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Overcoming barriers in the design and implementation of clinical trials for Acute Kidney Injury: a report from the 2020 Kidney Disease Clinical Trialists meeting

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  • معلومة اضافية
    • Contributors:
      University of California San Francisco (UC San Francisco); University of California (UC); University of California San Diego (UC San Diego); Perelman School of Medicine; University of Pennsylvania; AM-Pharma; Case Western Reserve University Cleveland; Cleveland Clinic; Bayer Pharmaceuticals; University of Michigan Ann Arbor; University of Michigan System; Johns Hopkins University School of Medicine Baltimore; Verpora Ltd; National Institute of Diabetes and Digestive and Kidney Diseases Bethesda; Division of Chronic Care Management, Centers for Medicare & Medicaid Services; University of Washington Seattle; Défaillance Cardiovasculaire Aiguë et Chronique (DCAC); Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL); Centre d'investigation clinique plurithématique Pierre Drouin Nancy (CIC-P); Centre d'investigation clinique Nancy (CIC); Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL); Cardiovascular and Renal Clinical Trialists Vandoeuvre-les-Nancy (INI-CRCT); Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu Nancy; French-Clinical Research Infrastructure Network - F-CRIN Paris (Cardiovascular & Renal Clinical Trialists - CRCT )
    • بيانات النشر:
      HAL CCSD
      Oxford University Press
    • الموضوع:
      2022
    • Collection:
      Université de Lorraine: HAL
    • نبذة مختصرة :
      International audience ; Abstract Acute Kidney Injury (AKI) is a growing epidemic and is independently associated with increased risk of death, chronic kidney disease, and cardiovascular events. Randomized-controlled trials (RCTs) in this domain are notoriously challenging, and many clinical studies in AKI have yielded inconclusive findings. Underlying this conundrum is the inherent heterogeneity of AKI in its etiology, presentation, and course. AKI is best understood as a syndrome, and identification of AKI subphenotypes is needed to elucidate the disease's myriad etiologies and tailor effective prevention and treatment strategies. Conventional RCTs are logistically cumbersome and often feature highly selected patient populations that limit external generalizability, and thus alternative trial designs should be considered when appropriate. In this narrative review of recent developments in AKI trials based on the Kidney Disease Clinical Trialists (KDCT) 2020 meeting, we discuss barriers to and strategies for improved design and implementation of clinical trials for AKI patients, including predictive and prognostic enrichment techniques, the use of pragmatic trials, and adaptive trials.
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/35022767; hal-03586738; https://hal.univ-lorraine.fr/hal-03586738; https://hal.univ-lorraine.fr/hal-03586738/document; https://hal.univ-lorraine.fr/hal-03586738/file/KDCT%20Manuscript.pdf; PUBMED: 35022767
    • الرقم المعرف:
      10.1093/ndt/gfac003
    • Rights:
      info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.49C2305A