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eagle8

07/16/16 11:08 AM

#66947 RE: Dan88 #66944


Great post Dan88 !

Thanks.

GLTU
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exwannabe

07/16/16 11:25 AM

#66949 RE: Dan88 #66944

The company developing DCVax-L, after observing unusually low evening rate of all patients in the trial as a whole, has voluntarily stopped enrolling any new patient candidates some ten months ago because it doesn't want to enroll any patients into the control arm as it is highly likely DCVax-L works;


So because they think DCVax works they will stop allowing patients to enrol in a trial which is the only way to get the agent; either by luck, post progression or expanded access. In you example, LP just blocked any ability for my wife to get DCVax-L.

Does that not sound a bit backwards?

Most other trials when they see clear evidence of a drug working halt the trial and allow everybody to cross over to treatment. Sometimes they even immediately launch an open expanded access that allows all to get the drug while it awaits approval. That is ethical.






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pgsd

07/16/16 11:36 AM

#66951 RE: Dan88 #66944

Thank you for your insight, very enjoyable reading
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foxhound02

07/16/16 11:53 AM

#66954 RE: Dan88 #66944

"Yes, it could also turn out that there might be no ss difference between the control and treatment arms (or early and late DCVax-L receiving patients) but the fact is "any patient enrolled in the trial lives longer, much longer than anticipated. This observation is based on updated 20 months or so anticipated median OS for this deadly indication. So to call it unusual, the median OS for the entire trial must be well over 25 months or even higher.

So do you think the company will risk being sued later by you, let alone it is unethical for the company, for knowingly putting your wife/husband with risks being put into the control arm to receive inferior treatment?"

This post is getting high fives, but there are some problems. Take for example the contradiction in the above statement. The author suggests that there may be not be a difference between control and treatment arms (early vs late DC), then says in the next paragraph that being in the control arm would be unethical and the control is inferior??????????

The post goes on to suggest the halt was due to knowledge that control is inferior. This means the company lied in stating that the halt was due to problems with enrollment criteria. The board has gotten completely astray from the facts concerning why there was a halt and shifted to a narrative that somehow it is related to a super secret approval going on in the background.