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Thread: Research Leaders Discuss Issues in Moving Research to Human Trials

  1. #1
    Senior Member chastev8's Avatar
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    Research Leaders Discuss Issues in Moving Research to Human Trials

    On February 3rd and 4th, 2003, Miami Project Scientific Director W. Dalton Dietrich, Ph.D., joined leaders of other major North American spinal cord injury (SCI) research groups in Bethesda, Maryland at a workshop entitled "Translating Promising Strategies for Spinal Cord Injury Therapy." The National Institute of Neurological Disorders and Stroke (NINDS) has initiated new funding programs to actively accelerate translational research. Thus it is especially timely for SCI research groups to openly discuss and coordinate their efforts to translate promising pre-clinical research to human clinical trials. The workshop, sponsored by NINDS, was designed to promote the exchange of information about the scope and aims of each group's programs and enlist their help in identifying, targeting and accelerating research areas ready for translation.

    Naomi Kleitman, Ph.D., NINDS Program Director and workshop organizer said, "As the lead federal funding agency for SCI research, the NINDS is ideally suited to initiate and lead discussions among major SCI research groups to focus on the translation of basic research to clinical studies." She developed the workshop based on input from individual researchers as well as the International Campaign for Cures of SCI Paralysis, a group of voluntary agencies that fund SCI research in the United States, Canada, the United Kingdom and Australia. The Christopher Reeve Paralysis Foundation (CRPF) also provided support for the workshop.

    In addition to the leaders from various university-based research programs, representatives from the NIH, Food and Drug Administration, Veterans Administration and the CRPF and International Spinal Research Trust participated. "The breadth of representation and the direct interaction between private, public, funding, regulatory, and research agencies was truly exceptional," continued Kleitman.

    Strategies being pursued in multidisciplinary translational research were discussed candidly, as areas of both agreement and controversy emerged. The meeting was considered very valuable for all involved, and a working group involving basic scientists and clinical researchers was developed to provide follow-up on trial development for the larger SCI research community.
    Miami Project Hosts Scientific Conference
    The American Spinal Injury Association will hold its annual meeting in Miami from April 4-6, 2003. As a pre-course to this national conference, an all day scientific conference entitled, "Translational Research and Spinal Cord Injury: Avoiding Potential Pitfalls," will take place at The Miami Project on Thursday, April 3, 2003. Co-directed by Marca Sipski, M.D., Director of the VA Rehabilitation Research and Development Center of Excellence in SCI, and W. Dalton Dietrich, Ph.D., Scientific Director, the course will discuss issues associated with moving research from the laboratory to human trials.


    The conference sessions will discuss neuroprotection, cellular therapies, neural regeneration, scientific methods for measuring functional recovery, and relevant models for pain and spasticity. Participants will also examine issues related to evaluating benefits in animals prior to transferring experimental therapies to humans. A review of the FDA approval requirements to move laboratory studies to human subjects will also be included.


    This conference is designed for clinicians, clinical researchers, basic scientists and industry personnel and is sponsored by the VA Rehab Research and Development Center of Excellence in Functional Recovery and Chronic SCI, The Miami Project to Cure Paralysis, the South Florida Model SCI System and the Journal of Rehabilitation Research and Development. Professional colleagues may obtain further information or register at www.asia-spinalinjury.org/annualmeeting/index.html.

  2. #2
    Well slap me with a stick and call me happy!!!!!

    This sounds strangely like . . . dare I say it???? A Cure Summit.

    The only missing players . . . us.

    Call me crazy but this seems . . . rather . . . strange. . . doesn't it?

    Just wondering.

  3. #3
    Senior Member Leo's Avatar
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    Lars, as I was reading that I was thinking of you. Consperacy.....eh

  4. #4
    Phebus, Jeff, Curtis, Seneca, Vgrafen, Debbie 7, DA, Mckawolski (sp sux again), PN, Joshua, Curtis2, Whiterabbit, bareback, dogger, Mad . . . the list goes on

    Does this bother you guys or is it just me????? The researchers get together, talk about priorities, funding, etc. Everybody is there BUT consumers!!!!

    And then they wonder why they can't get the SCI community to buy in????

    Am I missing something??????

    Should I care???? Is this just some compulsive obsessive disorder that I have?

    What?

  5. #5
    Senior Member DA's Avatar
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    i agree lars. i was thinking the same thing the first time i read it. they make all the choices for our lives and we have no say.

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    Senior Member Jeff's Avatar
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    I agree but at least they're doing something. It's time to get these therapies proceeding. We might not have a say but at least everyone else involved does.

    Of course there were a lot of great research groups that weren't represented there in addition to the general SCI community. But to read that NINDS is working with researchers and clinicians to move toward clinical trials is hard for me to argue with.

    It is good news.

    ~See you at the SCIWire-used-to-be-paralyzed Reunion ~

  7. #7
    Agreed Larwatson, DA. This is why distance learning (video conferencing) could be effective. At least we would have a voice

    The only there will probably be Marc Buoniconti smiling with the celebs.

  8. #8
    Larwatson, I was at this meeting. We scientists also need education concerning what we can do to help accelerate movement of therapies to clinical trials. The FDA was at this meeting and gave some very useful information concerning what would be required. The scientists are trying very hard to initiate such meetings, getting attention on the problem, and meeting with each other.

    I agree that a summit is needed. It is important to form a working group of "consumers" who are knowledgeable about clinical therapies and trials. In order for a summit to work, a lot of work needs to be done. This includes setting up an agenda, defining the issues, finding out who should be present, etc.

    Phebus, there were at least three people in wheelchairs at the meeting, representing the ISRT (International Spinal Research Trust). Marc Buonocanti was not there.

    Wise.

  9. #9
    Senior Member Schmeky's Avatar
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    I am happy to see that some form of clinical collaboration seems to moving in a positive direction. However, we (being the USA) appear to be several years behind other countries. I hope we are not still groping and organizing while others are getting people on their feet.

  10. #10
    Larry, this is almost identical to your proposal but these meetings are held annually and are invitation only. The reason consumers are not invited is because researchers tend to focus their attention on those most likely to fund their research which is the NIH and the heads of the private fundraising organizations, not private donors. That is why they go to Naomi Kleitman and CR instead if visiting CC.


    She developed the workshop based on input from individual researchers as well as the International Campaign for Cures of SCI Paralysis, a group of voluntary agencies that fund SCI research in the United States, Canada, the United Kingdom and Australia. The Christopher Reeve Paralysis Foundation (CRPF) also provided support for the workshop.

    What researchers don't realize is that the closed door policy prevents information from being shared with potential supporters and potentially new areas of revenue. I understand that a researcher cannot be both researcher and fundraiser and that it is the responsibility of others to locate and identify funders but those orgs. have not been as effective as they should to be. If they were, SCI research would not be as underfunded as it is.

    Posted by Larwatson:
    You can't expect to get a ground swell when these folks don't have a clear grasp on what they should be advocating for. Sure it SEEMS like they should have a pretty good idea, BUT guess what? They DON'T. And if they do they think its hopeless because the researchers aren't working together and seem interested in their own little worlds more than in getting a cure on line.

    Wise Young has the respect and admiration of this community because he talks to us. If his name is attached to legislation people would lay down their best efforts to support him. Why, because he talks to them. If the other researchers reached out into the community even a tenth of what Dr. Young does, then we would be getting somewhere. Heck, if we saw them working together in a coherent manner we would be getting somewhere. But right now, for a large part it appears that the researchers want our support to get them the dollars and legislation they want so they can go play in their labs, but by golly don't be talking to them about their research efforts and priorities. Whether this is true or not . . . perception is reality.
    I agree. An effective grassroots campaign cannot be run on rumors, hints and innuendo. The entire SCI community needs to be embraced and given access to the same information the heads of the ICC and the CRPF have. To become active and get more involved we need hope and proof that a cure could be made available in a few years if only we had more money. CR has that hope because he's had access to privileged information, he has seen the unpublished data, trial plans, therapy ideas, timetables etc., whereas we have not. We're still being told by the rank and file that a cure is not possible and we wonder why there's so much apathy in our community. Hopelessness breeds indiffference. How can we motivate ourselves to act we aren't given access to the information that will give us the hope.

    The "Translating Promising Strategies for Spinal Cord Injury Therapy" workshop as well as all the others, should be accessible to the public via an open invititation, video conferencing or transcripts. SCI sufferers and their families cannot be expected to advocate effectively when they are being left out of the process. Dr.Young may believe that a grassroots movement could effect change but I'm not sure if the majority of the researchers believe this. If they're going to go this alone then they need to hire a lobbyist, as DA suggested, to secure the funds they need but something has to change because the current process isn't working very well.

    Dr. Young, I wrote this before I saw your response. I am glad to hear that there were 3 SCI'ed representatives from the ISRT at that meeting, hopefully, they'll get the word out.

    [This message was edited by seneca on 03-01-03 at 19:43.]

    [This message was edited by seneca on 03-01-03 at 22:35.]

    [This message was edited by seneca on 03-02-03 at 04:57.]

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