Blinded - neither the subject nor the treatment provider knows whether the subject has been assigned to the treatment group or the control group as an additional way to eliminate potential bias
CDA – confidential disclosure agreement
Continuous Variable - degree of improvement ranges along a continuum
Control Group - receives either a placebo or an active control, such as an existing SOC drug
CR – child resistant
CTM – clinical trial material
DMC – data monitoring committee
Double Blinded - blinds both the subject and the investigator
Dynamic Randomization - alters the chance nature of randomization by changing the probability that a given subject is assigned to a particular group via a random mechanism, based on the subject's characteristics and the characteristics of the subjects who have already been randomized
IVRS – interactive voice response system
IWRS – interactive web response system
MSA – master services agreement
MTD – maximum tolerated dose
NDA – new drug application
Non-Inferiority Margin – the clinically tolerable amount of difference
Open-Label - treatment assignment is known
Pharmacodynamics - the effect of the drug on the body, e.g. heart rate and respiration
Pharmacokinetics - the effect of the body on the drug including how it is absorbed, distributed, metabolized, and eliminated
Placebo - an inactive treatment
Randomization - assigns subjects to different treatment groups via a process of randomization such that neither the subjects nor the doctors know which group a subject will be assigned to in advance, thus eliminating conscious bias
SAP – statistical analysis plan
Single-Arm Pilot - administers a drug to a single group of subjects to see whether their condition improves
Single Blinded – blinds the subject by making all of the administered treatments appear the same
SOC - standard of care
Surrogate Endpoints - substitute variables that are used when a clinical endpoint is not convenient or feasible
Two-Arm Non-Inferiority – replaces the placebo arm of a placebo-controlled study with an active control, usually an SOC
Two-Arm Placebo Controlled - administers the experimental treatment of interest to one group and a placebo to the other
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