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Re: jimmylee post# 17895

Monday, 08/25/2014 7:11:38 PM

Monday, August 25, 2014 7:11:38 PM

Post# of 732454
Relevant Abbreviations and Their Meanings:

PFS -- progression free survival
OS -- overall survival
DFS -- disease free survival
TTP -- time to progression
ORR -- objective response rate
CR -- complete response
PR -- partial response
HE -- Hospital Exemption
AA -- accelerated approval
MA -- marketing approval
SOC -- standard of care
IRB -- Institutional Review Board
IND -- Investigational new drug
NDA -- new drug application
BLA -- biologics license application
SSR -- sample size re-estimation
BSSR -- blinded sample size re-estimation
DMC -- data monitoring committee
DSMB -- data and safety monitoring board (basically same as DMC)
FDA -- Food and Drug Administration
EMA -- European Medicines Agency
PEI -- Paul Ehrlich Institute (Germany's FDA equivalent)
MHRA -- Medicines and Healthcare Products Regulatory Agency (UK)
Stat sig -- statistical significance
tx -- treatment or treatment group
pl -- placebo or placebo group
L -- DCVax-L
Direct -- DCVax-Direct
PDUFA -- prescription drug user fee act
ICT-107 -- IMUC's lead candidate for GBM
QOL -- quality of life
GBM -- glioblastoma multiform, i.e. stage IV brain cancer
rGBM -- recurrent GBM
ND-GBM -- newly diagnosed GBM
AL -- adaptive licensing


Those are probably the ones you'll see 99% of the time here, but by no means exhaustive. Here's more:

http://tracs.unc.edu/docs/regulatory/commonly_used_abbreviations_and_terms_in_clinical_trials.pdf
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