Vanderbilt Department of Neurology

Survival Guide to Clinical Research (2014) - Dr. Fang

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
Q. FDA (510k) guidance

II. Statistics

A. Parametric
B. Non-parametric
C. Normal distribution
D. Odds ratio (Hazard ratio)
E. Hosmer-Lemeshow goodness of fit test for Survey data
F. Jaccard Index - This is simply a ratio of the intersecting portion of two sets vs. the total of the sets
G. Correlation vs. Regression
H. Cronbach Alpha - A method of measuring internal consistency within a confined population. Basically, larger sample sizes and lower variance result in higher alpha. High alpha translates to greater internal consistency. Think of this as a coefficient of consistency within a sample.
I. Bootstrapping - A method of assessing sampling error or bias by resampling from the original sample. This technique can be used multiple times. For bootstrapping to be statistically valid, the samples must be independent.

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

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