Increased Productivity and Efficiency Among Cancer Center Clinical Trials Workforce during the COVID-19 Pandemic

Background: Independent of the SARS-CoV-2 pandemic, we developed a pilot program tracking productivity allowing research coordinators (RCs) to work from home. However, with the pandemic's onset all RCs were ordered to work from home starting March 25, 2020. Simultaneously, all in-person clinical trial site monitoring visits were prohibited, forcing sponsors to either halt research monitoring operations (10%) or adapt to remote monitoring (90%). We analyzed the productivity and efficiency of RCs during at home days versus in office days to better understand the impact of the pandemic on clinical trial operations. Methods: During this study period, RCs performed daily productivity tracking in a RedCap database, whether at the office or at home. Productivity was defined as total data fields entered;efficiency was defined as data fields entered in a given time period. Continuous variables were summarized using the median and interquartile range (IQR). To account for the fact that the data are clustered by RC, comparisons between working location were made using a logistic regression model with a random intercept for RC. A p-value <.05 was considered statistically significant. RCs who entered values incorrectly or who entered/exited the team during the tracking period were excluded. The data entry work was also categorized into 16 distinct disease groups for analysis. Results: There were 2,369 observations recorded by 58 RCs between March 2 and June 29, 2020. 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 office (P=.5). All 58 RCs recorded a total of 17,966 hours over 81 days working at home, where 24 of the RCs recorded a total of 1,169 hours over 69 days working from the office (Tables 1 and 2). For all disease groups, the median number of hours worked by RCs from home and the office were 8.00 (IQR 7.92-8.10) and 8.50 (IQR 7.91-10.00), respectively (P=.046). On average, RCs entered significantly more data fields at home (95.5, IQR 32-240) compared to at the office (75, IQR 35-145, P<.001). There was no significant difference in the number of patients for whom data were entered. There was a trend towards an increase in the median number of data fields entered per hour from home (40, IQR 20-72) compared to the office (21, IQR 13-36, P=.064, Tables 3 and 4). Among the hematology group, the median number of hours worked by RCs from home and the office were 8.00 (IQR 7.90-8.05) and 8.02 (IQR 7.92-8.36), respectively (P=.1). The median number of data fields entered by RCs from home and the office were 150 (IQR 47-336) and 74 (IQR 41-164), respectively (P<.001), and the median number of data entry hours for RCs from home and the office were 3.50 (IQR 2-5) and 2.62 (IQR 1.56-3), respectively (P=.004). There was no significant difference in the number of patients for whom data were entered or the number of data fields per hour. Among the solid tumor group, the median number of hours worked by RCs from home and the office were 8.00 (IQR 7.95-8.18) and 9.87 (IQR 7.87-10), respectively (P=.2). There was no significant difference in the number of data fields entered, the number of data entry hours, nor the number of data fields entered per hour. Hematology RCs completed a median of 150 (IQR 47-329) data fields per day while the solid tumor RCs completed a median of 65 (IQR 25-159) data fields per day. The multiple myeloma and leukemia groups completed the most data fields per day, 320 (IQR 200-650) and 202 (IQR 58.5-390), respectively (Tables 5 and 6). Total median time spent on data entry and total median time spent on all other tasks was 2.98 hours and 5.28 hours respectively, meaning 36% of an RCs work was comprised of data entry tasks. With the hematology research RCs bearing the brunt of the data entry workload, per hour, RCs completed nearly double the average amount of data fields when at home (40, IQR 20-72 vs 21, IQR 13-36). This translates into RCs being 17% more efficient overall when working at home. Conclu ions: A silver lining to the SARS-CoV-2 pandemic includes increased data entry by RCs, and virtual monitoring and site initiation visits by sponsors and contract research organizations. These have created efficiencies including a greater number of trials opened and a reduction in trial times to open, when compared to a similar time period in 2019. Preliminary employee satisfaction surveys also reveal a high degree of satisfaction when working from home. Disclosures Gerds:Apexx Oncology: Consultancy;Imago Biosciences: Research Funding;AstraZeneca/MedImmune: Consultancy;Roche/Genentech: Research Funding;Gilead Sciences: Research Funding;Incyte Corporation: Consultancy, Research Funding;Sierra Oncology: Research Funding;Celgene: Consultancy, Research Funding;Pfizer: Research Funding;CTI Biopharma: Consultancy, Research Funding. Pennell:Cota: Consultancy;Eli Lilly: Consultancy;Amgen: Consultancy;Genentech: Consultancy;Merck: Consultancy;Astrazeneca: Consultancy;BMS: Consultancy;G1 Therapeutics: Consultancy;Inivata: Consultancy. Sekeres:Takeda/Millenium: Consultancy;BMS: Consultancy;Pfizer: Consultancy.

Outcomes of patients with hematologic malignancies and COVID-19: a report from the ASH Research Collaborative Data Hub.

Coronavirus disease 2019 (COVID-19) is an illness resulting from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that emerged in late 2019. Patients with cancer, and especially those with hematologic malignancies, may be at especially high risk of adverse outcomes, including mortality resulting from COVID-19 infection. The ASH Research Collaborative COVID-19 Registry for Hematology was developed to study features and outcomes of COVID-19 infection in patients with underlying blood disorders, such as hematologic malignancies. At the time of this report, data from 250 patients with blood cancers from 74 sites around the world had been entered into the registry. The most commonly represented malignancies were acute leukemia (33%), non-Hodgkin lymphoma (27%), and myeloma or amyloidosis (16%). Patients presented with a myriad of symptoms, most frequently fever (73%), cough (67%), dyspnea (50%), and fatigue (40%). Use of COVID-19-directed therapies, such as hydroxychloroquine (n = 76) or azithromycin (n = 59), was common. Overall mortality was 28%. Patients with a physician-estimated prognosis from the underlying hematologic malignancy of <12 months at the time of COVID-19 diagnosis and those with relapsed/refractory disease experienced a higher proportion of moderate/severe COVID-19 disease and death. In some instances, death occurred after a decision was made to forgo intensive care unit admission in favor of a palliative approach. Taken together, these data support the emerging consensus that patients with hematologic malignancies experience significant morbidity and mortality resulting from COVID-19 infection. Batch submissions from sites with high incidence of COVID-19 infection are planned to support future analyses.

Consensus minimum hemoglobin level above which patients with myelodysplastic syndromes can safely forgo transfusions.

The anemia of MDS often results in decreased quality of life, which is invoked to justify red cell transfusions; however, there are sparse data regarding the minimum hemoglobin (Hb) at which it is safe to forgo transfusions for patients with no evidence of end-organ damage. This issue is even more important in the COVID-19 era, where decreases in blood donations have stressed the blood supply. In March 2018, using a modified Delphi method, we convened a panel of 13 expert MDS clinicians for three iterative rounds to discuss a minimum safe Hb for this population. While the panel was unable to reach the pre-set consensus of 75% for a specific Hb threshold, there was 100% consensus that it be no greater than 7.5 g/dL. Our data suggest that, given no end-organ effects of anemia, patients with MDS can safely forgo transfusions with a Hb of 7.5 g/dL or higher.

Special considerations in the management of adult patients with acute leukaemias and myeloid neoplasms in the COVID-19 era: recommendations from a panel of international experts.

The ongoing COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 is a global public health crisis. Multiple observations indicate poorer post-infection outcomes for patients with cancer than for the general population. Herein, we highlight the challenges in caring for patients with acute leukaemias and myeloid neoplasms amid the COVID-19 pandemic. We summarise key changes related to service allocation, clinical and supportive care, clinical trial participation, and ethical considerations regarding the use of lifesaving measures for these patients. We recognise that these recommendations might be more applicable to high-income countries and might not be generalisable because of regional differences in health-care infrastructure, individual circumstances, and a complex and highly fluid health-care environment. Despite these limitations, we aim to provide a general framework for the care of patients with acute leukaemias and myeloid neoplasms during the COVID-19 pandemic on the basis of recommendations from international experts.