Participation in ENSEMBLE phase III multicenter clinical trial of Ad26.CoV2.S, a COVID-19 vaccine: An investigational drug services perspective

Abstract

What is known and objective: Since WHO declared the pandemic of COVID-19, vaccines have been developed to fight against this infectious disease. Coordination and participation of investigational drug services to facilitate a phase III COVID-19 vaccination clinical trial are described and discussed, with novel interventions coordinating the dispensing processes in the trailer settings. Comment: Once the study has reached phase III, the large number of participants and fast enrolment would contribute to the vaccine development. What is new and Conclusion: The investigational drug service (IDS) performed responsibilities in clinical and trailer units, and minimized workflow disturbances to maximize validity during the dispensing process. The advantages of mobile units and trailers increase flexibility of participants, broaden service area and improve feasibility, especially in minority and underserved communities. The UCM IDS team performs responsibilities in both clinical and mobile unit settings, the IDS team is able to facilitate and expand the enrolment to the minority population in underserved communities.