S4-36.2 – LOCATE-NAFLD: Study Design and Early Analysis

S4-36.2 - LOCATE-NAFLD: Study Design and Early Analysis
New guest, Prof. James O’Breine, joins Naim Alkhouri, Louise Campbell and Roger Green to discuss improving models for patient identification and risk stratification with the LOCATE-NAFLD project. This conversation features general comments and questions around the study design before James shares two interesting pieces of data from early analysis.

Co-hosts Louise Campbell and Roger Green are joined by friend of the podcast, Naim Alkhouri, and new guest, Professor James O’Beirne, to discuss learning from liver disease in Australia and developing improved models for patient identification and risk stratification.

This conversation proceeds from a high-level overview of the LOCATE-NAFLD study. Discussion opens to comments from the panelists, starting with Naim commending the basic idea of a randomized study and the sample size for this initiative. He goes on to ruminate on how effective this design will be at correctly assessing positive and negative predictive values. James describes some of the funding and regulatory issues that shaped the design. As the conversation continues, it becomes clear that the median times to referral in the intervention and control groups were dramatically different and that these differences will have real clinical impact in a world with approved NASH agents. Louise raises the point that this kind of model can speed access to trial tremendously. James shares ideas around what motivated patients to enroll in the study and explains that significant numbers of patients screened out, most often due to high levels of alcohol consumption. As the conversation winds down, James mentions two interesting pieces of data from early analysis: a significant and clinically meaningful differences between successful FibroScan reads in the two groups and, separately, the lack of separation between the groups in quality of life scores.

If you have questions or comments around the LOCATE-NAFLD study or any other ideas addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.

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