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Thread: Clinical Trials

  1. #171

    Hi

    I would suggest you to navigate about this one on internet. There is lots of information available on this.


    CSK

    Home Based Business

  2. #172
    What I would like to know is whether there are any trials for PLS or related disorders. I was first diagnosed with this (PLS) in 1972. At that time it was suggested that 5 years from then I would see treatments. I am a scientist so I was somewhat dubious about that projected time frame. Still, even though I have been fortunate to work all of these years, be married, have a daughter, a grandson and a home, riding about in an electric chair gets old. I guess I am geek enough to become absorbed in life so that at times I forget my disability. None the less, I would like to walk again! So are there any indications that there is treatment for these type of neurologic disorders?

  3. #173
    Quote Originally Posted by BillV View Post
    What I would like to know is whether there are any trials for PLS or related disorders. I was first diagnosed with this (PLS) in 1972. At that time it was suggested that 5 years from then I would see treatments. I am a scientist so I was somewhat dubious about that projected time frame. Still, even though I have been fortunate to work all of these years, be married, have a daughter, a grandson and a home, riding about in an electric chair gets old. I guess I am geek enough to become absorbed in life so that at times I forget my disability. None the less, I would like to walk again! So are there any indications that there is treatment for these type of neurologic disorders?
    Bill, I presume that you are referring to primary lateral sclerosis (PLS). As you know, nobody has a crystal ball to foretell the future and most experienced scientists and clinicians know that getting therapies through clinical trials always take longer than people think or expect. One should not have to be a scientist to be skeptical of any prediction that a therapy that has not even started clinical trial will be approved within five years. Most scientists and clinicians have never ushered a therapy through clinical trial and regulatory approval.

    While nobody can predict when treatment will come, we do know that the following are true:
    1. The earlier we start, the faster we will get the therapies.
    2. The more clinical trials we have, the greater the likeliood that one or more will be successful in demonstrating a therapy that works.
    3. The time required for approval has several well-established steps that take an average of 11-12 years:
      • Preclinical trials take an average of 4 or more years to accumulate sufficient data to justify clinical trials, assuming that funding is available.
      • Clinical trials take on average of 7 or more years to go through phase 1 through phase 3 for regulatory approval, assuming that funding is available.
      • Regulatory approval may take a year or more.


    On the other hand, I am hoping that there will be confirming trials that lithium is beneficial for amyotrophic lateral sclerosis. As I have pointed out elsewhere, a 2008 study showed that lithium prevented mortality and prevented progression of ALS in a double blind randomized trial. If this is confirmed, this therapy is readily available. Lithium has been used for over 100 years to treat manic depression.

    Wise.

  4. #174
    Super Moderator Sue Pendleton's Avatar
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    Quote Originally Posted by uns007 View Post
    How is that possible a man said this and all of you accept no way me not agree with you.
    What man and what kind of education and work does he do that you will believe him? Always ask both the good and the bad questions.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  5. #175
    Dr.Young, are there some way to get a treatment faster to market? more coordination? better planning?
    I see this 12 years average, and i think is too much.
    -Ramps in buildings are necessary, but it would be usefull to have another ones for people (mind/heart).....

    -Hoc non pereo habebo fortior me

  6. #176
    Quote Originally Posted by Isildur View Post
    Dr.Young, are there some way to get a treatment faster to market? more coordination? better planning?
    I see this 12 years average, and i think is too much.
    Isildur, I think that clinical trial networks reduce the time. Much of the time is wasted organizing trials. One of the reasons why it is so hard right now is just the time required to get the trials going, to recruit the clinicians and to train the clinicians and staff to do the trials. Very few centers in the United States are doing any kind of clinical trial and they are just not set up for the trials. It is not easy to do and one has to have people and facilities.

    For spinal cord injury clinical trials, there is another factor that slows things down. One not only needs a surgeon to do the therapy (if the therapy requires surgery) but one has to have the rehabilitation facility and doctors, physical therapists, and other staff to implement the rehabilitation protocols that I think are essential for successful regenerative therapies. Of course, fundraising is a big issue and it is nice to have funds on hand and ready to go.

    So, if all this can be set up in advance, the trial go much faster. A network can constantly recruit patients and hold them in ready for the trials so that less time is spent recruiting. The trials centers are set and ready to go so that when the therapy becomes available for trial, the trigger can be pulled. All this is of course common sense.

    Wise.

  7. #177
    Super Moderator Sue Pendleton's Avatar
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    So, if all this can be set up in advance, the trial go much faster. A network can constantly recruit patients and hold them in ready for the trials so that less time is spent recruiting. The trials centers are set and ready to go so that when the therapy becomes available for trial, the trigger can be pulled. All this is of course common sense.
    Wise.
    I know of 6 centers that had the capabilities back in 1997/1998. IIRC they were all model systems so they get an extra $1 million a year from the NIDRR. And I am fairly certain they had very decent neurosurgery departments either partnered with them onsite or within a few miles.

    Recruiting would not be a problem. Riot control would be a problem. And that is also, of course, common sense.
    Last edited by Sue Pendleton; 03-04-2009 at 02:17 AM. Reason: spelling
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  8. #178
    Quote Originally Posted by Wise Young View Post
    Isildur, I think that clinical trial networks reduce the time. Much of the time is wasted organizing trials. One of the reasons why it is so hard right now is just the time required to get the trials going, to recruit the clinicians and to train the clinicians and staff to do the trials. Very few centers in the United States are doing any kind of clinical trial and they are just not set up for the trials. It is not easy to do and one has to have people and facilities.

    For spinal cord injury clinical trials, there is another factor that slows things down. One not only needs a surgeon to do the therapy (if the therapy requires surgery) but one has to have the rehabilitation facility and doctors, physical therapists, and other staff to implement the rehabilitation protocols that I think are essential for successful regenerative therapies. Of course, fundraising is a big issue and it is nice to have funds on hand and ready to go.

    So, if all this can be set up in advance, the trial go much faster. A network can constantly recruit patients and hold them in ready for the trials so that less time is spent recruiting. The trials centers are set and ready to go so that when the therapy becomes available for trial, the trigger can be pulled. All this is of course common sense.

    Wise.
    Thanks Wise.
    Do you know how many countries have a sci network established or in progress? only China?
    -Ramps in buildings are necessary, but it would be usefull to have another ones for people (mind/heart).....

    -Hoc non pereo habebo fortior me

  9. #179
    Quote Originally Posted by Isildur View Post
    Thanks Wise.
    Do you know how many countries have a sci network established or in progress? only China?
    There is one in the USA (NACTN sponsored by the Christopher and Dana Reeve Foundation) and one in Europe (I forget the acronym).

    Wise.

  10. #180
    Senior Member KIM's Avatar
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    And... What do we need to start one or promote one over here?

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