Description
There are numerous related components that make up a clinical trial design. These range from the data to capture, the number of patients, randomisation and blinding through to matters such as whether the trial is looking to show equivalence or a difference between treatment groups.
This online module goes through the various components and details the various aspects and considerations of each one. The module explains among other matters the difference between parallel group and cross over trials, single, double and triple blinding, sample size considerations, and difference vs non-inferiority.
Who is it suitable for?
The module is designed for people currently working in clinical research in roles such as CTA, CRA, Regulatory Affairs, Investigators and Nurses, Project Managers, Data Managers and Medical Communication/Information positions.
The module is also suitable for individuals either new to the industry or wishing to join the industry as it provides an excellent insight into clinical trial design
Course Content
Background
 Confounding
Trial Objectives
Data & Endpoints
Fundamental Trial Designs
Parallel Group Trial
Cross Over Trial
Non-Comparative Trial
Randomisation
Stratification
Minimisation
Blinding & Masking
Open-Label Trial
Single Blind
Double Blind
Double Dummy
Triple Blind
Comparator
Different comparators
Selecting the comparator
Type of Comparison
Difference Comparison
Non-Inferiority
Equivalence
How Many Subjects?
Power and Sample Size
Populations
What Prior Knowledge is Needed?
It is useful to have an overview of the clinical trial process but this is not essential. This knowledge can be obtained by taking the module entitled Introduction to Clinical Research. |
