A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19: CCC19 Governance, Protocol, and Quality Assurance

Abstract

When the COVID-19 pandemic began, formal frameworks to collect data about affected patients were lacking. The COVID-19 and Cancer Consortium (CCC19) was formed to collect granular data on patients with cancer and COVID-19 at scale and as rapidly as possible. CCC19 has grown from five initial institutions to 125 institutions with >400 collaborators. More than 5,000 cases with complete baseline data have been accrued. Future directions include increased electronic health record integration for direct data ingestion, expansion to additional domestic and international sites, more intentional patient involvement, and granular analyses of still-unanswered questions related to cancer subtypes and treatments.

Figure 1

CCC19 Data Collection Schema and Participating Institutions (A) The general schema for data collection. (B) Participating institutions as of October 3, 2020. Current participants include 10 NCI-Designated Cancer Centers; 43 NCI-Designated Comprehensive Cancer Centers; 25 NCI Community Oncology Research Program (NCORP) community sites, of which 10 are designated as Minority/Underserved; and 10 international sites (Canada and Mexico). Image source: NCI (public domain). ECOG PS, Eastern Cooperative Group performance status; BMI, body mass index; irAEs, immune-related adverse events.

Figure 2

Distribution of Curation Times and Quantitative Improvement in Quality Score after the First Round of Feedback to Sites (A) Time intervals are determined by taking the difference between timestamps as recorded by REDCap at the initiation of each of the baseline forms. Outliers (negative calculated time, or calculated time greater than 120 min) are removed. (B) The red curve illustrates the state of the registry at the time of the fourth data lock (July 31, 2020); at that time, fewer than 80% of records met the quality threshold. Targeted feedback was provided to sites ∼2 weeks later, and after 2 months the Quality Score had improved such that 88% of cases met the threshold to qualify as analytic cases.