4 ms·

FDA approving drugs after fewer trials, providing less information to public

45 points by JPLeRouzic 3y ago

sshine 3y ago
> Of the 37 drugs approved by the FDA in 2022, 24 (about 65%) were approved based on a single study. If consumers could more easily evaluate the extent of testing a drug was exposed to, they could make an informed decision as to whether they want to be the testers. It would incentivise drug makers to test, or at least try to inflate this.
- runnerup 3y ago
  I use clinicaltrials.gov extensively to evaluate pharmaceutical options. It’s frustrating how many trials have completed years ago but have no results posted.
  - HWR_14 3y ago
    Isn't the idea that as new trials are completed, the data gets entered. Just like how old buildings are only brought up to code when work is being done anyway? So old trials may never catch up with it.
    - reaperman 3y ago
      I think meant like 2-3 years...for which they've most definitely had enough time to process the results.
haunter 3y ago
[flagged]
- runnerup 3y ago
  I’m honestly impressed at just 4 words can go against so many HN commenting guidelines. Be kind. Don't be snarky. Converse curiously; don't cross-examine. Edit out swipes. Comments should get more thoughtful and substantive, not less, as a topic gets more divisive. Eschew flamebait. Avoid generic tangents. Omit internet tropes. Please don't post shallow dismissals, especially of other people's work. A good critical comment teaches us something. Please don't use Hacker News for political or ideological battle. That tramples curiosity.
magwa101 3y ago
[dead]
stevespang 3y ago
[dead]
thenerdhead 3y ago
> "The purpose of ClinicalTrials.gov was to have a way for the non-scientific community to access the trials and their results, in a way that people can understand." This is a real problem. So many trials don't post their results nor provide updates to the trial status. They just register the trial as that is what is required by the FDA. You still have the challenges of drug trial scandals, funding concerns, etc. The whole point is that trials are registered, report findings from the trials, and are immutable. Many of these trials however are mutable with post-hoc findings. Someone at the end of the day has to enforce the rules and articles like this seem to show there is not much enforcement going on and even less trials are published because of it. https://www.bmj.com/content/352/bmj.i637 https://www.bmj.com/content/352/bmj.i637
- InSteady 3y ago
  >Conclusions Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers. Sheesh.

45 points by JPLeRouzic 3y ago

> Of the 37 drugs approved by the FDA in 2022, 24 (about 65%) were approved based on a single study. If consumers could more easily evaluate the extent of testing a drug was exposed to, they could make an informed decision as to whether they want to be the testers. It would incentivise drug makers to test, or at least try to inflate this.

runnerup 3y ago
I use clinicaltrials.gov extensively to evaluate pharmaceutical options. It’s frustrating how many trials have completed years ago but have no results posted.
- HWR_14 3y ago
  Isn't the idea that as new trials are completed, the data gets entered. Just like how old buildings are only brought up to code when work is being done anyway? So old trials may never catch up with it.
  - reaperman 3y ago
    I think meant like 2-3 years...for which they've most definitely had enough time to process the results.

haunter 3y ago

[flagged]

runnerup 3y ago
I’m honestly impressed at just 4 words can go against so many HN commenting guidelines. Be kind. Don't be snarky. Converse curiously; don't cross-examine. Edit out swipes. Comments should get more thoughtful and substantive, not less, as a topic gets more divisive. Eschew flamebait. Avoid generic tangents. Omit internet tropes. Please don't post shallow dismissals, especially of other people's work. A good critical comment teaches us something. Please don't use Hacker News for political or ideological battle. That tramples curiosity.

magwa101 3y ago

[dead]

stevespang 3y ago

[dead]

thenerdhead 3y ago

> "The purpose of ClinicalTrials.gov was to have a way for the non-scientific community to access the trials and their results, in a way that people can understand." This is a real problem. So many trials don't post their results nor provide updates to the trial status. They just register the trial as that is what is required by the FDA. You still have the challenges of drug trial scandals, funding concerns, etc. The whole point is that trials are registered, report findings from the trials, and are immutable. Many of these trials however are mutable with post-hoc findings. Someone at the end of the day has to enforce the rules and articles like this seem to show there is not much enforcement going on and even less trials are published because of it. https://www.bmj.com/content/352/bmj.i637 https://www.bmj.com/content/352/bmj.i637

InSteady 3y ago
>Conclusions Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers. Sheesh.