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      "text": "The problem with these trials and all trials of patients with rare conditions, and I suppose the Prader-Willi patient is the same when I've tried to recruit patients for other trials for Prader-Willi Syndrome, the ones who I think may benefit because they have got issues with weight gain and so on, are often the ones who are reluctant to participate in clinical trials.",
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      "kind": "paragraph",
      "text": "Not suitable for the 15 patients that could theoretically be prescribed the drug out of 40-50 total in the clinic; trial had inherent selection bias",
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      "text": "30-40% of older patients are diabetic; unsuitable for young patients as parents can manage the hyperphagia",
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      "text": "Q: “What did you make of the quality of the trial?” A: “The problem with these trials... you've got patients who are motivated... they're also motivated in managing their underlying condition... it's not just about a drug... 10 to 15 or so patients I have that may benefit from it probably weren't suitable for the trial.” -Trial investigator, endocrinologist, key opinion leader for PWS",
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      "text": "Q: “What percentage of PWS patients do you think are diabetic? What's your estimate, including the older ones?” A: “The older ones, probably about 30%, 40% because the older ones weren't managed as well... Q: “And what is your cut-off age?...” A: “Under ten, I don't think they need it because the parents are in control and their hyperphagia is managed.” -Trial investigator, endocrinologist, key opinion leader for PWS",
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      "text": "The problem with these trials and all trials of patients with rare conditions, and I suppose the Prader-Willi patient is the same when I've tried to recruit patients for other trials for Prader-Willi Syndrome, the ones who I think may benefit because they have got issues with weight gain and so on, are often the ones who are reluctant to participate in clinical trials. Whereas the ones who are already motivated are often keen to participate in trials. So, you have a kind of inherent selection bias. You've got patients who are motivated, who want to participate in trials, and because they're motivated, they're also motivated in managing their underlying condition. And as we've already mentioned, it's not just about a drug here for Prader-Willi Syndrome. There's lots of lifestyle, food security, etc., so your trial population is already biased to a certain degree. So, you've not got the maybe the most severe patients. I suppose that's where going back to my patient cohort, the 10 to 15 or so patients I have that may benefit from it probably weren't suitable for the trial. — Trial investigator, endocrinologist, key opinion leader for PWS",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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      "text": "Trial investigator #7 stated that the vast majority of PWS are simply not candidates for Vykat: patients under 10 are easily managed by parents who can keep the hyperphagia under control; and of the older patients, 30-40% are diabetic and inappropriate for the drug. He added that the PWS patients who need a drug the most are the ones with the least compliance and food security measures, making any drug ineffective.",
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