Speakers
Pamela Tenaerts, MD, MBA
Executive Director
Clinical Trials Transformation Initiative
Sara Calvert, PharmD
Senior Project Manager
Clinical Trials Transformation Initiative
Leanne Madre, JD, MHA
Directory of Strategy
Clinical Trials Transformation Initiative
Topic
How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic
Keywords
Clinical Trials Transformation Initiative (CTTI); Best practices; COVID-19 treatment trials; RECOVERY Trial; Digital health technology; Decentralized clinical trials
Key Points
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During 2020, CTTI conducted a series of intensive surveys, discussions, and collaborations across the clinical trials ecosystem, which shaped the creation of public webinars, a Best Practices for Conducting Trials During the COVID-19 Pandemic playbook, and a searchable, real-time AACT COVID-19 Trials Spreadsheet, among other efforts.
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CTTI’s efforts helped the research community successfully navigate the challenges associated with adjusting trials that were underway when the pandemic hit, as well as launching new trials for COVID-19 treatments.
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Among the best practices for conducting clinical trials during the pandemic: keep participants informed, perform ongoing risk-benefit assessment, adjust study startup and enrollment based on current risks, pivot to remote study visits, and switch to remote monitoring.
Discussion Themes
Because of the COVID-19 pandemic, there is more momentum toward digital health technology and decentralized clinical trials.
With the pandemic, we are seeing trial results go straight to practice, bypassing input from the clinical community at large—will this continue after the pandemic?
To what extent do you think the IRB/research oversight sphere might be permanently reshaped by the pandemic’s impact on the conduct of clinical trials?
Read more about CTTI’s efforts around clinical trials during the COVID-19 pandemic.
Tags
#pctGR, @Collaboratory1