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  "notes": "The slide uses a 'villain' framing to discredit the reliability of clinical data originating from Russia and Eastern Europe.",
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      "kind": "callout",
      "text": "Studies and articles on fraud/integrity issues in foreign trials, particularly in Russia and Eastern Europe",
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      "text": "A Clinical Trial Torpedoed By Fraud and Incompetence",
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      "text": "As clinical trials have become a global enterprise, many observers have become increasingly worried about the integrity of data from certain geographic areas, in particular from Russia and other countries in the former Soviet Union. Now, a new paper published in the New England Journal of Medicine has provided “smoking gun”",
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      "text": "Recent studies have sounded warning bells about fraud and integrity issues in foreign trials especially in Eastern Europe, Russia, and other locations which played an oversized role in the pitolisant trials, particularly HARMONY CTP – “results from sites in Russia...cannot be trusted.” FDA Commissioner Robert Califf commented on similar findings published in the New England Journal of Medicine as “disturbing and it’s good to get it published...offshoring for financial reasons is bad because it raises risk of malfeasance.” A Stanford professor published a paper demonstrating that foreign trials are biased to deliver positive results and questioned “how much we can trust clinical evidence from these settings.” Several studies note wholesale fraud in clinical trials conducted in Russia – in one case, trial personnel simply sold the drug in the open market and patients who supposedly were administered it never actually got it.",
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      "text": "These numbers back up an earlier article which drew what has to be the most likely conclusion: that a significant number of patients in Russia and Georgia never ever got the drug. The Cardiobrief piece goes further, airing out the speculation that the spironolactone was, in fact, sold off on the open market by trial personnel rather than actually used as intended. That's the first thought that occurred to me, too - it had to go somewhere, right?",
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      "text": "“results from sites in Russia...cannot be trusted.” — FDA Commissioner Robert Califf. “disturbing and it’s good to get it published...offshoring for financial reasons is bad because it raises risk of malfeasance.” — FDA Commissioner Robert Califf. “how much we can trust clinical evidence from these settings.” — Stanford professor.",
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      "text": "Source: https://www.bmj.com/content/346/bmj.f707; http://www.cardiobrief.org/2017/04/26/serious-questions-raised-about-integrity-of-international-trials/; https://www.nejm.org/doi/full/10.1056/NEJmc1612601",
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