h2g2 The Hitchhiker's Guide to the Galaxy: Earth Edition

Entry: Good Clinical Practice: Organisation of a Trial - A5455712
Author: Varindweion - U1503746

The third part in the ICH-GCP series.

With all these scientists on h2g2, I'm surprised that no-one has commented on this at all!

I'm afraid the subject is beyond me - are you still around Varindweion?

Well, this is part of a suite of 3 Entries, and the comments have been made on the other two. The author was (recommended) to re-title them to s'thing more meaningful but, as I recall, he was a bit reluctant to do this.

Comments for this entry have been made on other forums? I'd suggest at least a few are made here, or the Scouts won't know whether this is ready for picking or not - especially if the other entries get picked and so are removed from PR.

Well, without returning to the other two threads, I think the author was going to reorganise all 3. So this isn't ready for picking at all.

Hey guys,

I've been busy lately, so haven't had much time to write the final part of the series.
About changing the titles..It's still not good enough?
Some suggestions might be in order, then.
I just want to keep it plain and simple. GCP is not a topic you read on a whim, but make a deliberate search for.
e.g. If someone comes in contact with it for the first time, they can always have a look around on H2G2 and maybe find my entries interesting enough.

This definitely doesn't deserve to be forgotten about. Anybody out there who can give this a read-through and pass some knowledgable comments about it?

Paully

Elvised. Back to entry?

Seconded.

Making a brief list, I think Mina is too. Still limited access, though

hey guys.
Is this still in review?
i'm still gathering material to write the last part of the series, by the way.

yes it's still in review.

Looking forward to reading the rest of the series. It's pretty topical right now

'It's pretty topical right now'

Yes, absolutely!

hmm, it's pretty topical...meaning?
Can you be a bit more specific, maybe I can make a few changes to improve it.

I think they're referring to the recent problems with a Phase 1 Clincal Research trial (see I did read the previous two entries! ) in the UK

see:

http://news.bbc.co.uk/1/hi/england/london/4807042.stm

While I'm here, I thought it was a generally good entry - I know next to nothing about clinical medical matters - one thing did puzzle me...

"Consistency is needed within the clinical database and between the clinical database and external data, e.g. data collected from the central laboratory about blood samples"

Could you elaborate a bit about consistancy? is it just making sure there are no errors in the data; or that all the blood results are given in the same units (eg mg/kg) or blood tests are conducted with the same methodology?

hmm, it's pretty topical...meaning?


Well, there's been 6 volunteers in intensive care in the UK after a clinical trial went wrong.
The volunteers had been paid £2000 /head to participate (s'thing the British public weren't aware could be done). The drug under test was TGN412, which is designed to treat rheumatoid arthtitis, leukaemia and MS. Apparently they suffered a severe auto-immune attack and it is thought that there could be permanent damage to their internal organs and long-term disruption to their immune systems.
Apparently, tests on monkeys in Germany showed an 'increase in their lymph nodes; and a study published in 2002 in Clin.Immunol warned that it adversely affected human cells. However, the manufacturers, TeGenero, of Germany claims that 'extensive preclinical tests showed no sign of any risk'.

Ah, I see.
Could stuff for part 4.

Thx.