Biomedical Research Core 4: Clinical Research Core

University Of Kansas Medical Center, Kansas City KS

Investigators

Linked publications & trials

Abstract

Project Abstract Biomedical Research Core 4: Clinical Research Core (Core Director: Alan Yu) The long-term goal of the Clinical Research Core is to facilitate clinical and translational research in PKD, with a focus on investigator-initiated studies that bridge the gap between preclinical studies and early phase clinical trials. This will be achieved through the provision of consultative advice on drug development, a patient registry network for clinical trials recruitment, resources and services for conducting clinical trials, and a searchable integrated clinical data repository for observational research. Aim 1 of the Core will provide consultative services for drug discovery and development projects. For this aim, a group of experts in drug development, preclinical testing and clinical care of PKD patients will provide consultative advice on development of PKD therapeutics starting with the identification of a candidate molecule and with the endpoint being a first-in-human clinical trial. Aim 2 of the Core will develop a searchable registry of PKD patient volunteers for clinical trials recruitment. The Core will build a registry of patients willing to be contacted for clinical trials recruitment. This will greatly facilitate assessment of feasibility of trials, development of research protocols, and will enable rapid start-up once a trial is activated. Aim 3 of the Core will provide services and resources to conduct clinical trials. The Core will provide a one-stop shop where all the resources needed to conduct a PKD clinical trial will be provided including clinic rooms, research coordinators, clinical and research laboratory testing, nutritional advice, and guidance with trial design. Aim 4 will build a user-friendly, data-rich observational PKD cohort database. The Core will create an observational database from the entire cohort of patients with PKD that is followed at KUMC. Data from their electronic health records and other sources are imported into the Healthcare Enterprise Repository for Ontological Narration (HERON), an i2b2-based platform. Users will be able to interrogate de-identified data including demographics, diagnoses, laboratory results, medication data, procedures, and nursing observations in order to conduct outcomes research.