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Posts tagged with "Clinical Trials"

  • Clinical Trials

    Comparing HydroxyChloroquine Trials

    One minor side effect of the pandemic is that perhaps more people will learn about what drug research and clinical trials can really be like. Today’s example: we have a clinical trial of hydroxychloroquine from Wuhan that has just published on a preprint server. What’s good is that this one is blinded, randomized, and controlled… Read More
  • Clinical Trials

    More on Chloroquine/Azithromycin. And On Dr. Raoult.

    Dr. Didier Raoult of Marseilles and his co-workers have published another preprint on clinical results with the chloroquine/azithromycin combination that their earlier work has made famous. And I still don’t know what to think of it. This is going to be a long post on the whole issue, so if you don’t feel like reading… Read More
  • Clinical Trials

    The Latest Coronavirus Clinical Trials

    Time to catch up with the latest clinical news in the field. The big story this morning is apparently some real data out of a controlled trial of chloroquine from China. There have been anecdotal reports, but to the best of my knowledge we have seen no actual numbers. These are not exactly from the… Read More
  • Clinical Trials

    Crossing Fingers

    I’ve mentioned it in passing before, but it bears repeating: this is a really unusual moment in drug discovery. We have simultaneously more new modes of action for therapy coming on in the clinic than I can ever recall, and some older ones are getting reworked to join the action. This short overview is a… Read More
  • Clinical Trials

    Idiosyncratic Tox

    It’s our high failure rate in clinical trials that makes the drug industry what it is. And two of the biggest factors in that failure rate are picking the wrong targets/mechanisms, and unexpected toxicity. The first is clearly a failure of our understanding of human biology, and the only remedy I can see for that… Read More
  • Clinical Trials

    Drug Dosing

    First in humans! That’s a big step for a drug project – you’ve identified a clinical candidate with enough potency, selectivity, etc. to be a plausible drug, you’ve made it past toxicity testing (always a black-box cross-your-fingers exercise), and you’ve figured out a way to dose the stuff in human subjects. But how d… Read More
  • Alzheimer's Disease

    A Prospective Alzheimer’s Trial Reports

    For the past several years, a clinical trial from Washington University (St. Louis) has been underway in people with genetic mutations that lead to early-onset Alzheimer’s. The Dominantly Inherited Alzheimer’s Network (Trials Unit), DIAN-TU, has been dosing 194 such patients with one of two anti-amyloid antibodies, either Lilly’s… Read More
  • Clinical Trials

    Opening the Lid on Sarepta’s Drug Approvals

    Let’s talk Sarepta. And FDA approval, because you can’t bring up that company without immediately starting a regulatory affairs argument. I was not happy when their initial exon-skipping therapy (Exondys, eteplirsen) for Duchenne muscular dystrophy was approved in 2016, because I thought that the efficacy data were simply not strong eno… Read More
  • Academia (vs. Industry)

    Getting Around to Reporting Clinical Data, Real Soon Now

    Science has an interesting report on the publication of clinical trial results. Some readers will recall similar efforts from 2015 and 2017/2018 in the US and Europe; this is actually a follow-up by one of the same US authors. It should actually be a dull report, because the requirements for such disclosure are clear. The rules… Read More
  • Alzheimer's Disease

    They Don’t Know

    Well, Biogen has released more data on its Alzheimer’s antibody, aducanumab. The people (like me) who were doubtful (or worse) that they had enough to make a case for FDA approval remain doubtful. And the people (there are some) who think that it’s approvable haven’t changed their minds, either, from what I can see. Frankly… Read More
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