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Thread: Millions of Americans Living With Paralysis Provided Hope with the Introduction of the Christopher Reeve Paralysis Act of 2003

  1. #11
    Senior Member Schmeky's Avatar
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    Wise,

    Assuming passage of the bill and funding is secured, how long do you estimate establishment of a clinical trial infrastructure and subsequent initiation of human trials? 2, 3, 4, 5 years?

  2. #12
    Schmeky, I have been urging NICHD for the past two years to initiate such a clinical trial network. Although the administrators were sympathetic, they had so many other priorities that the SCI Clinical Trial Network kept slipping off the agenda. Congress actually passed legislation suggesting a Traumatic Brain Injury Clinical Trial Network about two years ago and they got that going in less than two years.

    I think that NICHD is planning the clinical trial network as soon as funding becomes available. Much depends on the response of the clinical community but I expect that many centers will want to be part of this network. If NICHD puts together a program, it has to go through all sorts of internal review and approval. This may take 6 months. You have to give people at least 6 months to write and submit the application. The review may take 3 months. Therefore, the earliest that the network would start would be a year from now. The network then has to work together, discuss the therapies that they want to test, and implement. This may take a year. So, two years is probably a reasonable time.

    Wise.

  3. #13
    Banned Acid's Avatar
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    Comment

    "The Foundation also vigorously works to improve
    the quality of life for people living with disabilities"
    And "vigorously works" to finance disabilities and reduction of health to be pervertly inflicted into imprisoned women and men, who are so related in their brains to those of our kind, that one can straight deduct to those of our ape mammal kind due to our kinds' high brain similarity.

    One might assume that parts of such money would be used to further disgrace our history with more of such atrocious crimes.

  4. #14
    Wise, probably a stupid question but are you being consulted (along with many others in the field of paralysis study) as to how, where, when these monies are spent?

    What do you think is the first/primary priority?

    More importantly, what do you think the holder's of the purse strings (i.e. gov't) believe is their first priority?

  5. #15
    Phebus,

    By virtual of having been in the field for a long time, I haveparticipated in most of the major developments of spinal cord injury research. In 1997, when I moved from NYU to Rutgers, I believed that we needed two things for the field.

    1. more and better scientists doing spinal cord injury research
    2 a clinical trial network to facilitate movement of therapies into trials.

    In the mid-1990's, I worked very hard with Arthur Ullian to double the NIH budget in the mid-1990's. In order for the field to take advantage of the budget increase, however, we needed more and better scientists to apply to NIH for grants. In 1996, we reached the nadir of spinal cord injury research. There were only about 100 NIH grants supporting spinal cord injury in that year. When I moved to Rutgers in 1997, my highest priority was to train as many scientists as possible to carry out more spinal cord injury studies.

    Over the past five years, at Rutgers, we have been holding 4 spinal cord injury workshops per year, training as many as 50 scientists a year to do spinal cord injury research. I don't know whether our efforts have had anything to do with it, the number of NIH grants for spinal cord injury has been increasing steadily during the period (see graph below). NIH is currently funding over 400 grants that is related to spinal cord injury research.

    The next step is to get more spinal cord injury clinical trials going. I pushed for this on two levels. The first was to convince the industry that spinal cord injury is worth investing into. In 1995, there were no companies that had spinal cord injury as its primary mission and certainly no company that had money to invest in spinal cord injury clinical trials. The large pharmaceutical companies thought that spinal cord injury was a small and risky market. So, the only solution was to form a company that had spinal cord injury as its primary mission. I worked closely with Ron Cohen to form such a company (Acorda), in the hopes that it could lead the way for the rest of the companies. The second was to convince NIH to fund more clinical trials and a clinical trial network. Hopefully, this will happen soon. In the meantime, overseas clinical trials are going on. Our goal should be to make these trials as good as they possibly could be and encourage them to publish in U.S. journals.

    The following graph gives the number of NIH grants supporting spinal cord injury research. Note that it was at about 100 grants in 1996. The number has risen steadily to over 400 grants in 2002. The numbers for 2003 are not accurate because the year is not yet over but I anticipate that it may be over 500 grants. Incidentally, by comparison, I included data concerning spinal cord injury grants involving stem cell (SC) transplants, embryonic stem cells (ESC), and olfactory ensheathing glia.

    Wise.
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  6. #16
    Senior Member DA's Avatar
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    The next step is to get more spinal cord injury clinical trials going.



    dr young hopefully not just any trials. understand?

  7. #17
    Senior Member chastev8's Avatar
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    Julie Bowen from the TV show "Ed" was just on Jeopardy, playing for CR and SCI. She did not bet enough to win because she did not bet enough in final jeopardy. She did manage to get 27,500 though!

  8. #18
    Senior Member DA's Avatar
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    nobody in sci seem to take big chances. in vegas they would kick out sci researchers for betting 1 cent on the penny machines.

  9. #19
    Senior Member DA's Avatar
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    . You have to give people at least 6 months to write and submit the application. The review may take 3 months. Therefore, the earliest that the network would start would be a year from now. The network then has to work together, discuss the therapies that they want to test, and implement.



    6 months to write. is it 10,000 pages or they write 1 sentence per week.

    6 month to review. this can be done in a week. how do it takes 6 months to review, read it 10,000 times or read 1 sentence per week.


    discuss therapy they want to test. i can count on my hands the number of therapies for sci regeneration. its not like we have 10,000 to discuss but a whole year is needed. they must discuss 1 therapy per month.

  10. #20
    DA, NIH grants are typically about 25 pages (single space) and it does take even an experienced investigator months to write. This is because you have to include data and other information that would convince the reviewers to award up to a million or so dollars to you to do research. You have to specify that you are going to do, why, and demonstrate both feasibility and importance of the proposed research. The grant usually must include data supporting the study.

    The paperwork from the university side is also onerous. Besides 3 forms that an investigator needs to write and get signed by at least three people (department chair, division administrator, and grants administration office), you have to fill out forms for animal use, hazardous chemicals, health forms, and certificates for everything you can imagine. The animal forms represent another 25 pages or so of detailed descriptions and justifications of every thing that will be done to the animals.

    If the project involves human subjects, you can count on even more delays. You have to write an application to the university. This often takes a month or more to clear (since the committees meet monthly); it may take longer if there are any problems with the applications. To transplant some human blood into animals, I have to fill out IRB (institutional review board) forms, as well as animal forms.

    Sometime ago, I was warning everybody here about how the Jesse Gelsinger case will increase the paperwork and regulation of clinical trials at Universities. It is happening. The paperwork for clinical trials has now doubled. I understand that the revised regulations and oversight of IRB has increased to such an extent that the 4-AP trial was delayed for over 3 months at many institutions. This is just a trial with a well-defined drug that has been extensively studied and shown to be safe. Finally, to do a clinical trial, you now must fill out FDA and NIH forms as well. NIH will not review the grants until you have actually put the applications in.

    The NIH must post a notice of the grant for a period and give investigators adequate time to write and submit applications, including all the paperwork that is necessary to fulfil the maze of regulations. Thus, 6 months from announcement to submission date would be fast, assuming no hitches in the process.

    Wise.

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