tom p wrote: ↑Fri Mar 19, 2021 11:08 am
shpalman wrote: ↑Fri Mar 19, 2021 9:40 am
tom p wrote: ↑Fri Mar 19, 2021 9:19 am
I get your point, however there is a very good reason why there is zero chance of people outside ever being invited into these meetings to witness the discussions.
I wouldn't have expected that. I expected something more like the link you give below, except with some graphs or tables of data or something.
The past year has seen a lot of opening up of access, both in terms of real-time statistics on government websites, and in terms of preprints of scientific publications. Within the limits of industrial intellectual property protection and patient confidentiality I'd like to see the same from medicine regulators.
(The approval process seemed to go like "vaccine submitted to regulator and expected to be approved by [date]" "[date]: yep it's approved" as if the regulator just gives a meaningless rubber stamp to whatever the drug company says, and not a whole load of detailed rules and guidelines about how [and how not] to produce, transport, store, and administer the vaccine. Please explain this to us, because nobody else seems to be doing it.)
That's an interesting question.
Normally the expectedness of approval is far less certain. I will reply later about this, 'cos i want to give a full answer without writing too much.
Normal drug approvals process:
1. academic identifies possible cause of a disease - e.g. a dodgy receptor on a cell surface
2. companies read about this and rush to synthesise the faulty receptor & then run their massive banks of hundreds of thousands of chemicals & proteins against it. In parallel, they look at synthesising things which will mimic what should bind with it & then try those.
3. anything that shows some form of binding with the receptor is then (a) patented & (b) studied to death through many phases of pre-clinical trials (lab & then animals)
4. companies then look at what has been patented by others & copy that, but adding a slight twist & study that too
5. the top 100 or so candidates go into phase 1 trials with healthy volunteers (all youngish blokes: students, unemployed & backpacking aussies who are happy to swap a bit of blood to be paid 2 grand to spend a week playing playstation)
6. the top 10 or so go into phase 2 trials (hopeless cases who all other drugs have failed)
7. the top 1 to 3 go into phase 3 trials.
8. early phase 3 trial results whittle it down to the best 1
8a. if things are looking good, then company starts to focus on manufacturing and storage details. They were obviously caring about it before, but now it ramps up.
9. company sends all their data to the regulators (following the guidance
here - summat the RDIF should have read, the dozy twonks) & crosses their fingers
10. bit of back and forth between regulators and company to clarify any questions the regulators have (
here's a list of basic validation issues frequently found - the potential issues with the actual data are far greater)
11. committee meeting when the regulators decide whether or not to grant a license and, if so, under what conditions.
Steps 1-9 take 12-15 years and cost $250 to 1,000 million. Steps 10 & 11 take 9-18 months depending on how many questions the regulators have.
A far better & more thorough overview is available
here
On top of all this, there are inspections and certification all along the chain: GLP, GCP, GMP &c.
A not insignificant number of applications are rejected each year, or have very strict restrictions placed on their use.
Companies who come to the EMA to use their
scientific advice service have a far greater chance of getting approval. Sadly I can't find the figures right now for the % rejected with/without scientific advice.