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Sickle Cell Disease Foundation Announces Research Collaboration with FDA on the Use of Digital Health Technologies to Bridge Health Care Gaps

The Sickle Cell Disease Foundation (SCDF) is proud to announce a research collaboration agreement (RCA) with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health ...

Business Wire

ONTARIO, Calif.: The Sickle Cell Disease Foundation (SCDF) is proud to announce a research collaboration agreement (RCA) with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) to develop best practices for the safe and effective use of artificial intelligence (AI) and machine learning (ML) systems and digitally-derived measures that matter to patients. Specifically, the collaboration will evaluate how digital health technologies can be used to better understand patients’ real-world experiences and evaluate meaningful benefit to those living with rare diseases, like sickle cell disease, for medical product development and public health purposes.

“Despite the recent advancements in treatment, individuals living with sickle cell disease continue to face significant challenges when receiving care. Inadequate knowledge of the disease among health care professionals, lack of research, and poor care coordination, among a few, lead to significant disparities in health outcomes,” said Mary Brown, President and CEO, Sickle Cell Disease Foundation. “We thank our partners, the Center for Inherited Blood Disorders and The Hills Tandem, for their steadfast commitment to this effort and look forward to our collaboration with the FDA to develop analytics and software approaches that will prioritize patients’ real-world experiences. Our collective goal is to improve quality of care and advance personalized medicine for all underserved communities affected by complex chronic and rare diseases through the emerging field of AI/ML health analytics.”

It is anticipated that the collaboration between the FDA and SCDF will lay the groundwork for best practices in the safe and effective use of AI and ML approaches for the development of novel digitally-derived endpoints. By analyzing longitudinal, de-identified patient-generated health data (i.e. granular biometric and self-reported symptoms data), socio-environmental data, and health information, collected from Institutional Review Board-approved studies led by SCDF in partnership with the Center for Inherited Blood Disorders (CIBD) and The Hills Tandem, the collaboration will develop a framework and software solutions to deploy on the data to help predict outcomes from lived experiences data. In addition, the research may provide insight into the use of real-world data to better design post-approval studies and labeling.

“At the FDA, patients are at the heart of everything we do. It is critical that patient input is incorporated into medical product development and throughout the Total Product Life Cycle,” said Vinay Pai, Ph.D., M.B.A., Digital Health Specialist in the Digital Health Center of Excellence at the U.S. Food and Drug Administration. “Collaborating with SCDF will help us to better understand and measure what matters most to patients and advance health equity, with the goal of improving the lives of those living with sickle cell and other rare diseases.”

About the Sickle Cell Disease Foundation

The Sickle Cell Disease Foundation (SCDF) was incorporated in 1957 and is the first and oldest Sickle Cell Disease community-based organization of its kind in the nation. As the only organization in California approved to provide Hemoglobin-Trait Counseling Services and direct the Sickle Cell Educator/Counselor Certification Training Course, SCDF provides life-enhancing education, services and programs for individuals living with Sickle Cell Disease. SCDF broadens public awareness, delivers effective advocacy initiatives, and promotes innovative therapies to ultimately find a cure. Learn more by visiting www.scdfc.org.

About the U.S. Food and Drug Administration

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetic, dietary supplements, products that give off electronic radiation, and regulating tobacco products. Learn more about the FDA Center for Devices and Radiological Health by visiting https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health.

Fonte: Business Wire

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