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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: 1, Flamebait) by khallow on Sunday May 03 2020, @10:58AM (7 children)

    by khallow (3766) Subscriber Badge on Sunday May 03 2020, @10:58AM (#989747) Journal
    I have to agree with the AC more or less. This isn't meaningless red tape, it's red tape that damns billions to earlier deaths. When it's more important to the regulators to avoid the risks of bad press from losing a few people in a bad study than to improve the lives of billions, you have to wonder if they are even delivering on that "science stuff" in the first place.
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  • (Score: 0, Troll) by Anonymous Coward on Sunday May 03 2020, @11:43AM (6 children)

    by Anonymous Coward on Sunday May 03 2020, @11:43AM (#989752)

    losing a few people in a bad study than to improve the lives of billions

    Try injecting that Clorox. I'm sure it will help

    I guess also you liked those Nazi experiments too. What is it, losing a few jews to improve the lives of the superior race?

    https://en.wikipedia.org/wiki/Nazi_human_experimentation [wikipedia.org]

    • (Score: 1) by khallow on Sunday May 03 2020, @12:28PM (5 children)

      by khallow (3766) Subscriber Badge on Sunday May 03 2020, @12:28PM (#989761) Journal
      I'll take your Clorox and Nazi experiments and raise you $300 epi-pens and a mere 11 year increase [infoplease.com] in life expectancy over the past 50 years.

      • (Score: 2) by MostCynical on Sunday May 03 2020, @08:59PM

        by MostCynical (2589) on Sunday May 03 2020, @08:59PM (#989905) Journal

        $300 epipen?

        Not [bloomberg.com] everywhere [corporatecrimereporter.com]

        --
        "I guess once you start doubting, there's no end to it." -Batou, Ghost in the Shell: Stand Alone Complex

      • (Score: 0) by Anonymous Coward on Monday May 04 2020, @02:24AM (3 children)

        by Anonymous Coward on Monday May 04 2020, @02:24AM (#990021)

        $300 epi-pens has nothing to do with trials. Epinephrine passed its trials decades ago. And patents on the early auto-injectors should have expired, since they date back to the early '80s.

        • (Score: 1) by khallow on Monday May 04 2020, @03:57AM (2 children)

          by khallow (3766) Subscriber Badge on Monday May 04 2020, @03:57AM (#990048) Journal

          $300 epi-pens has nothing to do with trials.

          Barrier to entry. [thehill.com] The cost of clinical trials and the FDA's regulatory maze go a long ways to making those prices possible. From the link:

          So why no competitors? A quick look at the market would find it’s not for lack of trying:

          • Auvi-Q, a “talking” autoinjector made by Sanofi, was recalled after patients reported receiving inaccurate doses of epinephrine, the drug injected through EpiPens.
          • Adrenaclick is on the market now, but isn’t considered “therapeutically equivalent” to EpiPen, which would make it more easily substitutable. (Adrenaclick was prescribed fewer than 100 times last year.)
          • EpiPen competitors are in development by pharmaceutical startups like Minneapolis-based AdrenaCard and Windgap Medical in Boston.

          What’s preventing competition is not lack of demand, but regulatory costs imposed by the Food and Drug Administration. One company estimates that it would cost them at least $1.5 million dollars to develop an EpiPen alternative and push it through clinical trials.

          • (Score: 0) by Anonymous Coward on Monday May 04 2020, @04:00AM (1 child)

            by Anonymous Coward on Monday May 04 2020, @04:00AM (#990049)

            So why are those companies trying to develop new auto-injectors rather than use older ones that were already approved?

            • (Score: 1) by khallow on Monday May 04 2020, @05:38AM

              by khallow (3766) Subscriber Badge on Monday May 04 2020, @05:38AM (#990076) Journal
              Don't know. I just know that $300 per EpiPen happens because someone doesn't have competition.