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Thread: Clinical Trials

  1. #521

    Trial Plasticity

    As we are heading toward more human trials, I think real chance for success
    will have TRIAL organized with the most PLASTICITY.
    To make it possible, trial team must have ability to include obvious and proven findings that would improve outcome of the whole project toward the final goal of SCI healing.
    If trial is organized to allow dynamic changes in certain aspects, it would be easier and faster to change the course slightly within a trial rather than start everything from the beginning.
    I think Dr. Wise's trial has all potentials and as Dr. Wise has already mention, will consider to include the newest findings in the field that would improve chances toward final SCI healing procedure success.

    Hypothetically speaking if trial has a way to include some Ch'ase delivery by genetically modified cells, Dr. Silver's team findings, Dr. Davies findings, Dr. Reynolds scaffold findings or Italian team finding of self assembling pep-tides - or any new procedure finding and - as well - other doctor's, researchers or teams, there should be more chances for success and for me to walk out from this great Forum!

    The most of us got no clue what doctor's and researchers are dealing with
    and would it be possible at all to include published research / findings just like that...

    How to overcome administrative and financial hurdles?
    How to overcome Investor interest conflicts?
    How to establish communication and overcome people's vanity?

    I think that finding MECHANISM to improve Trial PLASTICITY
    could actually accelerate everything....
    www.MiracleofWalk.com

    Miracles are not contrary to nature, but only contrary
    to what we know about nature
    Saint Augustine

  2. #522
    Senior Member
    Join Date
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    Comad good post and questions

  3. #523
    cirm.cal responded to me today. I responed to their announcemet yesterday that they got funding and were working towards a cure for spinal cord. I responded and said your announcement is nothing more but words and nothing is getting done by you for us. The reponse I got was that they are aware of my concerns. They are years away from any real therapy or cure. Given this , I see them as no better than the Miami Projectl or Hanson foundation. This, again, leads me to Wise Young and his therapies that are being tested on humans in China. Now, what we need, is a clear consise answer form wise if he is on schedule on the next year to year and a half to be in a postion to treat us. His presentation at Rutgers was good but vague. Wise, what is the realistic date or time frame for treatment s to start for us.

    anthony

  4. #524
    Quote Originally Posted by comad View Post
    As we are heading toward more human trials, I think real chance for success
    will have TRIAL organized with the most PLASTICITY.
    To make it possible, trial team must have ability to include obvious and proven findings that would improve outcome of the whole project toward the final goal of SCI healing.
    If trial is organized to allow dynamic changes in certain aspects, it would be easier and faster to change the course slightly within a trial rather than start everything from the beginning.
    I think Dr. Wise's trial has all potentials and as Dr. Wise has already mention, will consider to include the newest findings in the field that would improve chances toward final SCI healing procedure success.

    Hypothetically speaking if trial has a way to include some Ch'ase delivery by genetically modified cells, Dr. Silver's team findings, Dr. Davies findings, Dr. Reynolds scaffold findings or Italian team finding of self assembling pep-tides - or any new procedure finding and - as well - other doctor's, researchers or teams, there should be more chances for success and for me to walk out from this great Forum!

    The most of us got no clue what doctor's and researchers are dealing with
    and would it be possible at all to include published research / findings just like that...

    How to overcome administrative and financial hurdles?
    How to overcome Investor interest conflicts?
    How to establish communication and overcome people's vanity?

    I think that finding MECHANISM to improve Trial PLASTICITY
    could actually accelerate everything....
    A dynamic protocol as you are describing is an anti-pattern of what clinical trials are. Trials need to have a rigid protocol from the outset. Otherwise, this would be considered human experimentation

    However, I agree that testing combinatory approaches needs some 'out of the box' thinking as the current set-up is one-paced and inefficient.

  5. #525
    Did I see the Va hospital, don't know which one, as a candidate for wise's trial in the US? this would be huge as just the cost savings for the military would be huge.

  6. #526
    Comad,

    Very good questions. I am sorry that I did not have time earlier to answer this. Let me give a general answer first and then more specific answers.

    Spinal cord injury networks are the most efficient way to do clinical trials for the following reasons:

    1. Setting up. Over 80% of the work in getting a clinical trial started are meetings, committees, institutional review boards, approvals, contracts, and other paperwork needed to get each center organized, trained, and ready to do clinical trials. Personnel must be recruited in each center to do the work. Patients must be recruited and informed. All this typically takes a year or more. If this has to be done every time that one does a clinical trial, one should expect a year or more delay for each trial.

    2. Running the trials. Experience is essential. In the past decade, several multicenter clinical trials had been carried out in the U.S. (i.e. Pro-Neuron, Cethrin, Fampridine, and Geron). Because of these trials, many centers are able to do clinical trials much faster and better than before. When a center is in an active network, each trial that the network does makes the participating centers better and more efficient.

    3. Planning. Networks can plan trials in advance. It frequently takes a year or more to get trial protocols approved and submitted to the FDA. By doing this while another trial is going is of course much more efficient. That is the practice that I am pushing for ChinaSCINet, SCINetUSA, etc. to do. We are thinking 2-3 years ahead and making sure that the resources are available, talking to the scientists and companies to ensure that the therapies are ready to go, and to make sure that the data is available to support the decision to go to trial with a particular therapy.

    Dynamic changes while a clinical trial is running is a very powerful idea that groups of statisticians and clinical investigators have been working on. Rather than waiting for the full data of a trial to become available, computers are programmed to analyze the data and offer recommendations for the directions to go in the trials while the trial is going on. This approach towards clinical trial design is called Bayesian. For example, here is an article arguing for Bayesian trial designs for stroke http://stroke.ahajournals.org/content/36/7/1623.full.

    You are talking about an even more difficult concept, i.e. incorporating new knowledge (from outside of the trial) into the trial design while the trial is going on. Although this is possible, the problem is how one can do thiswithout corrupting the trial design and making it less credible. First, one can anticipate certain findings from animal studies or other clinical trial. If one has certain findings, then one would propose to change an ongoing trial in the following way. Second, methods must be developed to assess the impact of such changes on the statistical analyses of the results. Third, the changes must be assessed very carefully to rule out bias of the results due to the changes of trial design.

    We are not yet ready to change clinical trial design that radically yet but I believe the these changes are coming.

    Wise.




    Quote Originally Posted by comad View Post
    As we are heading toward more human trials, I think real chance for success
    will have TRIAL organized with the most PLASTICITY.
    To make it possible, trial team must have ability to include obvious and proven findings that would improve outcome of the whole project toward the final goal of SCI healing.
    If trial is organized to allow dynamic changes in certain aspects, it would be easier and faster to change the course slightly within a trial rather than start everything from the beginning.
    I think Dr. Wise's trial has all potentials and as Dr. Wise has already mention, will consider to include the newest findings in the field that would improve chances toward final SCI healing procedure success.

    Hypothetically speaking if trial has a way to include some Ch'ase delivery by genetically modified cells, Dr. Silver's team findings, Dr. Davies findings, Dr. Reynolds scaffold findings or Italian team finding of self assembling pep-tides - or any new procedure finding and - as well - other doctor's, researchers or teams, there should be more chances for success and for me to walk out from this great Forum!

    The most of us got no clue what doctor's and researchers are dealing with
    and would it be possible at all to include published research / findings just like that...

    How to overcome administrative and financial hurdles?
    How to overcome Investor interest conflicts?
    How to establish communication and overcome people's vanity?

    I think that finding MECHANISM to improve Trial PLASTICITY
    could actually accelerate everything....

  7. #527
    Wise i got a good question for you. How wmuch would be needed to do both clinacal trails next year side by side like you explained with the UNBLC Stem cells and nerons Cethrin? also i got another question is the Cethrin ready aviliable to do clincal trails or do we have to wait on that? also i was wondering if it could set out how much it would cost to do a trail for each person so that ppl can help raise money for the trail that they are goin to be in i think that will help motivate ppl. Also can the trail start before mid 2013 if the money is aviliable?

    Quote Originally Posted by Wise Young View Post
    Comad,

    Very good questions. I am sorry that I did not have time earlier to answer this. Let me give a general answer first and then more specific answers.

    Spinal cord injury networks are the most efficient way to do clinical trials for the following reasons:

    1. Setting up. Over 80% of the work in getting a clinical trial started are meetings, committees, institutional review boards, approvals, contracts, and other paperwork needed to get each center organized, trained, and ready to do clinical trials. Personnel must be recruited in each center to do the work. Patients must be recruited and informed. All this typically takes a year or more. If this has to be done every time that one does a clinical trial, one should expect a year or more delay for each trial.

    2. Running the trials. Experience is essential. In the past decade, several multicenter clinical trials had been carried out in the U.S. (i.e. Pro-Neuron, Cethrin, Fampridine, and Geron). Because of these trials, many centers are able to do clinical trials much faster and better than before. When a center is in an active network, each trial that the network does makes the participating centers better and more efficient.

    3. Planning. Networks can plan trials in advance. It frequently takes a year or more to get trial protocols approved and submitted to the FDA. By doing this while another trial is going is of course much more efficient. That is the practice that I am pushing for ChinaSCINet, SCINetUSA, etc. to do. We are thinking 2-3 years ahead and making sure that the resources are available, talking to the scientists and companies to ensure that the therapies are ready to go, and to make sure that the data is available to support the decision to go to trial with a particular therapy.

    Dynamic changes while a clinical trial is running is a very powerful idea that groups of statisticians and clinical investigators have been working on. Rather than waiting for the full data of a trial to become available, computers are programmed to analyze the data and offer recommendations for the directions to go in the trials while the trial is going on. This approach towards clinical trial design is called Bayesian. For example, here is an article arguing for Bayesian trial designs for stroke http://stroke.ahajournals.org/content/36/7/1623.full.

    You are talking about an even more difficult concept, i.e. incorporating new knowledge (from outside of the trial) into the trial design while the trial is going on. Although this is possible, the problem is how one can do thiswithout corrupting the trial design and making it less credible. First, one can anticipate certain findings from animal studies or other clinical trial. If one has certain findings, then one would propose to change an ongoing trial in the following way. Second, methods must be developed to assess the impact of such changes on the statistical analyses of the results. Third, the changes must be assessed very carefully to rule out bias of the results due to the changes of trial design.

    We are not yet ready to change clinical trial design that radically yet but I believe the these changes are coming.

    Wise.

  8. #528
    Quote Originally Posted by moneymaker View Post
    Wise i got a good question for you. How wmuch would be needed to do both clinacal trails next year side by side like you explained with the UNBLC Stem cells and nerons Cethrin? also i got another question is the Cethrin ready aviliable to do clincal trails or do we have to wait on that? also i was wondering if it could set out how much it would cost to do a trail for each person so that ppl can help raise money for the trail that they are goin to be in i think that will help motivate ppl. Also can the trail start before mid 2013 if the money is aviliable?
    At the present, we are not planning to do Cethrin until 2014. The reason is because Cethrin still needs to be manufactured for the trial and we are committed to doing the UCBMC±lithium phase III trial in 2013. We must get the data for our current phase II UCBMC±lithium trials to apply for the phase III trials. It takes time to get IND's approved. Mid-2013 start is our goal.

    It is true that if we have the money, we might be able to do parallel trials but that would require substantial organization and more centers than we currently have. I am already writing grants to try to fund phase II trials combining UCBMC, Cethrin, and lithium that can be carried out concurrently with the phase III trial.

    It is not appropriate for each person to raise money for participating in the trial. That would be similar to the person paying to get in trial. There should be no linkage between a person raising money and getting into the trail. If people raise or give money to a clinical trial fund, it should have no influence on whether the person participates in the trial or not.

    Wise.

  9. #529
    Wise--Would it be appropriate for a person selected for a clinical trial to pre-fund their travel and lodging expenses if they were not living in the same city as the trials center?

  10. #530
    Quote Originally Posted by 6 Shooter View Post
    Wise--Would it be appropriate for a person selected for a clinical trial to pre-fund their travel and lodging expenses if they were not living in the same city as the trials center?
    6 Shooter, yes, of course, a person can fund travel and lodging expenses if they travel to a clinical trial site. There is no law or requirement that a clinical trial center has to pay for travel, unless it is seeking subjects who must travel. Perhaps I should explain what the regulations are. GCP (good clinical practice) standards require that subjects not pay for experimental therapies.

    If hospitalization and medical care would being delivered anyway to a patient for their medical condition and would be covered by insurance, medicare, or sources other than the patient, the clinical trial sponsor does not have to pay. That is one of the reasons why so many companies want to treat acute or subacute spinal cord injury. This way, they don't have to pay for the hospitalization or care. Their therapy is just added to the others.

    If the care, treatment, rehabilitation, or other care delivered during the trial has accepted benefits, the FDA often will allow the trial to charge for such services. For example, I suppose that one can claim that locomotor training is beneficial and some insurance companies will cover that kind of training. If so, it is possible to state this on an IND and get it approved.

    We are reluctant to do this for the following reasons. Let me give an example. If we have to charge for the locomotor training, it would rule out people who can't afford this amount to participate in the trial. It would also mean that we would not be able to randomize the locomotor training.

    The initial new drug/device (IND) application must be approved by the FDA and the trial protocol must be approved by the institutional review board (IRB) of the hospital that is carrying out the trial. The FDA and the IRB are unlikely to and should not approve of any trial where the subjects are paying for experimental therapies.

    Wise.

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