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Ann: Treatment completed for all patients in Parkinsons trial, page-59

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Osgood

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05/05/17

19:01

Post #: 24508527
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Originally posted by whytee ↑

I'm pretty sure that only Barry Snow would have access to the patient assessments until the last patient to be treated has passed the 26 week milestone. He will of course be aware of the dose given to the group, since the date would give it away, but he wouldn't know whether or not a particular patient was a control.

Obviously the surgical team would know which patients had sham surgery and the DSMB would have access to all the patient data for safety reasons, and its likely blood samples would be tested for Porcine Retrovirus to make sure the patients haven't somehow been infected.

LCT would have probably not have access to even the unblinded data unless it was part of the protocol. Could be a good question to ask them. If the third group was improving far more quickly than the first, that would be a huge hint things would be good, even if you didn't know which patients had sham surgery. LCT wouldn't even be given the access to the post-op MRI scans since it would be easy to see the needle tracks from the procedure and determine whether a patient had sham surgery.

There are no PET scans being done on these patients. I did ask about that in an email, but it was apart of a series of questions that were all declined. Likely for cost reasons, and since most of the first 4 patients improved even without demonstrating increased brain dopamine concentrations on the PET scan. I did ask if they intended to revisit PET scanning later.

I can't really see why they couldn't unblind each batch after the 6 months were up, although the sham surgical patients would have to wait until the end of the trial to recieve their offered optimum treatment. It would have made sense if they were all recieving randomised doses, but that isn't the case. Possibly they could be afraind of introducing bias. If Barry Snow knew for sure that the implants had worked in the first batch, it might impact his assessments of the second and third groups. At the moment he's supposed to suspend judgement, but if it works well it could be clinically obvious already.

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Whytee and Joules, thank you both, very informative and much appreciated.

LCT Price at posting: 11.0¢ Sentiment: Buy Disclosure: Held
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