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  • question for wise and community... Want opinions

    I consider myself to be against the current out-of-country Treatments. But even though, compared to some others, I haven't been paralyzed long (6 years): it's long to me.

    I can do almost nothing for myself.... My question is that, if I decided to have one of the Treatments, I have a real chance at gaining at least a little.
    What is the deal with participating in a US trial if you have already underwent a Treatment?
    Because if I could undergo an out-of-country country now and get something, and US trials won't be ready for years.... Whats to stop me from having an out-of-country Treatment now and a US Treatment when it FINALLY comes to "finish it up "?

    I know some of the coming trials won't accept you if you have had a previous Treatment at some time, like six months prior, but I don't see US trials coming anytime soon .

    I need some helpful insight guys
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  • #2
    Originally posted by lunasicc42 View Post
    I consider myself to be against the current out-of-country Treatments. But even though, compared to some others, I haven't been paralyzed long (6 years): it's long to me.

    I can do almost nothing for myself.... My question is that, if I decided to have one of the Treatments, I have a real chance at gaining at least a little.
    What is the deal with participating in a US trial if you have already underwent a Treatment?
    Because if I could undergo an out-of-country country now and get something, and US trials won't be ready for years.... Whats to stop me from having an out-of-country Treatment now and a US Treatment when it FINALLY comes to "finish it up "?

    I know some of the coming trials won't accept you if you have had a previous Treatment at some time, like six months prior, but I don't see US trials coming anytime soon .

    I need some helpful insight guys
    You should not take the SCINetUSA as exemplary of trials by others. While SCINetUSA may accept subjects who have participated in some other clinical trial more than 12 months ago (it is not 6 months), most others would not accept you if you had any kind of experimental therapy, especially cell transplants.

    The purpose of a clinical trial is not to "finish up". Most therapeutic clinical trials have one purpose and that is to determine the benefit:risk ratio of an experimental therapy so that other doctors would accept the therapy and apply the therapy to their patients, so that regulatory agencies can approve the therapy, and insurance companies can decide to fund the therapy or not.

    From the FDA's point of view, clinical trials provide the evidence necessary for labeling of the therapy, to determine its indication, and to formulate restrictions of the treatment based on safety and efficacy data. In order to succeed, clinical trials must minimize variability so that the results are statistically significant with as few patients as possible.

    Having had an experimental therapy 12 months ago may interfere with the outcome of a trial, particularly since treatment-induced recovery may occur after more than 12 months. That is why most clinical trials will not allow patients who has participated in other clinical trials, not just a year or two ago. To be on the safe side, they would just exclude all such patients.

    The reason why I have been advocating for a one-year grace period in ChinaSCINet is because I don't think that there are any therapies right now that are causing delayed neurological improvements in patients. I know that Carlos Lima is claiming this to be the case in his nasal mucosa transplants coupled with longer term exercise therapies but I think that the recovery is more likely to be due to the multi-year intensive exercise than the nasal mucosal therapy.

    If there are therapies that produce delayed functional recovery, we are likely to change the one year criteria. Consider the situation of a person who had an experimental treatment 12 months, joined a placebo-controlled clinical trial, was randomized to the placebo group, and then recovered function? That would confound the clinical trial.

    Wise.
    Last edited by Wise Young; 10-30-2009, 11:36 PM. Reason: changed the confusing sentence concerning recovery in the Lima study

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    • #3
      thanks wise
      "That's not smog! It's SMUG!! " - randy marsh, southpark

      "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


      2010 SCINet Clinical Trial Support Squad Member
      Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

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