A Retrospective Analysis of Morbidity Variances Amongst Clinical Trial Screen Fail (CTSF) Patients from a Private Clinical Research Center
Mentor Information
Guy W. Neff (Department of Hepatology)
Description
Introduction: Non-alcoholic fatty liver disease (NAFLD) is a rapidly growing global disease state. Nonalcoholic Steatohepatitis (NASH) is the progressive form of NAFLD, whereupon a fatty inflammatory process leads to liver damage. NASH disease state is the second most active research disease state and offers patients a treatment option. To enter a clinical trial, subjects undergo a screening process that includes three steps: laboratory analysis, MRI sequence analysis, and liver biopsy for definitive diagnosis of NASH. The clinical trial screen fail (CTSF) rate for NASH trials is extremely high and often greater than 75%. The aim of this project is to analyze a cross-sectional cohort experiencing CTSF for current NASH trials. Methods: A retrospective review of medical records was completed that included data patients who were prescreened and screened for NASH clinical trials. The data included the following: potential NASH/NAFL related morbidities, controlled attenuation parameter (CAP) scores, liver stiffness measurement (kPa), MRI-PDFF values and various lab values. Results: The results demonstrate that morbidities including diabetes, obesity, and hypertension have a higher CTSF rate when compared to subjects with diabetes and obesity or hypertension. The data suggests that DM-II and vast number of metabolic syndrome components should be emphasized when pre-selecting NAFLD patients for screening. Conclusions: The long-term analysis noted above will require further in-depth analysis to delineate the morbidities that identify the NASH population. This project will create guidance and direction of resources, reduce the cost of screening, and improve the overly high screen fail rate staggering fatty liver trials.
A Retrospective Analysis of Morbidity Variances Amongst Clinical Trial Screen Fail (CTSF) Patients from a Private Clinical Research Center
Introduction: Non-alcoholic fatty liver disease (NAFLD) is a rapidly growing global disease state. Nonalcoholic Steatohepatitis (NASH) is the progressive form of NAFLD, whereupon a fatty inflammatory process leads to liver damage. NASH disease state is the second most active research disease state and offers patients a treatment option. To enter a clinical trial, subjects undergo a screening process that includes three steps: laboratory analysis, MRI sequence analysis, and liver biopsy for definitive diagnosis of NASH. The clinical trial screen fail (CTSF) rate for NASH trials is extremely high and often greater than 75%. The aim of this project is to analyze a cross-sectional cohort experiencing CTSF for current NASH trials. Methods: A retrospective review of medical records was completed that included data patients who were prescreened and screened for NASH clinical trials. The data included the following: potential NASH/NAFL related morbidities, controlled attenuation parameter (CAP) scores, liver stiffness measurement (kPa), MRI-PDFF values and various lab values. Results: The results demonstrate that morbidities including diabetes, obesity, and hypertension have a higher CTSF rate when compared to subjects with diabetes and obesity or hypertension. The data suggests that DM-II and vast number of metabolic syndrome components should be emphasized when pre-selecting NAFLD patients for screening. Conclusions: The long-term analysis noted above will require further in-depth analysis to delineate the morbidities that identify the NASH population. This project will create guidance and direction of resources, reduce the cost of screening, and improve the overly high screen fail rate staggering fatty liver trials.
