Presentation (Project) Title

Demographic Analysis: Evaluation Amongst Clinical Trial Screen Fail (CTSF) Patients in a Large Clinical Research Center

Mentor Information

Guy W. Neff (Department of Hepatology)

Presentation Format

Event

Abstract

Introduction: There has been an increase in the prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) worldwide. NAFLD is pathologically divided into disease state without inflammation called Non-Alcoholic Fatty Liver (NAFL) and disease state with inflammation is called Non-Alcoholic Steatohepatitis (NASH). The uncertain picture of the archetypal NAFLD patient poses a challenge in isolating at-risk patients and identifying endemic populations. Currently, there are no FDA-approved treatments for NASH. The most promising treatment for NAFLD is in the direction of NAFLD clinical trials. However, the rates of screen failures are generally greater than that of randomization. The study’s objective is to analyze the demographics of patients who do not meet inclusion/exclusion criteria for NAFLD clinical trials. This aims to improve patient identification for NAFLD trials to reduce screen failures and accelerate enrollment. Methods: Patient information of 158 patients who screen failed for NAFLD clinical trials were retrospectively analyzed. Data collected includes the following demographic information: sex, age, ethnicity, and race. We analyzed the various groups frequency of CTSF. Results: The data collected reveals white, non-Hispanic, greater than 50 years of age have the highest risk for CTSF rate. Black and Asian subjects were under-represented within the analysis. Conclusion: The above data demonstrates differences in CTSF rates amongst ethnicity, gender, and age. Understanding the patient population that screen failed will optimize the recruitment and screening process for NALFD trials.

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Demographic Analysis: Evaluation Amongst Clinical Trial Screen Fail (CTSF) Patients in a Large Clinical Research Center

Introduction: There has been an increase in the prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) worldwide. NAFLD is pathologically divided into disease state without inflammation called Non-Alcoholic Fatty Liver (NAFL) and disease state with inflammation is called Non-Alcoholic Steatohepatitis (NASH). The uncertain picture of the archetypal NAFLD patient poses a challenge in isolating at-risk patients and identifying endemic populations. Currently, there are no FDA-approved treatments for NASH. The most promising treatment for NAFLD is in the direction of NAFLD clinical trials. However, the rates of screen failures are generally greater than that of randomization. The study’s objective is to analyze the demographics of patients who do not meet inclusion/exclusion criteria for NAFLD clinical trials. This aims to improve patient identification for NAFLD trials to reduce screen failures and accelerate enrollment. Methods: Patient information of 158 patients who screen failed for NAFLD clinical trials were retrospectively analyzed. Data collected includes the following demographic information: sex, age, ethnicity, and race. We analyzed the various groups frequency of CTSF. Results: The data collected reveals white, non-Hispanic, greater than 50 years of age have the highest risk for CTSF rate. Black and Asian subjects were under-represented within the analysis. Conclusion: The above data demonstrates differences in CTSF rates amongst ethnicity, gender, and age. Understanding the patient population that screen failed will optimize the recruitment and screening process for NALFD trials.