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Time to face reality: ‘No one is playing college football in the fall’
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BlazerMatt Offline
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Post: #146
RE: Time to face reality: ‘No one is playing college football in the fall’
This is how clinical trials work.

Phase 1
Does this drug treatment meet the minimum safety stands to test on humans. Usually takes a few months and involved a small number of people, less than 100 usually. Because they are testing for safety, they generally only test it on healthy volunteers.

Phase 2
For the first time you start looking at how effective the treatment is in a double blind study where usually 66% of your test subjects are getting the treatment and the remainder are getting a placebo. You are testing on sick people now, so you want the therapy to be given to as high a percentage as you can while still having a statistically significant control group. This stage can last anywhere from a few months to a couple of years and usually involves 300-500 test subjects. Just 30% of drugs make it past phase two either because they don't work or because they have dangerous side effects.

Phase 3
Once you have a treatment that has shown to be effective, you enter a phase three trial. Is it safe. Is it safe for men, women, pregnant women. kids. Does it have crazy interactions with other medication, including commonly used over the counter medications. As in phase two, you are testing on people who have the condition you are treating,but there are so many more variables you are testing for now you need many more volunteers and MUCH more time. Phase 3 trials usually last from 18 months to four years. Less than 30% of drugs that have made it this far survive phase 3 testing.

Phase 4
Ok, you have a medicine that seems to work in the short term. Seems to be safe in the short term. Seems to have an acceptable number and severity of side effects and adverse drug interactions in the short term. So now its time to track long term effects from a large population of people who have been receiving the treatment. Phase 4 involves thousands of people and lots of time. Skipping phase 4 is where we get a bunch of grim dystopian novels by the way. The book you read where there was some disease and the treatment wasn't tested properly and turned everyone into zombies, or made them sterile or caused everyone to become hyper aggressive and start killing each other, thats the fantasy version of skipping phase 4. The reality is that skipping or rushing phase four results in all of the commercials you see and hear from lawyers about how "XYZ has been recalled and has been proven to cause death or injury in people who used it. If you or a loved one have taken xyz in the past, call me at 1-800-I-SUE-NOW"

Whats happening now is that we are suggesting to rush through Phase 3 so quickly as to make it meaningless, and make the entire population of the US the subject of Phase 4.
(This post was last modified: 09-04-2020 09:47 AM by BlazerMatt.)
09-04-2020 09:35 AM
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RE: Time to face reality: ‘No one is playing college football in the fall’ - BlazerMatt - 09-04-2020 09:35 AM



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