S3-E57.4 - Discussing Critical Success Factors for Placebo Cohorts

Send us Fan MailThe Liver Forum aims to advance the regulatory sciences for the treatment of NAFLD/NASH and liver fibrosis by providing a neutral, independent venue for ongoing multi-stakeholder dialogue. Their work facilitates the best science-based decisions on how to study efficacy and safety in real-time by using collective knowledge and experience with therapies for advancing liver disease. In this final conversation, Executive Director Veronica Miller joins guest Manal Abdelmalek and co-host Jörn Schattenberg (both Steering Committee members) to discuss the Liver Forum, its unique processes and valuable work. Roger Green starts this conversation suggesting that the findings of the Placebo Arm Database Project need to translate into guidelines for researchers to formally standardize. Veronica describes elements of how the Forum is organizing the trial and what she considers some of the critical success factors for a placebo cohort. She notes this should benefit individual pharmaceutical sponsors because they can assess data in the context of placebo response and how to recruit patients for clinical trials. She also believes that if these metrics are feasible to implement, they will find ways into clinical practice as well. Manal notes that another benefit might be to give regulators access to larger data sets that mirror how the trials are done, leveraging resources and providing benchmarks at the same time. Jörn notes the Forum to be an open process and provides examples of what he considers to be some key benefits to this. Veronica concludes the main conversation by discussing the idea that a shared placebo arm might be possible and would have tremendous benefit. Roger poses the final question: each panelist provides the strongest takeaway for what they hope listeners glean from this episode. Surf on to find out more.