3 ms·

It appears it didn’t work. If you’re dog and ponying your new treatment, and the best you can say is “the side effects resolved on their own,” you have to assu

It appears it didn’t work. If you’re dog and ponying your new treatment, and the best you can say is “the side effects resolved on their own,” you have to assume the efficacy was disappointing.

GeekyBear 3y ago
Testing for safety only at first is just following the normal procedure. > Researchers conduct clinical trials in a series of steps called phases. Phase I trials: Researchers test a medicine or other treatment in a small group of people for the first time. The purpose is to learn about the best dosage for a medicine or other treatment and to learn about the safety and side effects. Phase II trials: Researchers study the new medicine or treatment in a larger group of people to determine its effectiveness and to further study its safety. Phase III trials: Researchers give the new medicine or treatment to an even larger group of participants to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments or a placebo , and collect information that will allow the new medicine or treatment to be used safely. Phase IV trials: After the U.S. Food and Drug Administration (FDA) approves a medicine or treatment and it is made available to the public, researchers track its safety in the general population, seeking more information about the medicine or treatment’s benefits and optimal use. https://www.nhlbi.nih.gov/research/clinical-trials/how-studies-work https://www.nhlbi.nih.gov/research/clinical-trials/how-studi...
- tiahura 3y ago
  Understood, however they know if it worked or not, and nothing prohibits them from announcing that it worked.
  - opprobium 3y ago
    I agree with your logic that if they got surprisingly good efficacy results they would have reported it, but the Phase I participants received a much smaller dose than the planned actual treatment. It would have been great if the treatment had clinical efficacy at even the safety dosing level, but it's also not especially disappointing that it didn't.

GeekyBear 3y ago

Testing for safety only at first is just following the normal procedure. > Researchers conduct clinical trials in a series of steps called phases. Phase I trials: Researchers test a medicine or other treatment in a small group of people for the first time. The purpose is to learn about the best dosage for a medicine or other treatment and to learn about the safety and side effects. Phase II trials: Researchers study the new medicine or treatment in a larger group of people to determine its effectiveness and to further study its safety. Phase III trials: Researchers give the new medicine or treatment to an even larger group of participants to confirm its effectiveness, monitor side effects, compare it with standard or similar treatments or a placebo , and collect information that will allow the new medicine or treatment to be used safely. Phase IV trials: After the U.S. Food and Drug Administration (FDA) approves a medicine or treatment and it is made available to the public, researchers track its safety in the general population, seeking more information about the medicine or treatment’s benefits and optimal use. https://www.nhlbi.nih.gov/research/clinical-trials/how-studies-work https://www.nhlbi.nih.gov/research/clinical-trials/how-studi...

tiahura 3y ago
Understood, however they know if it worked or not, and nothing prohibits them from announcing that it worked.
- opprobium 3y ago
  I agree with your logic that if they got surprisingly good efficacy results they would have reported it, but the Phase I participants received a much smaller dose than the planned actual treatment. It would have been great if the treatment had clinical efficacy at even the safety dosing level, but it's also not especially disappointing that it didn't.