S3-E28.1 – #NASHDay 2022 Preview: New Approaches To Clinical Trial Design

S3-E28.1 - #NASHDay 2022 Preview: New Approaches To Clinical Trial Design
In this #NASHDAY 2022 Preview conversation, Stephen Harrison discusses new approaches to Phase 3 clinical trial design and endpoint evaluation, changes he describes as "real, granular progress in drug development."

Thursday, June 9, marked #NASHDay 2022, the 5th annual celebration of International NASH Day by the world’s largest liver patient advocacy organization, the Global Liver Institute. To celebrate the occasion, Stephen Harrison joined Jörn Schattenberg, Louise Campbell and Roger Green to celebrate the event and comment on one crucial trend or event most signified what the last year has meant in the Fatty Liver community.

Roger’s first question was for each panelist to describe a major event that took place since the 4th International NASH Day last June. Stephen Harrison answers first by discussing major advances in clinical trial design. This conversation consists of his answer.

Stephen Harrison describes two related areas where we have made what he describes as “real, granular progress in drug development” in terms of rethinking the design of Phase 3 clinical trials and endpoint assessment related to this redesign. Historically, sponsors conducted a single, very large, very long trial that sought first to achieve conditional approval based on sub-part H endpoints in fibrosis and then to achieve full approval based on outcomes developed as the initial trial group progresses to cirrhosis. The new idea is to conduct the fibrosis and cirrhosis elements in parallel, thus shortening the time to approval, simplifying endpoints and reducing the cost of the overall trial process. It is a vision of breathtaking scope…and, Stephen reports, it’s almost ready to launch.

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