A new project led by the Cardiac Safety Research Consortium created a first-in-kind data warehouse to help ensure comprehensive cardiac safety review for therapeutic product development for children.
A first-in-kind Cardiac Safety Research Consortium (CSRC) project has the potential for significant public health advances in the field of pediatric clinical trials.
Founded in 2006 by the FDA and Duke University, the CSRC has overseen a number of successful projects and initiatives. DCRI’s Mitchell Krucoff, MD, is the principal investigator, and Valarie Morrow, MD, is the project leader. The aim of the CSRC is to engage stakeholders from industry, academic, and government agencies to support research into the evaluation of the cardiac safety of medical products.
In late 2020, the CSRC announced the establishment of a pilot project called Prevention of Sudden Cardiac Death in the Young (SCDY), which created a first-in-kind pediatric electrocardiogram (ECG) data warehouse. The intent behind the SCDY project was to help identify and overcome barriers to effective pediatric cardiac screening, a goal shared by a number of stakeholders across the biomedical community.
The FDA already utilizes an ECG data warehouse to support its cardiac safety review of therapeutic product development programs; however, there is no equivalent pediatric ECG data warehouse. Therefore, it is much more difficult to ensure comprehensive cardiac safety review for therapeutic product development for children.
The SCDY project is a partnership, via the CSRC, between the FDA, the DCRI, and medical industry consortium members. The SCDY project’s principal investigator is Duke pediatric cardiologist Salim F. Idriss, MD, PhD, who is Executive Co-Director of the Duke Pediatric and Congenital Heart Center as well as Director of Duke Pediatric Electrophysiology. DCRI Government Trials & Networks oversaw the project management, informatics, statistics, and data management for the project.
In August 2021, Idriss and Shetarra Walker, MD, MSCR, from FDA’s Center for Drug Evaluation and Research, published an article about how the data warehouse was developed and its potential impact on the field of pediatric clinical trials.
The multidisciplinary project, Idriss and Walker wrote, involved partnering with public groups which conduct cardiac screenings in children in the U.S. These screenings include recording an ECG as well as obtaining symptom and family history. Because the majority of these groups are parent-led foundations, collaboration with the public was essential to the creation of the database. Despite interruptions to their screening efforts owing to the COVID-19 pandemic, the public groups have provided almost 40,000 ECGs to the database to date.
Ultimately, the data warehouse and these relationships with screening partners will enable access to high-quality pediatric data on a scale that will allow research into a wide array of cardiac issues. It may even enable researchers to improve clinical guidelines for assessing cardiac risk in children, develop better pre- and post-market cardiac safety evaluation in children, and develop biomarkers for use in pediatric clinical trials.
Visit the FDA’s website to read the summary of the project, or learn more about the CSRC as a whole.