With Louise Campbell and Jörn Schattenberg both on Easter Week vacations, Fatty Liver Alliance Founder Mike Betel joins Roger Green to continue a brief conversation they began in a post from the Fatty Liver Alliance last weekend. This conversation focuses largely on how patient incentives to participate in MASH clinical trials might need to change now that Rezdiffra is approved.
00:00:00 - Introduction
Roger explains why Louise and Jörn are not available for this conversation and welcomes Mike to a dialogue on issues they are considering in the aftermath of Liver Forum 16.
00:01:22 - The importance of convergence
Mike elaborates slightly on a comment he made in a Friday FattyLiver/SurfingMASH post on LinkedIn about the importance of thoughtful convergence between all the stakeholder groups to identify and resolve issues and why he considers the Liver Forum a great place to do this. Roger shares his understanding of the unifying challenge underlying the Forum's remit and the issue it chooses to address.
00:03:15 - Including patients in clinical trial design
Roger asks Mike what role he believes patient advocates should play in clinical trial design and bringing regulatory issues forward. Mike elaborates on the importance of including patients in clinical trial design.
00:04:47 - Three issues to consider around placebo, biopsy and clinical trials
Roger lists three issues he considers critical to consider in the aftermath of having an approved drug for advanced MASH patients: (i) requiring biopsies for trial when they are not required for treatment; (ii) willingness of patients to participate in trials when the Control group option remains placebo despite an approved drug; and (iii) maintaining trial patients on placebo to the end of Phase 4.
00:05:20 - Keeping placebo patients in clinical trials
To Mike, a key challenge for BioPharma companies will be what to offer placebo patients when they finish a clinical trial or the trial transitions to Phase 4. Roger suggests the challenge will become easier in future trials once a Standard of Care replaces placebo in the control group.
The conversation meanders through the various issues related to placebo in terms of trial assignment and continuation in Phase 4.
00:09:19 - The benefit of having the Liver Forum
To Mike, the Liver Forum brings tremendous benefit in terms of providing a forum for all stakeholders to consider these issues together. Roger points to a different benefit: the ability of companies to pool resources in situations where the cost might be too much for one company to assume. He cites the example of the Placebo Arm Database Project (discussed in Season 3 Episode 57).
00:10:52—Is the performance of a placebo group in clinical trials the same as that of untreated patients worldwide?
Mike asks whether study results for patients in the placebo control arm of a clinical trial are similar to results we would find in the practice of medicine outside the trial setting. Roger remembers an early lipids trial in which the effect of counseling overwhelmed drug impact. They discuss how complicated (if not impossible) it would be to design a trial that accurately compares the effect of a "standard treatment" group to the trial control and active groups.
00:13:28 - Can we ensure that patients in general practice get the same level of support as patients in a clinical trial?
Mike suggests that a multi-stakeholder event like the Forum should address ways to ensure that patients in everyday practice get the same support as patients in clinical trials. Roger suggests this goal may be unachievable given the limited amount of time primary care physicians can devote to a typical patient visit.
00:15:32 - Signoff
After a brief signoff, the conversation ends.
With Louise Campbell and Jörn Schattenberg both on Easter Week vacations, Fatty Liver Alliance Founder Mike Betel joins Roger Green to continue a brief conversation they began in a post from the Fatty Liver Alliance last weekend. This conversation focuses largely on how patient incentives to participate in MASH clinical trials might need to change now that Rezdiffra is approved.
00:00:00 - Introduction
Roger explains why Louise and Jörn are not available for this conversation and welcomes Mike to a dialogue on issues they are considering in the aftermath of Liver Forum 16.
00:01:22 - The importance of convergence
Mike elaborates slightly on a comment he made in a Friday FattyLiver/SurfingMASH post on LinkedIn about the importance of thoughtful convergence between all the stakeholder groups to identify and resolve issues and why he considers the Liver Forum a great place to do this. Roger shares his understanding of the unifying challenge underlying the Forum's remit and the issue it chooses to address.
00:03:15 - Including patients in clinical trial design
Roger asks Mike what role he believes patient advocates should play in clinical trial design and bringing regulatory issues forward. Mike elaborates on the importance of including patients in clinical trial design.
00:04:47 - Three issues to consider around placebo, biopsy and clinical trials
Roger lists three issues he considers critical to consider in the aftermath of having an approved drug for advanced MASH patients: (i) requiring biopsies for trial when they are not required for treatment; (ii) willingness of patients to participate in trials when the Control group option remains placebo despite an approved drug; and (iii) maintaining trial patients on placebo to the end of Phase 4.
00:05:20 - Keeping placebo patients in clinical trials
To Mike, a key challenge for BioPharma companies will be what to offer placebo patients when they finish a clinical trial or the trial transitions to Phase 4. Roger suggests the challenge will become easier in future trials once a Standard of Care replaces placebo in the control group.
The conversation meanders through the various issues related to placebo in terms of trial assignment and continuation in Phase 4.
00:09:19 - The benefit of having the Liver Forum
To Mike, the Liver Forum brings tremendous benefit in terms of providing a forum for all stakeholders to consider these issues together. Roger points to a different benefit: the ability of companies to pool resources in situations where the cost might be too much for one company to assume. He cites the example of the Placebo Arm Database Project (discussed in Season 3 Episode 57).
00:10:52—Is the performance of a placebo group in clinical trials the same as that of untreated patients worldwide?
Mike asks whether study results for patients in the placebo control arm of a clinical trial are similar to results we would find in the practice of medicine outside the trial setting. Roger remembers an early lipids trial in which the effect of counseling overwhelmed drug impact. They discuss how complicated (if not impossible) it would be to design a trial that accurately compares the effect of a "standard treatment" group to the trial control and active groups.
00:13:28 - Can we ensure that patients in general practice get the same level of support as patients in a clinical trial?
Mike suggests that a multi-stakeholder event like the Forum should address ways to ensure that patients in everyday practice get the same support as patients in clinical trials. Roger suggests this goal may be unachievable given the limited amount of time primary care physicians can devote to a typical patient visit.
00:15:32 - Signoff
After a brief signoff, the conversation ends.