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S3-E28.2 – #NASHDay 2022 Preview: What New Approaches To Clinical Trial Design Will Mean For Our Community

Jörn Schattenberg, Louise Campbell and Roger Green react to Stephen Harrison's description of major advances in Phase 3 clinical trial design (in Episode 28.1)

About Clinical Trial Design & NASHDay

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.

This conversation consists mostly of reactions from Jörn Schattenberg, Louise Campbell and Roger Green to Stephen’s initial statement, followed by other thoughts from Stephen. The other Surfers are all impressed by the trial design. In response to a comment from Roger, Stephen comments enthusiastically on the unprecedented collaboration between sponsors, academics, regulators – the entire range of stakeholders – to resolve this issue. He goes on to note other questions – for example, the name of the disease – where the community is demonstrating unparalleled collaboration. All of this, he says, is leading to a proliferation of new research so vast that no one can keep up with all of it.

There are three more points in this conversation:

  • Jörn raises Quentin Anstee’s comments from Episode 26 that we need to develop a standard set of NITs to use in the evaluation process as another area where collaboration will be key
  • Stephen points out that we may see our first drug approval in 2023, which will add new levels of energy and resourcing to the development and education processes
  • Jörn begins to discuss his issue, which is the convergence between conferences to cover a range of issues that look past simple drug development to improve key questions from drug evaluation to clinical care pathways and inter-specialty collaboration to treat patients
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