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To Control or Not Control
I was diagnosed with ALS on Oct. 15th, 2021. I started noticing leg muscle weakness in June of that year. I had experienced severe muscle cramping the year before that.
Early 2022, I started participating in a clinical trial for AMX0035 at Emory in Atlanta, which is one of multiple testing sites. With this clinical trial, 60% of the participants receive AMX0035 and 40% receive a placebo. Of course, a control group taking a placebo is required so the effectiveness of AMX0035 can be measured. Is that old thinking that we learned in high school science classes?
I would suggest that a study should be conducted comparing the results across control groups for past ALS clinical trials across multiple teaching hospitals. If the results are comparable, couldn’t past control group results be used as the control group when testing new medications to treat ALS? This would allow more people to receive the experimental medication. This thinking is really an extension of the Healy ALS Platform studies going on now. This is where multiple clinical trials use one control group for the multiple medications being tested.
Another thought is for those people with ALS who choose not to or cannot participate in a clinical trial, could their progression results be submitted by their doctor to some entity and could be used as the control group in new clinical trials?
ALS is a formidable disease where no meaningful medication has yet been found to significantly slow, stop or reverse the progression of ALS. We need revised thinking on how to test new medications at a faster pace and at lower costs. More people taking an experimental medication, as opposed to a placebo, would accelerate the testing process, lower costs and reduce barriers for new medications reaching clinical trial status.
What are your thoughts? Varying opinions are just as important as my thoughts noted above.
My best to you! Curt Vong
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