We work to keep every patient engaged to the end, from risk retention matrix and personal contact with CRAs, to patient-facing animation in 20 languages.
Clinical trials for rare diseases pose specific challenges due to their elusive nature and low patient populations. Research is critical for these often serious and even life-threatening diseases that also affect pediatric patients and generally have no known cures. When studies are done, retention of patients in these relatively small trials is of utmost importance and must include strong patient knowledge and communication.
George Clinical is working on two interventional kidney clinical trials now in progress: one that seeks to help patients with focal segmental glomerulosclerosis (FSGS) and another that is one of the largest studies to date in IgA nephropathy (IgAN). Both are Phase III global studies that span several years and several hundred patients each.
FSGS can have many different causes. It is a leading cause of end-stage renal disease (ESRD) in children, although it occurs more frequently in adults. Trials are critical as there is currently no FDA-approved treatment.
IgAN is an autoimmune disease that results in the development of ESRD in 10%–20% of patients occurring most frequently in Caucasian and Asian populations and almost twice as common in males. Typically, it affects young and middle-aged adults. There is no cure and no way to determine what course it will take in any given individual. Therapies are currently targeted at slowing its progress, but some treatments, such as high-dosage corticosteroid therapy, pose a risk of toxicity, and KDIGO guidelines suggest that this should “…be given with extreme caution or avoided entirely in certain situations.” (KDIGO 2021 Clinical Practice Guideline For the Management of Glomerular Diseases. Kidney Int Suppl 2021).
“Our retention team ensures that every patient is tracked and followed up, and that the Medical Monitor and CRAs are giving the study site the right support they need in order to achieve the best outcome with the patient. We are also constantly monitoring for potential risks that are not yet known to the study team. If we detect a potential red flag from our risk monitoring reports (based on significant disease specific elements as well as patient centered elements), George Clinical contacts the CRA to have them check in with the site and determine the best course of intervention to retain that patient in the study.” Sarah Coggan, Global Scientific Manager, George Clinical.
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