Social media advertising and local TV interviews drove a huge number of callers to our call center. How were subjects identified and enrolled so quickly?ĭUKES: Due to the nature of the pandemic and general press coverage, many people were interested in enrolling in the COVID-19 studies.
By moving select non-subject-focused staff to remote work, expanding our hours, and adding a variety of shifts with varying hours, we were able to accommodate all the new hires and expand our hours to accommodate increased enrollment, while at the same time developing more efficient processes via electronic regulatory files and electronic subject source records while maintaining overall high-quality execution. These additions allowed our subject-facing staff to have greater focus on enrollment and subject-related tasks while having other staff attend to the administrative or non-subject-facing activities. This included expanding the number of CRCs as well as adding new roles such as remote CRCs, dedicated EDC staff, safety call specialists, vaccine administration specialists, and QC specialists. How did you increase staff to accommodate the need?ĭUKES: Our staff numbers virtually tripled. In addition to facilities, new technology in the form of electronic regulatory document files and electronic subject source records were implemented to facilitate greater efficiency in operations and transparency for our leadership and staff as well as CRAs and other sponsor staff. Remote working was implemented for non-subject facing tasks (EDC, file maintenance, safety calls, etc.) and additional “stations” were created in the clinics to process volunteers more quickly, all while respecting the requirements for social distancing, masking, and sanitizing. What measures were taken to meet these demands?ĭUKES: It became clear that our facilities were somewhat rate limiting, so, depending on the facility, we expanded with trailers, additional leased space, and flexible work “shifts” to disperse workload over a larger time frame and extend hours of staff coverage and subject enrollment. This included the use of technology, facility modifications and expansions, and alignment of staff roles to meet the goals for enrollment. Was there any additional oversight added due to OWS?ĭUKES: With the accelerated work effort, it was critical to put in place additional checks and balances to ensure the safety of the subjects and the quality of the data. As a result, sites had to quickly change how they operationally approach clinical trials and how they were staffed. Subject enrollment doubled, tripled, or quadrupled the usual rate per month and had to enroll more subjects in a shorter period of time. Sites went from three or four new study starts per quarter to three or four new starts per month.
OPERATION WARP SPEED VACCINES TRIAL
How did Operation Warp Speed (OWS) and the pandemic change what sites require to manage large studies that change rapidly?ĭUKES: The pandemic and OWS accelerated the speed of clinical trial starts and subject enrollment. Benchmark Research is a nine-site network with a core focus in vaccines, diagnostics, and infectious disease clinical trials. Cynthia Dukes, PA, MT, chief business officer of Benchmark Research, addresses the multifaceted challenges of speed and volume of work that required introduction of many changes relative to basic operations, subject recruitment and retention, staffing, and quality data delivery. Thus, this global pandemic highlighted the importance of innovation and adaptability in day-to-day operations of clinical trial sites. These vaccine clinical studies demanded the highest priority by the clinical trial sites conducting them. With a pandemic such as COVID-19, time is of the essence as the virus claims lives, overwhelms healthcare systems, upends daily life, and destabilizes the global economy. Dukes, PA, MT, chief business officer, Benchmark Research
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