Platform trial starting

Nikki J

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This has been in the works for a while. Platform trials have been used in cancer. There are multiple arms testing different therapies. Each arm “ contributes” to the placebo group The result is that although the analysis for each trial arm will have 50/50 placebo/ treatment all the participants have a much higher chance of receiving the treatment drug. The system is also overall cheaper and faster

 

affected

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I'm trying to get my head around that one Nikki, help me out?
If each trial arm will have 50/50 placebo/treatment ratio, how does that mean all participants have a much higher chance of receiving the treatment drug? Probably should have had coffee before reading this, and I didn't follow the link to read more.
 

Nikki J

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Because the trial uses the same measures they can share the placebo data. So in a sense, each arm contributes a certain number of placebo spots so group one has the people getting the real drug, their placebo people plus the placebo people from other groups. A( treated people) = B (group one placebo people) plus an equal number of placebo people from each group. The more groups the higher the percentage of people not getting placebo in any given group They are starting with three arms and going quickly to five.

There is also the possibility if one arm is stopped because of lack of efficacy or another reason of being reassigned to another arm
 

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thanks brains trust 🤗
 

plcare

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Dr. Cudkowicz, from MGH, spoke at the Florida ALSA Hope and Help symposium this past weekend, and addressed this new trial platform in detail. There is also an in depth webinar on the ALS TDI website that explains exactly how this approach should help expedite clinical trials.
 

nona

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Nikki, have you heard about requirements or restrictions on participation?
 

Nikki J

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I have not. Dr Cudkowicz did say that theoretically different arms could have somewhat different criteria depending on the drug target/ mechanism of action. If I remember correctly she gave examples of genetic mutations and inflammation. This was long before the starting drugs were selected so it was theoretical only. However, I do think that other than that the criteria will be the same for all arms and I rather expect similar to what we have seen before

Did you listen to her NEALS webinar this summer. It is archived if you did not. As well as talking about this I seem to remember she talked about expanded access ( not for this trial in particular)

The trial hasn’t posted yet. When I see it I will add to this thread
 

Gorby

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