While researchers have formed cooperative groups to share and standardize data for several decades, there are several reasons that the scientific community needs a new vision of data sharing.
Manual processes: Currently, clinical research coordinators document and maintain extensive research records in paper binders. Paper documentation and manual extraction into electronic databases is at best inefficient and at worst, error prone and dangerous. Multiple layers of data checking and auditing are required to help ensure completeness and accuracy. Physical storage and archiving of research shadow binders alongside electronic databases is costly and can result in misplaced or lost protected health information (PHI). Let’s face it–pediatric clinical trials are stuck in the 1990s!
Automatic extraction of data from electronic health records into secure databases reduces opportunity for errors in data sets; stores patients’ data more securely; and reduces the workload of clinical research coordinators, allowing them to focus more energy on patient-related research concerns.
Lack of data standards: When data are gathered independently and siloed in individual databases, it can be difficult or impossible to merge the data together. For example, researchers may have different ways of categorizing tumor types and/or sites. If these categories and values cannot be aligned, the data on these variables cannot be compared. Even when data can be combined, the process of harmonizing data from disparate sources retrospectively can be cumbersome and extremely time-consuming. In order to aggregate enough patient data to power studies that are capable of making truly-significant discoveries in pediatric oncology, researchers around the world must work together to establish universal data standards so that they can collect data prospectively in unison. Our UChicago PCDC team is passionate about standards and interoperability.
Differing data models: There are several oncology data models in existence at present. The international pediatric oncology field must work together to create an agreed-upon, comprehensive data model alongside its data standards consensus work so that data from different sources can be unified into a singular location. The UChicago PCDC team is creating a culture of data stewards among the pediatric oncology research community, encouraging everyone to take responsibility for how data are collected, stored, and shared.
International regulations: Significant advances in pediatric cancer research depend on large sample sizes and rich data sets. Now that the necessary technology and clinical research data exist worldwide, researchers have been trying to share data across borders to make more meaningful discoveries together. However, laws and regulations around clinical research data, protected health information (PHI), and data privacy and security make sharing data sets across international boundaries difficult and costly. Research teams enter into data sharing agreements and contracts with the help of their respective legal teams.
Though the creation of cooperative research groups has helped to streamline some of these processes, this work must still be duplicated by researchers in different disease groups. By creating a central pediatric cancer data commons, our team is able to utilize our experts in international data laws and data governance to streamline this process for cooperative groups across multiple pediatric cancers. This centralized expertise not only expedites the laborious process of contract writing, but significantly reduces costs and time for researchers, so that they can focus their time and funds on their research and patients.