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Interesting article on Medscape today about clinical trials. Key excerpt (my bolding):
Quote:
They also point out that it is a misconception that every clinical trial is testing a new cutting-edge therapy. In reality, a large portion of research is devoted to developing "me too" drugs, optimizing standard therapies, or repurposing drugs that have already been approved for another indication. From 2001 to 2010, fewer than half of all drugs that were approved by the US Food and Drug Administration involved first-in-class treatments.
Moderator cut: too long a quote. Read TOS
Last edited by SouthernBelleInUtah; 04-17-2018 at 10:00 PM..
Yes most new drugs starting trials never make it through to FDA approval - about 90% failure sounds right. Its even worse for some diseases.
When you consider that an even smaller percentage of potential drugs even get to the trial stage, the odds of a new molecule discovered in a lab becoming an FDA-approved drug and getting on commercial sale are very slim indeed.
An early trial is very small. It typically seeks to determine if a drug is safe and some parameters for dosing. Minimal stuff. A drug not making it past Phase 1 is not a big deal. They will retool it and try again in another Phase 1.
What is MORE important would be the percent of approvals at Phase 3 stage. Early trials aren't big money or investment for pharma. Phase 3 is.
An early trial is very small. It typically seeks to determine if a drug is safe and some parameters for dosing. Minimal stuff. A drug not making it past Phase 1 is not a big deal. They will retool it and try again in another Phase 1.
What is MORE important would be the percent of approvals at Phase 3 stage. Early trials aren't big money or investment for pharma. Phase 3 is.
How many tens or hundreds of millions in research, including basic research, to get to the point where something is even considered for a phase 1 trial, let alone further. Have you any concept of how much scientific research costs? Do you think its free? Multiple millions have been spent on multiple dead ends, false leads and failures before a lead molecule even gets to a Phase 1 trial. By Phase 3, the thousands of failures have already been filtered out. So its not "more important", it shows the Olympic medal contenders, who didn't make the cut before that point.
How many tens or hundreds of millions in research, including basic research, to get to the point where something is even considered for a phase 1 trial, let alone further. Have you any concept of how much scientific research costs? Do you think its free? Multiple millions have been spent on multiple dead ends, false leads and failures before a lead molecule even gets to a Phase 1 trial. By Phase 3, the thousands of failures have already been filtered out. So its not "more important", it shows the Olympic medal contenders, who didn't make the cut before that point.
So what you're saying is that it's the cost of doing business? If they don;t like the cost of doing business than do something else.
Not sure what your point your point is. Mine was that early trials are pretty inconsequential compared to later phase trials.
Or should we cover every 5 y old that lifts a golf club since he *might* be the next Tiger Woods and moan about how it didn't happen? Or just recognize that failure is PART of process and focus on end results? /shrug/
Frankly, if that stat is true, pharma needs better researchers.
The point of the article was that clinical trials are waaay over-sold to patients. The biggest driver, aside from drug companies, is the quest by medical centers for patient flow at the expense of patient hopes.
Put another way, patients seem to be the last consideration in clinical trial recruiting.
For those that still want to debate the clinical trial process, the oncology drug success rate Phase III to approval is 33%. Phase II to approval is 8.1%, according to reputable sources.
So what you're saying is that it's the cost of doing business? If they don;t like the cost of doing business than do something else.
Not sure what your point your point is. Mine was that early trials are pretty inconsequential compared to later phase trials.
Or should we cover every 5 y old that lifts a golf club since he *might* be the next Tiger Woods and moan about how it didn't happen? Or just recognize that failure is PART of process and focus on end results? /shrug/
Frankly, if that stat is true, pharma needs better researchers.
Alt-med fanatic that you are, your opinion on the abilities of dedicated and highly skilled PhD pharmaceutical researchers' abilities carries a lot of weight for sure. Rather than people who make up specious claims and have no accountability, nor testing of any sort, but whom you nevertheless hold in high regard.
The point is the failure rate of a potential (real) medicine is extremely high - due to the testing (not just clinical) that weeds out thousands and thousands of potentials before something is actually approved. The FDA approval that you are so dismissive of, compared to the open-mouth acceptance of untested "therapies"
Alt-med fanatic that you are, your opinion on the abilities of dedicated and highly skilled PhD pharmaceutical researchers' abilities carries a lot of weight for sure. Rather than people who make up specious claims and have no accountability, nor testing of any sort, but whom you nevertheless hold in high regard.
The point is the failure rate of a potential (real) medicine is extremely high - due to the testing (not just clinical) that weeds out thousands and thousands of potentials before something is actually approved. The FDA approval that you are so dismissive of, compared to the open-mouth acceptance of untested "therapies"
There's a reason that FDA doesn't require testing of supplements. Pretty easy to figure out.
And my opinion has no bearing on stats. IF the companies have THAT high a failure rate, they are doing something wrong. /shrug/
And YOU as a consumer should be really annoyed because it is driving up the cost of all your prescriptions.
[quote=newtovenice;51649715]
And my opinion has no bearing on stats. IF the companies have THAT high a failure rate, they are doing something wrong. /shrug/
/QUOTE]
Do you have any idea of what's involved in pharmaceutical research? Or for that matter, any kind of life science research? I think not, or you would not have made such a comment.
And my opinion has no bearing on stats. IF the companies have THAT high a failure rate, they are doing something wrong. /shrug/
/QUOTE]
Do you have any idea of what's involved in pharmaceutical research? Or for that matter, any kind of life science research? I think not, or you would not have made such a comment.
Yes, I do as a matter of fact. And there is a TON of wasted money there. Driving up the costs of all the drugs. And some of the new drugs which are being developed are not necessary and are NOT an improvement over the older drugs already on the market. So they are a complete waste of money.
Remember, drug companies are under no obligation to make a *better* product than what is already on the market. They just have to show it works better than placebo.
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