Department of Neurology

Survival Guide to Clinical Research

I. Vocabulary

A. Phase
B. Prospective
C. Retrospective
D. Case series
E. Inclusion / Exclusion Criteria
F. Adverse Event
G. Adverse Drug Reaction
H. Humanitarian Device Exemption
I. Investigational New Drug
J. Intention-to-Treat Analysis
K. Meta-analysis
L. New Drug Application
M. Primary outcome measure
N. Dose-response curve
O. Non-inferiority study
P. Equipoise

II. Statistics

A. Parametric
B. Non-parametric
C. Normal distribution
D. Odds ratio (Hazard ratio)
E. Homer-Lemeshow goodness of fit test for Survey data

F. Correlation vs. Regression

III. Pitfalls

A. Unqualified investigators
B. Bias
C. Poor study design

1. Irrelevant question
2. Too restrictive
3. Unrealistic expectations
4. Lack of adequate controls

D. Failure to account for natural history of the disease
E. Failure to account for placebo effects
F. Failure to account for comorbidities

1. Inadequate sample
2. Inadequate blinding (or masking), where applicable
3. Lack of independence between variables (eg. studying the effect of age on mortality)

G. Unexpected changes in disease status