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Why are Clinical Trials So Complicated?

posted by martyb on Saturday May 02 2020, @09:12PM   Printer-friendly
from the festina-lente dept.

stormwyrm writes:

With a major pandemic sweeping the world, the standard process of clinical trials for drug approval has come under criticism as a needless source of bureaucracy and delay. Drug discovery chemist Derek Lowe in a blog post explains how clinical trials for drug approval work and the reasons behind the various requirements that the FDA and equivalent organisations around the world generally put in place before approving a new drug. He explains how most of these apparently pointless bureaucratic hurdles are actually there to help protect the integrity of the scientific process and ensure that the human subjects undergoing the trials are treated ethically. While a case can be made for relaxing some of these safeguards, especially in this time of pandemic, it is probably not a good idea to do so without at least understanding what these safeguards are for.

Determining how much of a pharmaceutical is needed to prepare for the trial. Ensuring your are actually preparing just that drug and not a polymorph. Proper laboratory and manufacturing practices to ensure the desired drug is actually prepared without impurities and contaminants. Preparing a plan for a drug trial. Demographics — age, gender, weight, current medications being taken. Getting a representative distribution of these as participants. And there's much more.

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  • (Score: 0) by Anonymous Coward on Sunday May 03 2020, @03:20AM (3 children)

    by Anonymous Coward on Sunday May 03 2020, @03:20AM (#989689)

    be careful.

    much of how we treat and know about hypothermia is from Mengele.

  • (Score: 0) by Anonymous Coward on Sunday May 03 2020, @09:58AM (2 children)

    by Anonymous Coward on Sunday May 03 2020, @09:58AM (#989735)
    That we might have got some useful science out of such unethical experiments still doesn't justify what they did. There is considerable controversy as to just how scientifically useful the results of these hypothermia experiments conducted by the Nazis really are, even setting aside their horrendous disregard for ethics. A review article [nejm.org] in the New England Journal of Medicine makes the case that there is actually scant useful science to be gleaned from the hypothermia experiments in any case, concluding: "On analysis, the Dachau hypothermia study has all the ingredients of a scientific fraud, and rejection of the data on purely scientific grounds is inevitable. They cannot advance science or save human lives." The other Nazi human experiments, such as the twin studies that were personally conducted by Mengele himself, are even more scientifically worthless.

    • (Score: 2) by driverless on Sunday May 03 2020, @12:34PM (1 child)

      by driverless (4770) on Sunday May 03 2020, @12:34PM (#989765)

      I don't think we'll ever really find out whether those studies were useful or not: Can you see the NEJM publishing a paper "Nazi Medical Research Was Actually Quite Useful In Some Cases"? Certainly after the war the Allies scrambled to get their hands on the Nazi study data, and former Unit 731 members were snapped up by the US, so there was obviously some use for it. "Totally unethical but now it's been done, may as well use it".

      • (Score: 0) by Anonymous Coward on Sunday May 03 2020, @02:29PM

        by Anonymous Coward on Sunday May 03 2020, @02:29PM (#989805)
        There are some medical ethicists (tellingly, some of them are even Jewish) who argue exactly that: if the data exists and can be used to save lives, then it would be unethical not to use it, despite its provenance. The thing is, much of the data that does exist and is available for public consumption is actually garbage. Do try to read the paper I cited by Dr. Berger. He makes little reference to the ethics of what Hauptsturmführer Sigmund Rascher had done in his hypothermia experiments at Dachau, and studies only the experimental data that is publicly available. He concludes that the data is disorganised, inconsistent, incomplete, and makes conclusions that are unsupported by the data that are available. Rascher was also a liar and a crook who among other misdeeds actually kidnapped babies and passed them off as his own (his wife was in her late forties and likely no longer able to bear children); for these and other crimes he was executed at Dachau just three days before the camp was liberated by the Allies.