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    • #19597
      Richard
      Participant

      Hi All,

       

      You have the opportunity to express your opinions on how to fix ALS clinical trials

       

      https://iamals.org/action/fix-the-als-clinical-trial-system/

       

      Richard

       

    • #19612
      Anonymous
      Inactive

      Diagnosis is a big factor in Clinical Trials. I mean, first, you are suspected of having ALS. Then they say it is possible. Then clinically possible to probable. Then clinically probable to definite. The time-lapse for this can be 12-18 months or more as in my case which was 3 years from symptom onset. Everybody is different, and the clinicians are all different, and the way they apply the modified El Escorial criteria is different. Yes, I have seen 5 different Neurologists, and they all have 5 different methods to evaluate neuromuscular symptoms.

      I get to wonder why they have so many levels to diagnose ALS. As it is, there is a 40% rate of misdiagnosed patients. Four out of 10 people are told they have something else when they have ALS. The rate of misdiagnosis for ALS is only 10%, or 1 out of 10 people who are told they have ALS actually have something else. The real quizzer is that 96% of those who are told they have probable ALS end up with a final definite diagnosis, so the probable diagnosis is an exercise in futility because on 4 out of 100 people who are diagnosed with probable ALS do not have it.  The probable criteria should be definite because they deny 96% of the probable diagnosed benefits that they should be getting.

      The Gold Coast criteria (GCC) for ALS diagnosis is better all around.  This is the Gold Coast criteria:

      1. progressive motor impairment documented by either history or repeated clinical assessment, preceded by normal motor function
      2. presence of UMN and LMN dysfunction in at least 1 body region (with UMN and LMN dysfunction noted in the same body region if only 1 body region is involved) or LMN dysfunction in at least 2 body regions
      3. exclusion of mimicking diseases by appropriate investigations.

      If this were the standard, the ability for researchers to include more people in clinical trials would be substantially increased.

      see this at

      EUH Morning Report: What is the diagnostic utility of Gold Coast Criteria in Amyotrophic Lateral Sclerosis (ALS)?

      • #19619
        Richard
        Participant

        Hi John, hope you were able to access the iamals website so that you could enter your viewpoint.

         

        Richard

         

        • #19647
          David Crellin
          Participant

          And carry out genetic testing every time.

          I had appointment with my GP, then referred to neurologist for probable then confirmed diagnosis from consultant before anyone took notice of me saying that my mother died with ALS. Bingo- I now know I inherited the C9orf72 gene mutation from her.

          If someone had listened & acted I would have been diagnosed six months earlier.

      • #19648
        David Crellin
        Participant

        Great if you live in the USA. The form doesn’t work for me in the UK.

    • #19630
      Anonymous
      Inactive

      I did! 🙂

       

       

      • #19635
        Richard
        Participant

        Perfect John!!

         

        Nothing changes if nothing changes.

         

        Richard

         

    • #19646
      David Crellin
      Participant

      1. Get rid of placebos, or at least review their use. The trial I’m hopefully about to enter involves lumbar punctures every three weeks for 40 weeks, with a 1/4 chance of a placebo. How anyone can affect their ALS progression or alter the repeats on their gene by imagining the stuff injected into their spine is real confounds me.

      2. Learn from Covid vaccine trials: run trials in parallel, not series.

      3. Speed up the academic review process.

      4. Apply some lessons from industry, including from the pharmaceutical industry. I observed Kaizen, Ishikawa, Lean and other tools at use in GSK. Try 5 Whys – ask ‘why?’ five times.

      5. Apply some skills from recruitment in business – don’t just rely on referrals from consultants. It was a chance listening to a BBC radio programme that led to me being invited into this new trial. I emailed the Prof about exercise and ALS. She emailed back next day about a trial starting in a few weeks. My consultant needed me sending him the details to get me referred. Turns out the Prof leading the trial studied with my sister & brother-in-law.

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