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Stop the trial and put all patients on CPUULSE they don't need...

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pigofsteel

10,009 Posts.

18/03/15

14:32

Post #: 14935625
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Originally posted by xc_mse ↑

Two things to consider
1) Risk Reward for patient
A patient will take on C-Pulse if they have a 25 % chance of doing really well on the up side matching a 25% chance of only getting relief of symptoms on the down side ie dieing soon within 18 months.
Add in control arm and patient has only a 12% chance of doing really well, and a 50% chance of firing soon.
A patient because the control arm prognosis is so bad will only enter the study in general to further medical science, a hard sell.

2) Data supplied to FDA
FDA has approved Interim analysis and moved it foward ( I think) because of the very high rate of deaths and generally abysmal patient comfort in the control arm.
The data supplied for the current IDE, one would think, would be for both the control and implant arm.
There is a very real possibility that deaths in the control arm are twice or more than that of the treatment arm.
I would expect a scenario like this.
If the FDA are worried about 4 deaths why aren't they worried about 6? Maybe 8 maybe 10 maybe 12 deaths.
Granting interim analysis early says they are very concerned.
What are their policy options?

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Stop the trial and put all patients on CPUULSE they don't need data on SOC HF..,

Approve C-PULSE with posts approval data...

SHC Price at posting: 2.5¢ Sentiment: Hold Disclosure: Held
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0 Great analysis

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