4 ms·

Those are never, ever stored with the pharma companies. If FDA finds out they are you can close shop.

by stef25 6y ago

deleted 6y ago
[deleted]
pas 6y ago
Where they are stored? At the investigator of the trial?
- stef25 6y ago
  Yeah, wherever they are usually stored. As I said in another comment - the only data the pharma company gets to "take home" is anonymized (partially, ie. a number instead of a name) and blinded (you don't know if they received drug or placebo) The company must reconcile the patient data with the trial data (on premise), in a scenario like: "liver enzymes abnormal after administration of vaccine, is there anything in the patient data that could clarify that (apart from the vaccine itself)". Someone has to painstakingly go through all that data. Source: this was my job
  - labawi 6y ago
    After the study is concluded, won't they get the non-blinded (still anonymous) version? During efficacy/side-effect analysis you should definitely use only blinded data. After confirmatory statistical analysis, it seems reasonable to go over the data in an exploratory pass to possibly discover/hypothesize why/when/how the medicine works/fails/interacts. Or do they just get the aggregate report?
chokeartist 6y ago
Interesting. I never thought there was a "hard firewall" between the pharma and the end-users in the clinical trial. Now that I think about it - yeah that's probably a really good thing.
vikramkr 6y ago
It looks like this was an attack on the EMA, so that data could have been present there
jiveturkey 6y ago
if by close shop you mean, pay a token fine as the cost of doing business and move on, the yeah. if it were useful to big pharma to have that info, they’d have it.
- stef25 6y ago
  It's not useful to them. And even if it was, they'd be breaking half a dozen rules at the risk of getting the whole study trashed and billions lost, for almost no benefit. Getting a study invalidated is the nightmare scenario of every pharma company. And it's not just the FDA or EMEA but also scientific journals that go through this stuff.

Those are never, ever stored with the pharma companies. If FDA finds out they are you can close shop.

by stef25 6y ago

Those are never, ever stored with the pharma companies. If FDA finds out they are you can close shop.

deleted 6y ago

[deleted]

pas 6y ago

Where they are stored? At the investigator of the trial?

stef25 6y ago
Yeah, wherever they are usually stored. As I said in another comment - the only data the pharma company gets to "take home" is anonymized (partially, ie. a number instead of a name) and blinded (you don't know if they received drug or placebo) The company must reconcile the patient data with the trial data (on premise), in a scenario like: "liver enzymes abnormal after administration of vaccine, is there anything in the patient data that could clarify that (apart from the vaccine itself)". Someone has to painstakingly go through all that data. Source: this was my job
- labawi 6y ago
  After the study is concluded, won't they get the non-blinded (still anonymous) version? During efficacy/side-effect analysis you should definitely use only blinded data. After confirmatory statistical analysis, it seems reasonable to go over the data in an exploratory pass to possibly discover/hypothesize why/when/how the medicine works/fails/interacts. Or do they just get the aggregate report?

chokeartist 6y ago

Interesting. I never thought there was a "hard firewall" between the pharma and the end-users in the clinical trial. Now that I think about it - yeah that's probably a really good thing.

vikramkr 6y ago

It looks like this was an attack on the EMA, so that data could have been present there

jiveturkey 6y ago

if by close shop you mean, pay a token fine as the cost of doing business and move on, the yeah. if it were useful to big pharma to have that info, they’d have it.

stef25 6y ago
It's not useful to them. And even if it was, they'd be breaking half a dozen rules at the risk of getting the whole study trashed and billions lost, for almost no benefit. Getting a study invalidated is the nightmare scenario of every pharma company. And it's not just the FDA or EMEA but also scientific journals that go through this stuff.