Abstract
Background Timely response to identify and optimize therapeutics during outbreaks of (re-)emerging infectious diseases remains a challenge.
Objective This study aimed to investigate operational issues encountered by a participating site of REMAP-CAP, an international adaptive platform trial, the Regional Management Committee (RMC) in Japan, and the Clinical Trial Coordination (CRC) office when the COVID-19 Immune Modulation-2 Domain, an investigator-initiated trial (IIT) of Investigational New Drug grade was conducted amidst the COVID-19 pandemic.
Methods Themes were extracted from meeting minutes of the trial meetings and focus group discussions at the participating site. Individual interviews with RMC and the in-house CRC office of the participating site revealed additional insights. These topics were qualitatively analyzed and categorized into “IIT-specific” or “COVID-19 pandemic-specific” across the trial phases.
Results The IIT-specific issues included the overwhelming paperwork burden of in-house CRC office and strenuous coordination work of RMC with multiple stakeholders. The COVID-19 pandemic-specific issues included mental stress of frontline healthcare workers in an isolation unit caused by additional tasks of IIT operations, and the crucial need of institutional and inter-institutional coordination to conduct an IIT for acute infectious diseases.
Conclusion For a future pandemic, it is essential to proactively assess capacity and capability of participating sites and to appropriately manage the workload and trial progress. Furthermore, additional measures are required in advance to alleviate the burden of frontline healthcare workers as the trial execution may be impacted by their mental and physical burden and their acceptance of the trial.
