ALS News Today Community Forums ALS Progress Research Topics Phases of Clinical Research – ALS treatments

  • Phases of Clinical Research – ALS treatments

    Posted by MG Community Member on September 27, 2021 at 7:26 am

    “The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment.[1] For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective.[1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.”

    https://en.wikipedia.org/wiki/Phases_of_clinical_research

    Understanding the phases of clinical research

    MG Community Member replied 4 years, 7 months ago 3 Members · 3 Replies
  • 3 Replies
  • MG Community Member

    Member
    September 28, 2021 at 4:52 pm

    These phases don’t even mention the phase of timing releases of information to investors. I believe phases are timed to maximize investors increasing the stock price of these development companies. A fast trial and weak results not too great for bottom line.

    • MG Community Member

      Member
      September 29, 2021 at 11:39 am

      You are right, it does not mention anything about investors because that wasn’t what I was searching for.

  • MG Community Member

    Member
    October 6, 2021 at 9:46 am

    Interestingly the trial I’m about to start is a Phase 1b/2a first-in-human trial. Progress & dosing regimen in Phase 2b is dependent on safety & efficacy results from Phase 1b. Some participants will skip Phase 1b.

    For better or worse, as the first participant I’m a sentinel. I have more intensive monitoring, but also a greater chance of placebo. Why?????

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