First patient dosed in part II MDS study

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Posts: 17
Joined: Mon Oct 08, 2018 12:19 pm

Re: First patient dosed in part II MDS study

Post by Zhears » Wed Oct 16, 2019 2:10 pm

Great news.

Still can't get my head around how they can take so long to recruit patients when there is 70 sites involved,

Is it normal for some sites in a trail to not actually recruit? Or only have few people involved over the entire trail length?

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Re: First patient dosed in part II MDS study

Post by biopearl123 » Wed Oct 16, 2019 7:28 pm

Zhears, I have to agree, its it taking a long time. I estimate we lost an entire year given Janssen's decision. They could have just started part II, tacked on to part I almost exactly one year ago. To your point specifically however, you would think patients would be lined up to enroll, even if 1/3 knew they would get placebo (perhaps the protocol allows for crossover to therapy after clear non response but I doubt it.) In any case it could be that there are stringent enrollment criterion that must be met. Each site need only contribute 2-3 patients for the study to fully enroll and many sites such as Columbia, Mayo etc clearly have many more patients they could enroll. I do think Geron will encourage having as many active sites as possible so as to avoid any criticism re bias in patient selection from a statistical standpoint. This comes at a cost in efficiency since 10 sites enrolling 17 patients each would be a lot easier to manage. Also there could be a strategy to identify patients that can receive drug as soon as it is approved (read paying patients in the chute) that might not actually enroll in the study but get drugs early post approval. That's the best I can do, all other thoughts appreciated. bp

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