Regulatory Focus™ > News Articles > 2021 > 8 > FDA, with academic and community partners, launches first pediatric ECG warehouse

FDA, with academic and community partners, launches first pediatric ECG warehouse

Posted 18 August 2021 | By Kari Oakes 

FDA, with academic and community partners, launches first pediatric ECG warehouse

Pediatric electrocardiogram (ECG) data being collected by the US Food and Drug Administration are now available in a first-of-kind data warehouse.
The warehouse, a mirror of a similar data warehouse for adult ECG data, collects and makes available a rich store of information “to enhance cardiac safety review for therapeutic product development for children,” according to a new FDA Spotlight article announcing the launch of the warehouse.
One prong of the work supported by the pediatric ECG warehouse is investigation into sudden cardiac death in the young (SCDY), a phenomenon whose causes and associations are still not completely understood. Though some SCDY events occur because of a known genetic predisposition, other children die with no previously known arrhythmia or symptoms of disease.
Describing the pediatric ECG warehouse as serving “an important goal shared broadly across the biomedical community,” FDA notes its special expertise in setting community standards for the warehouse. Also, the agency is uniquely positioned to help protect patients from drugs that can prolong the Q-T interval of the cardiac cycle – a known risk for sudden cardiac death. Finally, FDA will continue to curate data about drugs that can affect heart function and look for ECG characteristics that might serve as SCDY biomarkers.
FDA worked with academic pediatric cardiologists and public screening groups on the nuts and bolts of data acquisition and storage, building a set of common data elements with an accompanying universal scannable form. The form, available in electronic and paper formats, allows ECG and demographic data to be uploaded directly to the warehouse.
As part of the project, the multidisciplinary team also developed ECG training materials for screeners, who are often volunteers. Software allows direct conversion of ECG data into the FDA-annotated XML format that is compatible with analysis tools already being employed for the adult ECG warehouse data. Uploads can be accomplished in real time.
To date, almost 40,000 ECGs obtained by PSGs have been uploaded to the database. FDA notes that the ECG training and improved data collection workflow “have already improved the efficiency and quality of data collection by PSGs.”
In future, FDA hopes for “significant public health advances” to flow from the pediatric ECG warehouse. Clinical guidelines to assess risk of SCDY and other cardiac abnormalities in children, more accurate evaluation of the cardiac safety of pediatric therapeutics, and biomarker development.
FDA Spotlight article


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