisbh@uol.com.br. Edward J. Mills, Platform Life Sciences, Vancouver, Canada, and McMaster University, Hamilton, Canada, E-mail: millsej@mcmaster.ca.

Save