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Thread: ChinaSCINet Update

  1. #331

  2. #332
    Dr.Wise, now is June 11th.How is going with the trial in KunMing?

  3. #333
    Quote Originally Posted by y8225009 View Post
    Dr.Wise, now is June 11th.How is going with the trial in KunMing?
    Dr Young posted this in another thread this morning-

    I am heading to China this week to see if we can kick off the trial in Kunming where the patients have been recruited and the paperwork is more or less completed. I hope that this will move things along.

  4. #334
    Thank you Dr. Young, for continuing to give us hope.

  5. #335
    Senior Member
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    Good luck on your trip and thank you.

  6. #336
    I was thinking about something last night and thought to ask D.R Young about it. My question is: what makes a good trial successful or not? As in, you are currently conducting phase 2 trial on your promising therapy, and so how would you know if you should move on to phase 3 or not. What if only 25% of the people that undergone your therapy only had a 25% functional, sensory,bb, or sexual improvement? Would that be considered successful? If your phase 3 trial brought about these results, would it be provided to the public? Because I think that that would be just fine under the circumstances.

    So I was just thinking about the thought process from a researchers point of view.

  7. #337
    Senior Member KIM's Avatar
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    1% is good enough.

  8. #338
    Quote Originally Posted by sam i am View Post
    I was thinking about something last night and thought to ask D.R Young about it. My question is: what makes a good trial successful or not? As in, you are currently conducting phase 2 trial on your promising therapy, and so how would you know if you should move on to phase 3 or not. What if only 25% of the people that undergone your therapy only had a 25% functional, sensory,bb, or sexual improvement? Would that be considered successful? If your phase 3 trial brought about these results, would it be provided to the public? Because I think that that would be just fine under the circumstances.

    So I was just thinking about the thought process from a researchers point of view.
    sam,

    The decision to go ahead depends on the findings.

    1. If the phase 2 treatment shows that the treatment causes complications or is not effective, then you stop or change the procedure and retest in another phase 2 trial.

    2. Because phase 2 studies are typically not powered sufficiently (i.e. don't have enough patients to achieve statistical significance), the decision whether to proceed to a phase 3 depends on the results. The results may fall into three categories:
    • The therapy has no beneficial effects or even a deleterious effect that cannot be attributed to some problem with dose or delivery. In such a case, one would clearly not proceed.
    • The therapy has clear beneficial effects that are statistically significant even at phase 2 levels. In such a case, one would proceed to phase 3 but with fewer patients in the trials because the results should be robust.
    • The therapy is safe and there is a trend for benefit. In such a case, one would go ahead with the phase 3, probably with more patients in the trials in case the results occur only in a fraction of the patients or the effects are small.

    3. If the phase 3 trial shows that umbilical cord blood cells are significantly beneficial, then all subsequent therapies will be compared against that treatment because it would be the first and best therapy that restores function to chronic spinal cord injury.

    Wise.

  9. #339
    Dr. Young, will there be any preliminary result reports this summer? No pressure.

  10. #340
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    Quote Originally Posted by Wise Young View Post
    sam,

    The decision to go ahead depends on the findings.

    1. If the phase 2 treatment shows that the treatment causes complications or is not effective, then you stop or change the procedure and retest in another phase 2 trial.

    2. Because phase 2 studies are typically not powered sufficiently (i.e. don't have enough patients to achieve statistical significance), the decision whether to proceed to a phase 3 depends on the results. The results may fall into three categories:
    • The therapy has no beneficial effects or even a deleterious effect that cannot be attributed to some problem with dose or delivery. In such a case, one would clearly not proceed.
    • The therapy has clear beneficial effects that are statistically significant even at phase 2 levels. In such a case, one would proceed to phase 3 but with fewer patients in the trials because the results should be robust.
    • The therapy is safe and there is a trend for benefit. In such a case, one would go ahead with the phase 3, probably with more patients in the trials in case the results occur only in a fraction of the patients or the effects are small.

    3. If the phase 3 trial shows that umbilical cord blood cells are significantly beneficial, then all subsequent therapies will be compared against that treatment because it would be the first and best therapy that restores function to chronic spinal cord injury.

    Wise.
    Norway, supports these visions, are glad to be a partner in trying to find curative treatments on SCI and are working on visionary, infrastructure for SCI users, with neuroscientists, clinicians, mri interventionists and neurosurgeons - to lift these ideas further and further regardless of conservative obstacles, for SCI possible cures. These are facts.

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