Kimberly C Jenkins, MSNM from the Cleveland Clinic discusses the ASH 2020 abstract – 3441 Increased Productivity and Efficiency Among Cancer Center Clinical Trials Workforce during the COVID-19 Pandemic.
Context:
We developed a pilot program that monitors efficiency independently of the SARS-CoV-2 pandemic, enabling research coordinators (RCs) to work from home. However, all RCs were ordered to operate from home beginning on March 25, 2020, with the start of the pandemic. At the same time, all monitoring visits to in-person clinical trial sites were banned, forcing sponsors to either suspend study monitoring operations (10 percent) or adapt to remote monitoring (90 percent ). In order to better understand the effect of the pandemic on clinical trial operations, we examined the productivity and performance of RCs during home days compared with office days.
Methodology:
In a RedCap database, RCs conducted regular productivity monitoring, whether at the office or at home, during this study period. Productivity was defined as total data fields entered; efficiency was defined in a given time period as data fields entered. The median and interquartile range were used to summarize continuous variables (IQR). Comparisons were made between working locations using a logistic regression model with a random intercept for RC to account for the fact that the data were clustered by RC. Statistically important was deemed a p-value <.05. It excluded RCs who incorrectly entered values or who entered/exited the team during the monitoring time. The data entry work was also classified for analysis into 16 distinct classes of diseases.
Outcomes:
Between March 2 and June 29, 2020, there were 2,369 observations reported by 58 RCs. RCs spent a median of 2.75 hours (IQR 1.50-4.00) performing data entry at home compared to a median of 3.00 hours (IQR 2.00-5.25) performing data entry in the workplace (P=.5). Over 81 days working at home, all 58 RCs recorded a total of 17,966 hours, with 24 of the RCs recording a total of 1,169 hours over 69 days working from the workplace (Tables 1 and 2). The median number of hours employed by RCs from home and the workplace was 8.00 (IQR 7.92-8.10) and 8.50 (IQR 7.91-10.00) respectively (P=.046) for all disease classes. On average compared with at the workplace, RCs entered substantially more data fields at home (95.5, IQR 32-240) (75, IQR 35-145, P<.001). The number of patients for whom data was entered did not vary significantly. Compared to the workplace (21, IQR 13-36, P=.064, Tables 3 and 4), there was a trend towards a rise in the median number of data fields entered per hour from home (40, IQR 20-72).
The median number of hours worked by RCs from home and office was 8.00 (IQR 7.90-8.05) and 8.02 (IQR 7.92-8.36), respectively (P=.1), among the hematology community. The median number of data fields entered by home and office RCs was 150 (IQR 47-336) and 74 (IQR 41-164), respectively (P<.001), and the median number of hours of data entry for home and office RCs was 3.50 (IQR 2-5) and 2.62 (IQR 1.56-3), respectively (P=.004). The number of patients for whom data was entered or the number of data fields per hour did not vary significantly.
The median number of hours worked by RCs from home and from the office was 8.00 (IQR 7.95-8.18) and 9.87 (IQR 7.87-10) respectively (P=.2) among the solid tumor community. The number of data fields entered, the number of data entry hours, and the number of data fields entered per hour were not substantially different.
A median of 150 (IQR 47-329) data fields per day is completed by hematology RCs, while the solid tumor RCs completed a median of 65 (IQR 25-159) data fields per day. The multiple myeloma and leukemia classes performed the most data fields per day, 320 (IQR 200-650) and 202 (IQR 58.5-390), respectively (Tables 5 and 6).
The total median time spent on data entry and the total median time spent on all other tasks was 2.98 hours and 5.28 hours respectively, which means that data entry tasks constituted 36 percent of the RC work. With the hematology research RCs holding the bulk of the workload of data entry, RCs performed almost double the average number of data fields per hour while at home (40, IQR 20-72 vs 21, IQR 13-36). This means that while operating at home, RCs are 17 percent more successful overall.
Findings:
Increased data entry by RCs, and virtual tracking and site initiation visits by sponsors and contract research organizations provide a silver lining to the SARS-CoV-2 pandemic. Compared to a comparable timeframe in 2019, these have produced efficiencies, including a higher number of trials opened and a decrease in trial times to open. Preliminary studies of employee satisfaction often suggest a high level of satisfaction while working from home.