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Thread: The E-Stand clinical trial is suppose to start today ...

  1. #21
    Getting 100 people through all has to do with funding.

  2. #22
    Quote Originally Posted by Skipow View Post
    Getting 100 people through all has to do with funding.
    And it doesn't magically just appear no matter how promising a therapy looks. Funding grants and venture capital takes a lot of time and work to acquire not to even mention the regulatory hurdles.

  3. #23
    Quote Originally Posted by niallel View Post
    My point has ZERO to do with safety, it has to do with speed and so was the initial point from Silvio. Please stop making out that we don't care about safety.

    They are doing 20 people a year. If they did 100 people in a year they would still have the same amount of information and it would be done in 2 years.
    The initial point from Silvio was that researchers "don't care" about getting this treatment to people.

    I never meant to say that you or anyone else personally don't care about safety. I suggest you study the logistics of what it takes to run a trial like this. 20 people a year seems ambitious to me, honestly, but the Mayo clinic wouldn't be shooting for that if they didn't think they could do it. I'd bet money that 100 people in 2 years would be impossible for any facility, and I'm not even considering funding - simply having the physical resources to perform the surgery, and provide long-term and follow-up care as well as physical rehabilitation for 100 clinical trial subjects in 2 years is what would make it impossible.

  4. #24
    Quote Originally Posted by Silvio GS View Post
    Yes you're right, every detail should be worked out especially safety wise before bringing it to the market, even though it's already believed to be safe enough. But still, 6 years seems like a bit too long, it's not like they're starting from scratch on some novelty kind of device, it's more like refining a product that's been worked on for years now. If funding wasn't a problem, and if they'd really aim to make it available ASAP, I imagine that even the 100 patients trial would be finished a lot quicker. In my opinion for some researchers there's no need to push things faster, because at the end of the day it's just a job for them, which is possible well paid, and why rushing...
    And by the way, there are other similar studies going on right now that I trust them to be out a lot sooner.
    And also I think that a lot of patients would rather "take the risk" and try it out before it's completely tested, instead of waiting for years and years. Some, if given the opportunity would happily even pay their way into the trials, me included
    Believed to be "safe enough" based on what? We have published results on four males with SCI. That's hardly representative of the SCI population.

    This research is fine-tuning an idea that was first tested in 2010-ish. The device itself has been used for neuropathic pain for decades - but that is totally different then trying to improve motor function after SCI.

    You say "if funding wasn't a problem" - so you admit that some things, like the funding available, is not in control of the researchers.

    "...for some researchers there's no need to push things faster, because at the end of the day it's just a job for them..." Which researchers? What researchers have you met and talked to who say that it's just a job for them? Please, name names. Did you ever consider that some researchers are passionate about what they do, but they are subject to legal regulations, academic regulations, or academic calendars and other obligations that slow down the progress of their research?

    You're right that a lot of people would like to take a risk and get a device before it's proven safe or effective, and I have heard many people say they would pay their own way into a trial if they could. But there are ethical and legal ramifications to both of those things. There are reasons that there are laws against people paying their own way in to trials. Blame lawmakers for your inability to do that, not the people doing the researchers.

  5. #25
    Yes, for some researchers it's just a job, in a line of work that they chose to practice. On the other hand, there are other researchers that are passionate and possibly with a personal motivation. And I probably sounded like I'm really annoyed with the researchers, which would be stupidly inappropriate. I am actually greatly thankful to anyone involved in SCI research. But when I see time frames like in this trial, it makes me think that there's more that they could do. Nevertheless, the laws and regulations are the main reason of the slow progress.
    Anyway these are just some thoughts out of frustration... it's even pointless to argue about

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