8 ms·

FDA is just too slow. Whole I’d like to do more radical reform, at a minimum this stupid long wait should be tossed. If someone hits a target endpoint auto appr

by mchusma 21d ago

FDA is just too slow. Whole I’d like to do more radical reform, at a minimum this stupid long wait should be tossed. If someone hits a target endpoint auto approval pending further review or something Remember in COVID when results. Came in and they took a month to schedule the meeting?

nottorp 21d ago
Self approval? Like Boeing?
- inglor_cz 21d ago
  Not self-approval, but maybe look at the clinical trial reforms in China (2016). There seems to be a lesson there to learn from. They made the trial system a lot more flexible, and China has recently overtaken the US in the # of new drugs patented, about a third worldwide. That number was ~ zero mere ten years ago.
- canucker2016 20d ago
  Is Boeing terminally ill? </rhetorical> Jake Seliger, HNer, jseliger - https://news.ycombinator.com/user?id=jseliger https://news.ycombinator.com/user?id=jseliger, who died a couple of years ago, had exhausted the current standards of treatment for head-neck cancer. Drugs available through clinical trials were his last option. But the workflow to access drugs via clinical trial is terrible. Directions/Instructions aren't documented. Unwritten limitations and optimizations. Jake and his wife documented his path through the process. see https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-cell-carcinoma-and-the-treatments-that-might-save-me-are-just-out-of-reach/ https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-ce... also see https://jakeseliger.com/tag/clinical-trials/ https://jakeseliger.com/tag/clinical-trials/ and https://bessstillman.substack.com/t/clinical-trial https://bessstillman.substack.com/t/clinical-trial Also read https://bessstillman.substack.com/p/the-seliger-act-testimony-for-a-new https://bessstillman.substack.com/p/the-seliger-act-testimon... for a literal post-mortem view of the clinical drug trial process.
  - inglor_cz 20d ago
    From the post-mortem. "The biggest bottleneck in the clinical trial system is recruitment and retention. It’s hard to get patients, and it’s hard to keep them." Yes, this was part of the Chinese reforms of 2016 that I mentioned in the next comment. I don't get why people just downvote things without learning more about them. Like China = always evil? No, they are an authoritarian system, but that does not mean that every single idea coming from them is bad or evil.

by mchusma 21d ago

nottorp 21d ago

Self approval? Like Boeing?

inglor_cz 21d ago
Not self-approval, but maybe look at the clinical trial reforms in China (2016). There seems to be a lesson there to learn from. They made the trial system a lot more flexible, and China has recently overtaken the US in the # of new drugs patented, about a third worldwide. That number was ~ zero mere ten years ago.
canucker2016 20d ago
Is Boeing terminally ill? </rhetorical> Jake Seliger, HNer, jseliger - https://news.ycombinator.com/user?id=jseliger https://news.ycombinator.com/user?id=jseliger, who died a couple of years ago, had exhausted the current standards of treatment for head-neck cancer. Drugs available through clinical trials were his last option. But the workflow to access drugs via clinical trial is terrible. Directions/Instructions aren't documented. Unwritten limitations and optimizations. Jake and his wife documented his path through the process. see https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-cell-carcinoma-and-the-treatments-that-might-save-me-are-just-out-of-reach/ https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-ce... also see https://jakeseliger.com/tag/clinical-trials/ https://jakeseliger.com/tag/clinical-trials/ and https://bessstillman.substack.com/t/clinical-trial https://bessstillman.substack.com/t/clinical-trial Also read https://bessstillman.substack.com/p/the-seliger-act-testimony-for-a-new https://bessstillman.substack.com/p/the-seliger-act-testimon... for a literal post-mortem view of the clinical drug trial process.
- inglor_cz 20d ago
  From the post-mortem. "The biggest bottleneck in the clinical trial system is recruitment and retention. It’s hard to get patients, and it’s hard to keep them." Yes, this was part of the Chinese reforms of 2016 that I mentioned in the next comment. I don't get why people just downvote things without learning more about them. Like China = always evil? No, they are an authoritarian system, but that does not mean that every single idea coming from them is bad or evil.