Abstract: PO2530
Maintaining Operational Excellence During the COVID-19 Pandemic in the FLOW Trial
Session Information
- Late-Breaking Clinical Trials Posters
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Coronavirus (COVID-19)
- 000 Coronavirus (COVID-19)
Authors
- Pratley, Richard E., AdventHealth Translational Research Institute, Orlando, Florida, United States
- Bakris, George L., The University of Chicago Medicine, Chicago, Illinois, United States
- Bax, Willem A., Northwest Clinics, Alkmaar, Netherlands
- Bosch-Traberg, Heidrun, Novo Nordisk A/S, Søborg, Denmark
- Mahaffey, Kenneth W., Stanford University School of Medicine, Palo Alto, California, United States
- Rossing, Peter, Steno Diabetes Center Copenhagen, Gentofte, Denmark
- Tuttle, Katherine R., University of Washington and Providence Health Care, Spokane, Washington, United States
- Lawson, Jack, Novo Nordisk A/S, Søborg, Denmark
- Møntegaard, Camilla, Novo Nordisk A/S, Søborg, Denmark
- Wassermann, Alfredo, FEPREVA, Buenos Aires, Argentina
- Mann, Johannes F., KfH Kidney Center, Munich, Germany
Background
The FLOW trial is a multicenter, international, randomized, phase 3b kidney outcomes trial of once-weekly subcutaneous semaglutide vs placebo, both added to standard-of-care, in >3,500 people with type 2 diabetes and chronic kidney disease. The trial is guided by a steering committee with academia and industry representatives and a global expert panel (GEP). The coronavirus disease 2019 (COVID-19) pandemic has presented major challenges for running clinical trials, with restrictions for trial sites impacting recruitment and retention. Once the extent and hazards of COVID-19 were apparent, regular impact assessments were done to quickly identify and mitigate challenges to the conduct of the trial. Here, we report the timing of mitigation strategies in the FLOW trial and the relationship to recruitment during the pandemic.
Methods
The primary focus was to ensure participant and staff safety and no undue risk of COVID-19 exposure, as well as data integrity, recruitment and retention. These aims were met by implementing protocol amendments, guidance documents for trial sites and local support from GEP members, through strategies such as replacing face-to-face visits with phone and home visits, remote monitoring, alternative trial drug dispensing and allowing for co-participation in COVID-19 trials (Figure).
Results
After the mitigation strategies were employed in response to the COVID-19 pandemic, the FLOW trial recruitment was completed according to schedule (Figure). To date, no participants have withdrawn from the FLOW trial due to COVID-19.
Conclusion
After the rapid identification and implementation of mitigation strategies and efforts of the steering committee and GEP, the FLOW trial successfully recruited the planned number of participants on time and avoided withdrawals due to COVID-19.
Funding
- Commercial Support – Novo Nordisk A/S