Five years after the start of the COVID-19 pandemic, the research community is reflecting on the historic research response to understand the disease and develop diagnostics, therapies, and vaccines.
In a special thematic issue of the Journal of Clinical and Translational Science, a set of papers outlines the most critical takeaways for the public health and research communities that should be applied to future public health emergencies.
The issue, COVID-19 Therapeutic Platform Trials Lessons Learned, includes an opening editorial and nine research articles that break down the most significant learnings from Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) research – the U.S. government’s COVID-19 research agenda and response.
Duke Clinical Research Institute (DCRI) research is highlighted in the issue, as the DCRI served as a key academic partner in ACTIV research.
The authors present brief summaries and takeaways from manuscripts, such as the importance of centralized resources, community outreach for efficient enrollment of specific populations, and the value of global clinical trial collaboration.
DCRI Data Science and Biostatistics director Chris Lindsell, PhD, is the lead author of the paper, The statistical design and analysis of pandemic platform trials: Implications for the future.
“When the next crisis comes, I think that we will want to open up this thematic issue and read it,” he said. “This set of papers offers an update on the state of the country’s ability to respond to a pandemic. It offers opportunities to be better positioned to respond next time.”
The authors describe statistical design choices that were initially made, the necessary adaptations made, and recommendations for future organization of master protocols. They also outline key considerations, like selecting endpoints and navigating unexpected trial design changes. The authors suggest prioritizing fewer but larger master protocols during the next pandemic.
The DCRI is also highlighted in the review article, Engaging communities in therapeutics clinical research during pandemics: Experiences and lessons from the ACTIV COVID-19 therapeutics research initiative.
Duke authors include Lindsell and Patty McAdams, Julia Vail, MA, PMP, and Susanna Naggie, MD. The paper describes approaches taken by ACTIV and its study protocol teams to increase public awareness about the trials, publicize the studies to potential participants, and engage communities most impacted by the pandemic. It includes practical recommendations, like beginning community involvement as early as possible and using traditional (non-web) media to reach those less connected.
Other articles of interest, led by Duke faculty, in this edition include:
- Christina Barkauskas, MD: ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic
- Ahmad Mourad, MD (DCRI faculty): Lessons learned from the conduct of inpatient clinical trials in a pandemic
- Thomas Holland, MD (DCRI faculty): Practical application of good participatory practices for trials of emerging pathogens: Developing materials for use in ACTIV-3, -3b, and ACTIV-associated COVID-19 trials
“The DCRI took leadership on the national stage when there was a crisis,” Lindsell said. “We are now thinking about what we learned for next time, which is the fundamental ethos of the DCRI. We learn from each trial to make the next one better.”
That’s why the DCRI is well-positioned to do creative research and lead during a crisis like a pandemic, Lindsell said.
“We focus on getting the science right and partnering with the right thought leadership in operations, data science, and clinical research. When you put those together, you can shake things up and come up with a solution to almost any problem,” he said.
Lessons learned from ACTIV COVID-19 research should be used to create an inclusive and efficient clinical trials enterprise, according to the authors.
“We’ve learned so much on the importance of collaborating early and balancing stakeholder perspectives,” Lindsell said. “I think that overall science will be better because of the pandemic, assuming that we learn and don’t go back to where we were before."