Professional Documents
Culture Documents
RCT Report - Chua
RCT Report - Chua
CLINICAL TRIALS
Erika Chua
Medical Oncology Fellow
ELEMENTS OF AN
RCT
Effectiveness Randomization
New Intervention Examine cause-effect
VS relationships
Control
Randomized
Clinical Trials
Concerns regarding
Prospective data collection
duration of follow-up
Inefficiency of detection
Randomization
of rare or delated outcomes
Types of Randomized Clinical Trials
Parallel RCT
Sampling Size
The only way to simultaneously DECREASE
both Type I and Type II Errors are:
1. Increase the Sample Size
2. Increase the Size of the Minimum Effect that the Trial will
Detect
Sample Size Estimation
One-sided Two-sided
Directional Non-directional
Region of rejection either left or right Region of rejection both left and
right
RCT CONDUCTION
Conducting an RCT
Randomization Allocation
■ Treatment and
comparison groups ■ Random assignment
should be to either treatment or
comparable in all comparison groups
aspects except the one
being studied ■ Stratification: use
of factors known to
■ Ensure that the influence the disease
distribution of these being studied to
factors is based on structure allocation
chance and not on
factors that may lead
to bias
Benefits of Randomization