Evaluation researchers at Clinical and Translational Science Award (CTSA) hubs are conducting retrospective case studies to evaluate the translational research process. The objective of this study was to deepen knowledge of the translational process and identify contributors to successful translation. We investigated the successful translation of the HemeChip, a low-cost point-of-care diagnostic device for sickle cell disease, using a protocol for retrospective translational science case studies of health interventions developed by evaluators at the National Health Institutes (NIH) and CTSA hubs. Development of the HemeChip began in 2013 and evidence of device use and impact on public health is growing. Data collection methods included five interviews and a review of press, publications, patents, and grants. Barriers to translation included proving novelty, manufacturing costs, fundraising, and academic-industry relations. Facilitators to translation were CTSA pilot program funding, university resources, entrepreneurship training, due diligence, and collaborations. The barriers to translation, how they were overcome, and the key facilitators identified in this case study pinpoint areas for consideration in future funding mechanisms and the infrastructure required to enable successful translation.
retrospective case studies, sickle cell disease, successful translation, CTSA, pilot program, point-of-care diagnostics
Journal of Clinical and Translational Science
U54HL119810; R21TW010610; R44HL140739; R41HL151015; R41DK119048; R01HL133574
Case Coulter Translational Research Partnership; NIH Center for Accelerated Innovation at Cleveland Clinic; Ohio Third Frontier Technology Validation and Start-up Fund; Consortia for Improving Medicine with Innovation & Technology (CIMIT); Fogarty International Center, National Institutes of Health (NIH); Vodafone Americas Foundation Wireless Innovation Project; National Heart Lung and Blood Institute Small Business Innovation Research Program; National Institute of Diabetes and Digestive and Kidney Diseases Small Business Innovation Research Program; National Heart Lung and Blood Institute
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Qua, Kelli; Swiatkowski, Shannon M.; Gurkan, Umut A.; and Pelfrey, Clara M., "A Retrospective Case Study of Successful Translational Research: Gazelle Hb Variant Point-of-Care Diagnostic Device for Sickle Cell Disease" (2021). Faculty Scholarship. 80.