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Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials During the COVID-19 Pandemic
Juliet Emamaullee1, Michael Bowdish1, Pui Yuk Yan2
1Department of Surgery, University of Southern California, Los Angeles, California; Keck School of Medicine, University of Southern California, Los Angeles, California.
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 expertise within a department of surgery can successfully accommodate a crisis situation and rapidly adapt to new requirements for the safe, efficient, and effective conversion to a remote work force without compromising the research process.
Insights
The COVID-19 pandemic disrupted clinical trials, necessitating rapid adaptation. This study outlines strategies for safely continuing research and launching new trials during the crisis.
Area of Science:
- Clinical Research
- Pandemic Response
- Surgical Trials
Background:
- The COVID-19 pandemic significantly disrupted ongoing clinical trials.
- There is an urgent need for effective COVID-19 treatments, highlighting the importance of rigorous research.
- Public health measures like "stay at home" orders impacted research personnel and study conduct.
Purpose of the Study:
- To describe the adaptive strategies of a clinical trials unit during the COVID-19 pandemic.
- To ensure participant safety and data integrity in ongoing and new clinical studies.
- To demonstrate the successful transition to remote operations without compromising research quality.
Main Methods:
- Implementing safety protocols for study participants.
- Adapting study procedures for remote data collection and participant monitoring.
- Leveraging existing infrastructure for rapid trial initiation and management.
- Establishing a remote work environment for research staff.
Main Results:
- Successful continuation of ongoing clinical studies with necessary adjustments.
- Safe enrollment and follow-up of participants in studies offering potential benefits.
- Rapid implementation of new clinical trials focused on COVID-19.
- Effective transition to a remote workforce, maintaining research operations.
Conclusions:
- A dedicated Division of Clinical Research within a surgical department can effectively manage crisis situations.
- Adaptability and strategic planning are crucial for maintaining clinical research during pandemics.
- The established infrastructure facilitated a safe and efficient pivot to remote research operations.
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