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Thread: procedures in clinical trial

  1. #1
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    procedures in clinical trial

    I have a serious question. If a procedure, such as Dr. Huang's goes into clinical trial tommorow, how long would it be before people will be able to have that surgery? if it is a success.

  2. #2
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    I heard average is 12 years?
    5-6 years for animal testing
    5-6 years for clinical trials
    So if your okayed for clinical trils for FDA approval 5-6 years.

  3. #3
    Senior Member Schmeky's Avatar
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    If an SCI cure was discovered TODAY, clinical trials would take a minimum of 5 years BEST case scenario before we could treated.

    Average would be 7, worst case could be 12. This is following FDA protocol in the USA.

  4. #4
    That's in the US, we all know we'll be going to China for the cure while the FDA drags it's ass.

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  5. #5
    Given the US government's lack of attention to any SCI cure we will probably be going to a foreign country. My guess is 2-4 years.

    Deb

  6. #6
    Senior Member Schmeky's Avatar
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    Jimnms,

    I agree.

    Debbie,

    Sure hope so. First off, a chronic treatment must be discovered, which hasn't happen yet.

  7. #7
    i don't know Brian - there are clinical trials happening in Brisbane but the progress is confidential.

  8. #8
    BrianJ,

    I assume that your question refers to FDA approval of the therapy. It may take longer for doctors to adopt a therapy, even after it is approved by the FDA, since FDA approval does not guarantee that clinicians will believe the results or are prepared to practice the therapy.

    A lot depends on the therapy.

    1. Efficacy. If a treatment is impressively effective and phase 3 trial data (pivotal) were able to show efficacy and the trials were registered with the FDA (i.e. the trial design is pre-approved by the FDA), it may conceivably occur in 2 years. The FDA normally requires two phase 3 "pivotal" trials, meeting pre-agreed upon criteria of efficacy. Incidentally, clinical trials that are carried out overseas may be registered with the FDA. The trials of course will have to meet FDA standards.

    2. Availability. A treatment may not be available in the United States. For example, embryonic stem cells and fetal cells are simply not available in sufficient quantity in the United States.

    3. Funding. This is often the major bottleneck. Because clinical trials are expensive, many companies require substantial phase 2 data before they are willing to commit hundreds of millions into a phase 3 trial. Many of the therapies for spinal cord injury are not "products" that would make money for a company (for example, OEG cells would not fit with most pharmaceutical company business models). Therefore, just convincing a company to invest may take a long while. NIH funding will take even longer to get because there is a built-in one-year delay in applying for funds and peer review is very critical. The fastest and most efficient way of moving therapies rapidly from laboratory to clinical practice to is to make sure that there are continuing phase 2 and phase 3 trials going on in a well-established spinal cord injury clinical trial network.

    Wise.

  9. #9
    Originally posted by Wise Young:

    3. Funding. This is often the major bottleneck. Because clinical trials are expensive, many companies require substantial phase 2 data before they are willing to commit hundreds of millions into a phase 3 trial. Many of the therapies for spinal cord injury are not "products" that would make money for a company (for example, OEG cells would not fit with most pharmaceutical company business models). Therefore, just convincing a company to invest may take a long while. NIH funding will take even longer to get because there is a built-in one-year delay in applying for funds and peer review is very critical. The fastest and most efficient way of moving therapies rapidly from laboratory to clinical practice to is to make sure that there are continuing phase 2 and phase 3 trials going on in a well-established spinal cord injury clinical trial network.
    So what you're saying is that nobody wants to cure SCI unless they'll make a profit from it?

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  10. #10
    Senior Member Belle's Avatar
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    Wouldn't an SCI therapy that didn't include some saleable product pretty much have to stay in the public domain and be funded by public sources? If there isn't anything to sell per se, why would a company get interested? I think this just means that massive funding sources in the provate sector would not be involved, just public funds.

    Is that what you meant, Wise?

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