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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, Touché) by Anonymous Coward on Saturday May 02 2020, @09:24PM (3 children)

    by Anonymous Coward on Saturday May 02 2020, @09:24PM (#989588)

    And then after the trials are complete and the FDA gives approval, you may inject the bleach in the lungs.

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  • (Score: 1, Informative) by Anonymous Coward on Saturday May 02 2020, @11:12PM (2 children)

    by Anonymous Coward on Saturday May 02 2020, @11:12PM (#989627)

    Only using the patented process of course.

    • (Score: 0) by Anonymous Coward on Sunday May 03 2020, @01:35AM (1 child)

      by Anonymous Coward on Sunday May 03 2020, @01:35AM (#989663)
      I wonder why people keep harping on "patents". It's not like it's all that hard for a pharma company to make an obscene profit even on drugs whose patents have expired. Purdue Pharma is a case in point. They made billions with opiate drugs like oxycodone, which was discovered more than a century ago.

      • (Score: 2) by Muad'Dave on Monday May 04 2020, @12:48PM

        by Muad'Dave (1413) on Monday May 04 2020, @12:48PM (#990156)

        Then why have they extended the patent 13 times, out to 2030 [qz.com]?

        Purdue Pharma is the company behind one of the most popular prescription opioids. OxyContin first came on the market in 1996 and has since brought in billions of dollars of revenue. Purdue’s patent for OxyContin was originally supposed to expire in 2013. But by making minor tweaks to the drug’s chemical structure to create a slow-release pill the company markets as “abuse-proof,” Purdue has been able to file new patents for OxyContin 13 times with the US Patent and Trademark Office over the past decade, thereby extending its exclusive selling rights on the drug through 2030.