Observational data systematically collected using registries can help confirm the presence of an outbreak, identify risk factors, assess common symptoms of the disease, determine the disease progression rate, identify successful treatments, and provide insights into long-term outcomes. The COVID-19 experience demonstrates that barriers exist to meaningful data sharing across registries during a pandemic that may limit our ability to leverage real-world data in a timely fashion and ultimately make strategic decisions.

Current COVID-19 Registry Capabilities

As the pandemic continues, a need exists to collect data on symptoms, treatment, and patient outcomes. As a result, the Department of Health and Human Services (HHS), medical societies, healthcare organizations, and other stakeholders endeavor to create clinical registries or expand existing case report forms to include COVID-19-related data elements.

Various departments within HHS are actively collecting COVID-19 data. Specifically, the Center for Disease Control is collecting data about hospitals’ daily COVID-19 census and capacity as well as outcome data, such as mortality.  Additionally, the Food and Drug Administration and the National Center for Advancing Translational Sciences / National Institutes of Health have launched the CURE ID app/web platform that allows the clinical community to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19.

Outside the federal government, many medical societies have moved rapidly to include COVID data elements into existing registry case report forms or have created standalone registries or survey instruments to supplement their existing registry data. The American Society of Clinical Oncology (ASCO), for example, has created the Survey on COVID-19 in Oncology Registry (ASCO Registry), which is intended to identify patterns of symptoms and severity of COVID-19 among patients with cancer, as well as how the pandemic is impacting the delivery of cancer care and patient outcomes. The ASCO Registry will focus on collecting data and outcomes data into 2021 for oncology patients. Information that is currently being collected via the ASCO Registry is publicly available on their website. Partnerships have also been established to collect COVID data, including the VIRUS registry by the Society of Critical Care Medicine and Mayo Clinic. Currently, over 100 hospitals are participating in the VIRUS registry, and data are being publicly posted on specific data points on the VIRUS dashboard for adult and pediatric patients who are admitted to a hospital.

While the exact number of registries collecting COVID-specific data in the US is largely unknown, the Infectious Disease Society of America has established a directory of COVID registries where those collecting COVID data can “opt in” to having their information included. As of today, approximately 40 registries are included, representing only a fraction of US registries collecting COVID-specific data elements.

COVID Registry Challenges

Despite the uptick in COVID-19 data collection, to date there has been limited discussion between interested stakeholders regarding how best to coordinate the use of public data collected by HHS with data collected by clinical registries.  Given this limited coordination, challenges exist to leveraging data collected by registries:

• Registries lack common data elements for a pandemic disease. Unlike the established common data elements currently used in the US, different registries are capturing COVID-19 data in different formats and collecting different data elements. These differences make it challenging to combine data elements from multiple registries in a meaningful way that could help facilitate the analysis of pandemic-specific trends using real-world data.
• Registry data collection methods vary. Each registry has developed its own case report form/data collection instrument to capture data elements of interest. Registries may leverage distinct approaches to data collection, with some collecting patient-level data and others aggregating data without specific markers enabling linking the aggregate data with individual patient data. This can make analysis across registries challenging.
• Registries data do not capture the patient journey. Registries have taken different approaches to data collection. Some registries begin collecting data once the patient is hospitalized for COVID but fail to track rehabilitation and recovery data. This can somewhat limit the ability to view and assess longitudinal outcomes beyond mortality.

Moving Forward: Opportunities for Stakeholders

As we look to the future, anticipating future pandemics, an opportunity exists for stakeholders to come together early and identify common data elements that should be collected, using these specific steps:

• Creating a minimum data set and aligning on how the common data elements are defined: Creating a minimum dataset that documents key COVID patient demographic, risk factors, treatments, and management should be considered. An increasingly global society requires standardization of the depth and breadth of data to be captured that tracks such patient information as recent travel, a close contact’s recent travel, or where a person lives or works to aid in rapidly assessing population level risk of disease.
• Ensuring a mechanism exists to link patient data from multiple sources: Some registries may only seek to collect data on part of a COVID patient’s journey, so a need exists to link data from multiple public and private data sources, including registries. This would allow us to track patient data across care settings from diagnosis to recovery. Efforts should be made to ensure that this information can be secured in a timely fashion to facilitate research and care delivery.
• Addressing data privacy and security issues: Building a registry infrastructure should include consideration of many factors, including detailed planning around data privacy and security, local and national considerations, regulatory and ethical considerations, and clinical and research knowledge, to create a registry that could be stood up immediately in the face of an emerging pandemic.

Broad stakeholder engagement by departments within HHS and other interested stakeholders, such as medical societies, registry developers, and patient organizations, may help facilitate the ability to leverage real-world data to provide a better, more complete picture on COVID care during a pandemic. Avalere has tackled many of these challenges when engaging medical societies, life science companies, and other clients in registry development. Leveraging strategies such as convening stakeholder to identify disease-specific common data elements, creating and refining data dictionaries and case report forms, and developing common forms for facilitating data sharing ensures that the US will have usable data that can facilitate answering research questions, and improve healthcare delivery and overall patient care. Incorporating such strategies can be done incrementally, moving the US toward establishing a national resource to successfully track and monitor treatment and management of COVID-19.

Check out our COVID-19 Intel Center.

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