Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials During the COVID-19 Pandemic.

The Journal of Surgical Research
Juliet EmamaulleeLinda S Sher

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has brought most ongoing clinical trials to a standstill, while at the same time emphasizing the need for new therapeutic treatments and strategies to mitigate the morbidity and mortality related to COVID-19. Recent publication of several observational studies has generated much discussion surrounding efficacy of drugs including hydroxychloroquine, azithromycin, and remdesivir, stressing the need for high-quality prospective, randomized control trials in patients with COVID-19. Ongoing "stay at home" orders and institutional policies mandating "work from home" for nonessential employees, which includes most research personnel, have impacted the ability to implement and conduct clinical studies. This article discusses the approach of an experienced clinical trials unit to make adjustments for ongoing studies and ensure the safety of study participants. At the same time, plans were implemented to continue collection of data to achieve endpoints, safely enroll and follow participants in studies offering potential benefit, and quickly implement new COVID-19 clinical trials. The existence of a Division of Clinical Research with regulatory, budgeting, contracting, and coordinating expe...Continue Reading

References

Feb 1, 2020·The New England Journal of Medicine·Michelle L HolshueUNKNOWN Washington State 2019-nCoV Case Investigation Team
Mar 25, 2020·International Journal of Antimicrobial Agents·Philippe GautretDidier Raoult
Apr 11, 2020·The New England Journal of Medicine·Jonathan GreinTimothy Flanigan

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