A new virtual training series aims to educate and empower clinical researchers to perform rapid response clinical studies in atypical environments.
The Frederick National Laboratory Global Clinical Research Educational Modules (FNL GCREM) is a series of videos that shares expertise, tools, and recommendations to build clinical research infrastructure during infectious disease outbreaks in resource-constrained locations and in areas of armed conflict.
“The program demonstrates how the Frederick National Laboratory for Cancer Research deals with difficult clinical trial scenarios, and it serves as a valuable resource for clinical trial professionals,” said Ethan Dmitrovsky, M.D., director of FNL. “This is part of our mission as a national laboratory.”
The training series explores the conduct of clinical research in challenging conditions and was created by teams with the FNL’s Clinical Monitoring Research Program and the National Institute of Allergy and Infectious Diseases (NIAID) Division of Clinical Research. The training is broken into modules, which cover topics such as protocol development, project management, and regulatory approvals and oversight.
In the last 25 years, the Clinical Monitoring Research Program Directorate has supported 900-plus NIAID global clinical trials for a myriad of infectious diseases, including Ebola, Zika, COVID-19, and mpox.
“The series leverages our expertise in successfully partnering with NIAID to facilitate the conduct of multiple infectious disease trials in various settings during challenging circumstances including global health emergencies,” said CMRPD Director Shelly Simpson. “It’s a great example of how our work and unique experiences on behalf of the government serve not only the clinical trial participants around the world, but also as a resource for our clinical research colleagues.”
Four investigational treatments for Ebola virus disease were tested in a clinical trial in the Democratic Republic of the Congo during the outbreak there that began in August 2018. Clinical Monitoring Research Program teams supported the study, which ultimately identified effective therapies. The trial also demonstrated that high-quality clinical research can be conducted during disease outbreaks, what retired CMRPD director Beth Baseler calls the “new normal.”
The training series launched in early September with four videos, and the team will add new modules over time. CMRPD is a certified provider of continuing education, so qualifying participants can receive continuing education units (CEUs) or continuing medical education (CME) units for completion of the modules.
To access the free training, create an account through the learning system, Edge.
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