Biotech Values

[poorgradstudent]

That's weird. Any discussion about why they did that? Seems like it potentially could easily create some sort of bias.

The presenter mentioned that they wanted to give the audience a more direct idea of the drug's performance rather than potentially confounding it with the effect of the treatment that a patient may have moved onto.

In a single arm trial, I don't think that's the worst idea insofar as the impact of follow-up treatment is taken out of the equation. Whether follow-up treatments could make a tangible impact on a database of 200+ patients is debatable. But there's not much of a downside that I can think of simply because they can always present the more traditional analysis if people want it. If anything, this way of presentation shortens the perceived durations (which are not marginal imo) so I think the attempt is genuine rather than opportunistic.

Off the top of my head I'm thinking that potential bias would be more likely in a trial with a comparator arm. In a disease like myeloma where you have many patients actually moving onto other treatments, there is a chance that sequential administration of investigational drug X followed by other conventional treatment makes things worse. Censoring that post-trial effect may allow unscrupulous management teams to massage the message they send to investors, especially when they have a comparator arm that presents a "bar" for them to surpass.

I do see it cutting both ways, but in this case it appears to me to be the case of a biotech with good data trying their best to challenge the competitors and/or set a high bar for comparisons.