requiring registering with clinicaltrials.gov and regulators doing their own analysis on all the data.
Managed entry agreements and conditional reimbursement (dont pay for patients that dont do better than the average of current practice)
Requirements for "real world data" collection and submission post approval.
A whole host of other mechanisms I cant remember off the top of my head.
Also
"evidence based medicine" doesnt mean the evidence is infallible (e.g. rare disease meds have a huge issue with collecting any meaningful data) - it just means actually using evidence rather than just taking the industries and acedemias word for it that it works like the old days.
I've worked with nice. several of my students still do. We've kicked out of the NHS quite a few meds the industry and academics were wrong about, based on the evidence, not what the industry/academics said before they were shown to be not correct.
The whole posit of this article is wrong. "acedemics said so" is not evidence based medicine, it is one small facit of it, and the author matters, no one trusts "sponsored by" papers, NIHR is constantly publishing counter evidence. Some of that even ends up in court (e.g. Avastin)
This I totally agree with. I've not much experience with the UK system, but I disagree that publication bias is solved, at least regarding the scientific literature at large.
Well. I guess you could probably pin some blame on publication bias for the massive misinvestment that went into the recent dementia meds that all failed at phase 3. Something made them get the science badly wrong.
I was talking specifically in the context of evidence based medicine for regulatory decision making, which is the process that replaced blue envelopes full of money or throwing acedemic papers at an important politician whose relative had the disease that came before it.
They are "fixed" by extending the evidence base for decision making well beyond raw clinical trial data and publications on them (none of which ever translates into real world practice outcomes anyway).
In important instances (such as expensive meds going to large numbers of people) the payer will commission their own research e.g. through NIHR
https://www.nihr.ac.uk/
There is a whole field of "value of information" now to estimate how incorrect information would affect a decision and whether it warrants research investment (which covers publication bias - e.g. how many unpublished studies showing no or negative effects would there need to be to change the decision)
Managed entry agreements and conditional reimbursement (dont pay for patients that dont do better than the average of current practice)
Requirements for "real world data" collection and submission post approval.
A whole host of other mechanisms I cant remember off the top of my head.
Also
"evidence based medicine" doesnt mean the evidence is infallible (e.g. rare disease meds have a huge issue with collecting any meaningful data) - it just means actually using evidence rather than just taking the industries and acedemias word for it that it works like the old days.