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    Speeding up the clinical trials process

    This may have already been asked- I'm not sure. But if not, I'm sure it's on a lot of our minds. Seeing the speed at which things happened with covid-19 in this country what are researchers going to do to speed up the clinical trials process for sci? It's clear (as many of us have felt all along) that the current process is far too time consuming. So I'm wondering are Drs and other researchers in the sci community going to do anything to change this. Is there any organized effort to make this happen?

    #2
    It took me years to actually understand the process, the reality is that very few researchers actually take anything to the clinics.

    Normally what happens is researchers do research, then if something looks good either the researcher starts a company, or a biotech picks it up.
    The researchers don't have all the data needed for regulators, so then that process starts.
    When they have all the data needed to submit for a trial, they do.

    The challenge is that at every one of these steps there is a lot of risk, so its hard to attract the money to do it.

    Contrast that with Covid, there was money being thrown at it from every angle, and then for the Pharma companies the business opportunity was good as well (excluding AZ obviously).

    To me the answer is nearly always money, and the ability to ignore the risk.

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      #3
      Getting funding for this research (which is VERY expensive) is a major barrier. A good example is Dr. Young's study with combination stem cell implants and 6-6-6 ambulation. Original funding source pulled out in 2020, and he has been seeking funding ever since. SCI is not high on the list of priorities for major funding sources such as NIH, and organizations like the Reeve Foundation or the PVA only have limited resources compared to the $$$$ needed.

      (KLD)
      The SCI-Nurses are advanced practice nurses specializing in SCI/D care. They are available to answer questions, provide education, and make suggestions which you should always discuss with your physician/primary health care provider before implementing. Medical diagnosis is not provided, nor do the SCI-Nurses provide nursing or medical care through their responses on the CareCure forums.

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        #4
        I understand what is being stated about money. But I'm not talking about money. From what I understand, it usually takes 7 years or more for drugs, etc. to get through the process. It took less than a year with the covid-19 vaccine. Some of the barriers, if not eliminated, must have been relaxed. Which, to me, means much of this process can be streamlined. Why isn't the current process being questioned? Maybe with a speedier process a cure would have been here by now. Things take far too long in this country, and the time-line has nothing to do with money, but with changing the process, at least as far as I see it. And this isn't even a political matter to get hung up on. I don't think politicians came up with process, rather more than likely it was a group doctors and scientists. So they can change it. Then maybe progress can be made more quickly. But researchers have got to demand change rather than just excepting the status quo.

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          #5
          The research on mRNA as a method for making vaccines has been in the research phase for many years, not just since the onset of the COVID-19 pandemic. The researchers working on it quickly identified it as a methodology that could work for COVID. Keep in mind also that the 3 vaccines approved in the USA were all given emergency use permits by the FDA...they are still going through the laborious steps required for it to be approved by the FDA for formal approval. In addition, the drug developers for the vaccines were given immunity from prosecution and suits for any ill-effects of the vaccines, which can be a huge stimulus for fast-tracking any drug. None of this is available for any SCI-cure studies at this time.

          (KLD)
          The SCI-Nurses are advanced practice nurses specializing in SCI/D care. They are available to answer questions, provide education, and make suggestions which you should always discuss with your physician/primary health care provider before implementing. Medical diagnosis is not provided, nor do the SCI-Nurses provide nursing or medical care through their responses on the CareCure forums.

          Comment


            #6
            It seems to me that we're constantly getting in our own way with more and more reasons why things can't be done instead of making things happen. There are continuous excuses while things drag on and on and on.... I for one have been quite willing to be an experimental subject, but even with that there are roadblocks. We can make happen whatever we want to make happen. It's been done too many times before - we just have to really want to. I've been dealing with the agony of sci for almost 42 years, and I know some have been living with it far longer. I believe many of us would forgo lawsuits (I mean, we wouldn't even consider suing) for a real shot at walking and the return of other function that seems to be a by-product of such motion, if it would happen in our lifetime. We really need change. I've heard it said, "if you keep on doing the same thing, you'll get the same result". That seems to be true in this case. You in control (or who are influencers), please, please, please change the process!

            Comment


              #7
              I agree with you 100%.

              I don't think research is going to change though. Anyone remember this:
              https://www.ninds.nih.gov/News-Event...al-Cord-Injury

              Maybe someone should email lyn.jakeman@nih.gov and see what has been disrupted.

              I know that's US specific, but I don't see anything changing in the UK either.

              Comment


                #8
                Maybe we can get Bezos to postpone his desire to sell birthday parties in space to rich kids for $28 million. Probably not .. . . . everyone has their priorities and we are not it๐Ÿ˜ž.
                please . . .test what you already know; and give us what you have. we may not be dying, but we certainly are not living either

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                  #9
                  Originally posted by Nicksdad View Post
                  Maybe we can get Bezos to postpone his desire to sell birthday parties in space to rich kids for $28 million. Probably not .. . . . everyone has their priorities and we are not it๐Ÿ˜ž.
                  I know that was in jest, but the fact the majority of the SCI community does nothing in terms of raising money for research, or even caring about it, shows the rest of the world that it's not important.

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