Dropping slow process in early clinical trials would make medicines available sooner

Dropping slow process in early clinical trials would make medicines available sooner

  • Takatakatakatakatak@lemmy.dbzer0.comEnglish
    171·
    8 months ago

    I know enough to believe this isn’t a great idea.

    Genetic variation in target populations can result in different outcomes for a variety of treatments and is worth testing specifically.

    • AggressivelyPassive@feddit.de
      31·
      8 months ago

      Is it, though?

      How likely is it that there’s a relevant outcome vs. how likely will the massively delayed introduction of a drug (or no introduction at all) harm someone?

      It’s not like Japanese are aliens.

      • Takatakatakatakatak@lemmy.dbzer0.comEnglish
        10·
        8 months ago

        https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2976712/

        It’s significant. Biggest effect is on efficacy of drug metabolism. There are many such studies.

        One size does not fit all here owing to differences in expression of metabolising enzymes and drug transport mechanisms.

        No, the Japanese are not aliens but they may require far less of a given drug than a westerner, or far more. This affects the likelihood to experience side effects for any given compound, and their severity.

        It’s fairly ironic to make this change for Japan whilst elsewhere in the world with more racially mixed populations there has been a push in the opposite direction: a recognition that you cannot assume the results of a trial carried out on white male subjects will apply to those of African descent for example.

        It’s not just drug treatments either. There are many aspects of medical care which have suffered from a lack of specificity and systemic bias.

        • regul@lemm.ee
          2·
          8 months ago

          Wouldn’t Japan have decades of data to analyze, though? Comparison of the global vs Japanese trials, any detected differences once released, etc. It’s not like they’re making this decision blind.

        • otp@sh.itjust.works
          1·
          7 months ago

          It’s significant, sure. But it might be better to let the companies bring the drugs in, and any skeptics can wait for any news if they choose.

          If I recall, this lengthened the impact of covid because they delayed the vaccines.

  • AutoTL;DR@lemmings.worldBEnglish
    2·
    8 months ago

    This is the best summary I could come up with:

    The policy change is expected to lower barriers for foreign pharmaceutical companies, making their new drugs accessible in Japan as soon as possible.

    The Ministry of Health, Labor and Welfare says this is intended to ensure safety for people living under the conditions found in Japan.

    In order to improve the situation, the health ministry will soon issue a new notice stating that additional testing of Japanese nationals is not required in principle.

    The ministry has decided that the safety of drugs in Japanese patients can be confirmed in Phase 3 even if earlier additional studies are eliminated.

    In response to the health ministry’s hearing, one pharmaceutical company commented, “Clinical trials for Japanese patients are a barrier to introducing new drugs.”

    A Western pharmaceutical company also noted, “The necessity of [additional testing] is not fully explained, and our headquarters does not understand it.”

    The original article contains 558 words, the summary contains 143 words. Saved 74%. I’m a bot and I’m open source!