System Wide Operations for Rare Disorders (SWORD)

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PROJECT SUMMARY/ABSTRACT Title: System Wide Operations for Rare Disorders (SWORD) Understanding and developing new treatments for human rare disorders presents many challenges. The fact that they are so rare means that patients who could participate in Rare Diseases Clinical Research Network (RDCRN) and other studies do not participate due to a limited number of sites for each study and the distance the patient would have to travel to reach one of these sites. One good thing that has come from the COVID-19 pandemic is the general acceptance that both clinical care and research studies can be performed remotely through telehealth and mailing records and documents to a distant site. While many components of a research study or clinical trial can be conducted remotely, some aspects require actual person- to-person contact. One of these components is blood draws, process, and shipment to core study laboratory following study protocols. Major barriers to blood draws for biomarker studies include the lengthy process of both IRB oversight and reimbursements to institutions that make it highly impractical to set up a site for a handful of patients closer to where they reside. As a means to solve this problem for our BVMC6211 project, here we propose the development of ‘SWORD: A network of all CTSA programs capable of drawing and processing blood samples to act as a patient portal for rare disorder studies and trials. SWORD stands for “System Wide Operations for Rare Disorders”. This proposal will leverage our BVMC 6211 study and for dissemination our partnership with the “Sturge Weber Foundation” (SWF) to disseminate SWORD and address challenges with blood draws, processing, and shipping to core lab as per study protocol for NIH funded multi-sites studies. The overall goal of SWORD is to develop and disseminate an efficient way to enhance enrollment in studies requiring phlebotomy and specimen processing and shipping for patients participating in RDRCN studies who live far from enrollment sites. Success with SWORD for blood draws could quickly expand to other services including radiology and for obtaining other biological specimens.