Development and implementation of the National Heart, Lung, and Blood Institute COVID-19 common data elements

Area of Science:

• Medical Research
• Clinical Trials
• Data Standardization

Background:

• The rapid onset of Coronavirus Disease 2019 (COVID-19) led to swift clinical research, initially lacking standardized data collection.
• This lack of standardization hindered the potential for pooling data from various studies.
• The National Heart, Lung, and Blood Institute (NHLBI) initiated efforts to address this data harmonization gap.

Purpose of the Study:

• To develop a concise set of Common Data Elements (CDEs) for COVID-19 clinical research.
• To facilitate data standardization and pooling across emerging studies.
• To support regulatory submission and data sharing.

Main Methods:

• An iterative development approach guided by three principles: leveraging existing multi-center COVID-19 trials, incorporating existing data standards, and aligning with standards for data sharing and regulatory submission.
• Rapid implementation of CDEs in NHLBI-funded studies.
• Iterative refinement of CDEs based on feedback from study teams.

Main Results:

• The NHLBI COVID-19 CDEs are publicly available and currently utilized in COVID-19 clinical trials.
• CDEs are organized into domains and prioritized using a three-tiered system.
• The CDE manual, data dictionary, and implementation guidance are accessible online.

Conclusions:

• The developed CDEs aid data harmonization, enabling pooled analyses for COVID-19 research.
• The guiding principles facilitated focused development and adaptation to evolving COVID-19 knowledge.
• The CDEs have the potential for generalization to other acute respiratory illnesses.