3 ms·

1) Any extra funds can only help. 2) And thus the humanitarian part of the trial can serve dual purpose as a training exercise for the additional physicians wo

1) Any extra funds can only help. 2) And thus the humanitarian part of the trial can serve dual purpose as a training exercise for the additional physicians working with the humanitarian cohort.

ethanbond 3y ago
Extra funds for extra complexity? No pharma company will take that trade. Trials aren’t humanitarian efforts.
- anonymouskimmer 3y ago
  What kind of extra complexity other than just manufacturing more treatments? A lot of any extra complexity should be handled by the additional patient's medical providers anyway. Depending on the rarity of the illness, this may be something that the government can easily force pharma companies to accept. They accept far more in regulatory burden and still do business.
  - ethanbond 3y ago
    Do you think standard of care already includes collecting the vast amount of data required to understand a treatment's effects? Medical providers aren't trained to execute clinical trials. They can do bits and pieces, but they still need extremely strong, close oversight from an actual researcher. Someone ultimately has to hold liability for trial participants too, and no one is going to take on the liability of an untrained care provider to administer a trial to a patient. Additionally, the pharma company wouldn't allow this because in addition to the upfront design complexity, it would put the trial itself at risk. You're not really allowed to say, "just try it in a bunch of people, it's okay if untrained folks mess it up because if they do we can just throw out the data."
    - anonymouskimmer 3y ago
      I addressed this in a comment here: https://news.ycombinator.com/item?id=39247715 https://news.ycombinator.com/item?id=39247715
      - ethanbond 3y ago
        What did you address? It sounds like you're just saying to give the drug away for free to another cohort of people who will be producing totally useless and incomparable data. Not opposed to that, but it's not a study cohort. It's just "give investigational drug away for free."
        anonymouskimmer 3y ago
        > What did you address? This part: > You're not really allowed to say, "just try it in a bunch of people, it's okay if untrained folks mess it up because if they do we can just throw out the data." --- > It's just "give investigational drug away for free." And here insurance regulation can also come in to play along with the pharma regulation. Sure, none of this would be easy. But the status quo has issues too.

1) Any extra funds can only help. 2) And thus the humanitarian part of the trial can serve dual purpose as a training exercise for the additional physicians working with the humanitarian cohort.

ethanbond 3y ago

Extra funds for extra complexity? No pharma company will take that trade. Trials aren’t humanitarian efforts.

anonymouskimmer 3y ago
What kind of extra complexity other than just manufacturing more treatments? A lot of any extra complexity should be handled by the additional patient's medical providers anyway. Depending on the rarity of the illness, this may be something that the government can easily force pharma companies to accept. They accept far more in regulatory burden and still do business.
- ethanbond 3y ago
  Do you think standard of care already includes collecting the vast amount of data required to understand a treatment's effects? Medical providers aren't trained to execute clinical trials. They can do bits and pieces, but they still need extremely strong, close oversight from an actual researcher. Someone ultimately has to hold liability for trial participants too, and no one is going to take on the liability of an untrained care provider to administer a trial to a patient. Additionally, the pharma company wouldn't allow this because in addition to the upfront design complexity, it would put the trial itself at risk. You're not really allowed to say, "just try it in a bunch of people, it's okay if untrained folks mess it up because if they do we can just throw out the data."
  - anonymouskimmer 3y ago
    I addressed this in a comment here: https://news.ycombinator.com/item?id=39247715 https://news.ycombinator.com/item?id=39247715
    - ethanbond 3y ago
      What did you address? It sounds like you're just saying to give the drug away for free to another cohort of people who will be producing totally useless and incomparable data. Not opposed to that, but it's not a study cohort. It's just "give investigational drug away for free."
      - anonymouskimmer 3y ago
        > What did you address? This part: > You're not really allowed to say, "just try it in a bunch of people, it's okay if untrained folks mess it up because if they do we can just throw out the data." --- > It's just "give investigational drug away for free." And here insurance regulation can also come in to play along with the pharma regulation. Sure, none of this would be easy. But the status quo has issues too.