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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 6 of 6. This is the beginning of the thread.
Posted by Jay2112 on October 6, 2021, at 15:30:35
I was looking through a number of research data sets on new drugs in psychiatry. It seems that often, real world data shows better efficacy than clinical trials.What I do and don't understand is why and how approval of new drugs are not given say a temporary 5 year approval to collect real world data, which in a number of cases for approved drugs, comes out quite differently than the clinical trial data.
So, say safety is the major factor in a temporary approval, and efficacy is so/so, if real world data comes back with better efficacy than the clinical trials, then it would get permanent approval?
Research into new drugs in psychiatry and approval rates are at the bottom say, compared to drugs in cancer research. Let's say the amount of dollars into research to bring a psychiatric drug to approval was cut by 20 percent, as long as safety is not compromised, get the drug out, and let the real world data determine it's further efficacy, and then get an approval or denial.
Point is, we need MANY more drugs, some/most of different mechanisms than current psychiatric drugs. All of us agree???
Posted by undopaminergic on October 6, 2021, at 17:10:04
In reply to Real World data and new drugs, posted by Jay2112 on October 6, 2021, at 15:30:35
> [about tentative approval of drugs to allow
> collection of real-world efficacy data]Good ideas!
>
> Point is, we need MANY more drugs, some/most of different mechanisms than current psychiatric drugs. All of us agree???
>Yes. Many drugs that are used in research (especially neuroscience) should, in my opinion, be available for clinical use. Ritanserin and JDTic are a couple of excellent examples.
-undopaminergic
Posted by SLS on October 6, 2021, at 22:30:22
In reply to Real World data and new drugs, posted by Jay2112 on October 6, 2021, at 15:30:35
I post regularly regarding the higher rate of reported placebo effect and lower rate of efficacy as reported in today's antidepressant clinical trials compared to those conducted in the 1970s and 1980s. To explain this, one must take into consideration the differences in subject selection and inclusion criteria. Today's trials dilute the subject population by including subjects who do not really have Major Depresive Disorder. They are experimenting using people who don't really have the illness that they are supposed to be studying.
Oh, well.
Money.
Investigators are paid by the numbers of participants they recruit.
- Scott
Posted by undopaminergic on October 7, 2021, at 10:31:17
In reply to Re: Real World data and new drugs, posted by SLS on October 6, 2021, at 22:30:22
> I post regularly regarding the higher rate of reported placebo effect and lower rate of efficacy as reported in today's antidepressant clinical trials compared to those conducted in the 1970s and 1980s. To explain this, one must take into consideration the differences in subject selection and inclusion criteria. Today's trials dilute the subject population by including subjects who do not really have Major Depresive Disorder. They are experimenting using people who don't really have the illness that they are supposed to be studying.
>
> Oh, well.
>
> Money.
>
> Investigators are paid by the numbers of participants they recruit.
>
>
> - ScottMoney? Isn't there more money to be made from showing efficacy of the drug? So, they would want to choose subjects that will respond better to the drug, wouldn't they?
-undopaminergic
Posted by SLS on October 7, 2021, at 18:06:48
In reply to Re: Real World data and new drugs, posted by undopaminergic on October 7, 2021, at 10:31:17
> > I post regularly regarding the higher rate of reported placebo effect and lower rate of efficacy as reported in today's antidepressant clinical trials compared to those conducted in the 1970s and 1980s. To explain this, one must take into consideration the differences in subject selection and inclusion criteria. Today's trials dilute the subject population by including subjects who do not really have Major Depresive Disorder. They are experimenting using people who don't really have the illness that they are supposed to be studying.
> >
> > Oh, well.
> >
> > Money.
> >
> > Investigators are paid by the numbers of participants they recruit.
> >
> >
> > - Scott
>
> Money? Isn't there more money to be made from showing efficacy of the drug? So, they would want to choose subjects that will respond better to the drug, wouldn't they?
>
> -undopaminergic
UD,The clinical trial company gets paid by the number of subjects they recruit. They really don't give a damn whether the drug works or not, as long as they get paid and their contract renewed.
-----
Prospective participant: "I'm depressed."
Screening coordinator: "Okay. That's good enough. You are definitely eligible for our study. Just sign this paper."
-----
- Scott
Posted by undopaminergic on October 8, 2021, at 11:00:48
In reply to Re: Real World data and new drugs, posted by SLS on October 7, 2021, at 18:06:48
> >
> > Money? Isn't there more money to be made from showing efficacy of the drug? So, they would want to choose subjects that will respond better to the drug, wouldn't they?
> >
> > -undopaminergic
>
>
> UD,
>
> The clinical trial company gets paid by the number of subjects they recruit. They really don't give a damn whether the drug works or not, as long as they get paid and their contract renewed.
>
> -----
>
> Prospective participant: "I'm depressed."
>
> Screening coordinator: "Okay. That's good enough. You are definitely eligible for our study. Just sign this paper."
>
> -----
>OK, but the sponsoring pharmaceutical company *does* give a damn whether their drug gets approved, so why would they hire a clinical trial company that does not maximise the chance of approval?
-undopaminergic
This is the end of the thread.
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