Spectrum News: Panama clinic autism #stemcell study w/o controls or blinding raises big concerns & resonates w/similar work at Duke, which also may require $$$ from some participants https://www.spectrumnews.org/news/experts-question-rationale-for-stem-cell-trial-for-autism/ … #stemcells Thoughts? @ejwillingham @CaulfieldTim @gorskon @aarondlevine
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Replying to @pknoepfler @ejwillingham and
Setting aside everything else, I have serious concerns about any pay to play “trial.” That’s 1 of the topics to be discussed at this upcoming meeting (https://www.hhs.gov/ohrp/sachrp-committee/meetings/2019-july-30-31-2019/index.html …). There’s a webcast
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Replying to @ABatemanHouse @pknoepfler and
Especially a poorly designed pay-to-play trial.
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Replying to @gorskon @ABatemanHouse and
*Any* pay-to-play trial. I don't care if it's an impeccably designed trial of a parachute drug -- volunteering one's body for an insufficiently-tested treatment is more than sufficient payment. If there's any payment, it should go the other way. (Which itself poses problems.)
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What if the study couldn't otherwise be done? (And it is well-designed, appropriate protections around clarity in consent, etc.)
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Replying to @HollyLynchez @cgseife and
That's a good point/question. My impression tho in this particular cord cell/autism sphere is that the studies are very limited such as no blinding or placebo controls.
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Replying to @pknoepfler @cgseife and
Nice piece just in my inbox relevant to this discussion: https://jamanetwork.com/journals/jama/fullarticle/2740057 …
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Replying to @HollyLynchez @cgseife and
In my opinion the Panama "trial" in question was/is uninformative, making it even less permissible to charge patients/families. I have some concerns about the Duke trial too w/o controls or blinding so far. I think they are going to strengthen moving forward tho so that's good.
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No controls/blinding=Worthless trial. ESPECIALLY for autism.
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