| Autor: |
Levine CB; Corri B. Levine, PhD, MS, MPH, is Program Manager, Division of Infectious Diseases, Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX., Vasistha S; Sami Vasistha, MS, is Program Manager, Global Center for Health Security and National Emerging and Special Pathogens Training and Education Center (NETEC), University of Nebraska Medical Center, Omaha, NE., Persson CC; Caroline Croyle Persson, MPH, MPA, CPH, CIC, is Project Director, Biocontainment Unit, Denver Health and Hospital Authority, Denver, CO., Larson LR; LuAnn R. Larson, RN, BSN, is Director of Clinical Research, Center for Clinical and Translational Research and NETEC, University of Nebraska Medical Center, Omaha, NE., Kratochvil CJ; Christopher J. Kratochvil, MD, is Associate Vice Chancellor for Clinical Research, Center for Clinical and Translational Research, University of Nebraska Medical Center, Omaha, NE., Mehta AK; Aneesh K. Mehta, MD, is a Professor, Division of Infectious Diseases, and Co-Principal Investigator, NETEC, Emory University School of Medicine, Atlanta, GA., Hicks LJ; Lindsay J. Hicks is IRB Administrator II, Office of Regulatory Affairs, University of Nebraska Medical Center, Omaha, NE., Lowe AE; Abigail E. Lowe, MA, is an Assistant Professor, College of Allied Health Professions, University of Nebraska Medical Center, Omaha, NE., Kortepeter MG; Mark G. Kortepeter, MD, MPH, is Former Director, Special Pathogens Research Network, NETEC, and is a Professor, Department of Epidemiology, College of Allied Health Professions, University of Nebraska Medical Center, Omaha, NE., Sauer LM; Lauren M. Sauer, MSc, is Director, Special Pathogens Research Network, NETEC, and an Associate Professor, Department of Environmental, Agricultural, and Occupational Health, College of Public Health, Global Center for Health Security, University of Nebraska Medical Center, Omaha, NE. |
| Abstrakt: |
The need for well-controlled clinical trials is fundamental to advancing medicine. Care should be taken to maintain high standards in trial design and conduct even during emergency medical events such as an infectious disease outbreak. In 2020, SARS-CoV-2 emerged and rapidly impacted populations around the globe. The need for effective therapeutics was immediately evident, prompting the National Institutes of Health to initiate the Adaptive COVID-19 Treatment Trial. The Special Pathogens Research Network, made up of 10 Regional Emerging Special Pathogens Treatment Centers, was approached to participate in this trial and readily joined the trial on short notice. By trial closure, the Special Pathogens Research Network sites, making up 19% of all study sites, enrolled 26% of the total participants. The initial resources available and experience in running clinical trials at each treatment center varied from minimal experience and few staff to extensive experience and a large staff. Based on experiences during the first phase of this trial, the Special Pathogens Research Network members provided feedback regarding operational lessons learned and recommendations for conducting future studies during a pandemic. Communication, collaboration, information technology, regulatory processes, and access to resources were identified as important topics to address. Key stakeholders including institutions, institutional review boards, and study personnel must maintain routine communication to efficiently and effectively activate when future research needs arise. Regular and standardized training for new personnel will aid in transitions and project continuity, especially in a rapidly evolving environment. Trainings should include local just-in-time training for new staff and sponsor-designed modules to refresh current staff knowledge. We offer recommendations that can be used by institutions and sponsors to determine goals and needs when preparing to set up this type of trial for critical, short-notice needs. |
