PharmaSchool: Statistical Considerations for Trial Design

Please contact Jo Burmester at to find out more about in-house courses and discuss your specific needs.

Course Code: CTM009

Enquire about course | Previous Feedback

Duration: 1 Day


The Course is designed to equip the delegate with an understanding of the key components of Clinical Trial Design. This also includes an explanation of the critical statistical aspects of trial design while assuming no prior knowledge.

Designed For: Anyone involved in the design of clinical trials including

Project Managers
Medical Advisers

Outline Agenda:

Trial Design Considerations

Cross Over
Different Designs, incl Two Stage, Factorial, Group Sequential


Multiple/Alternative and Co-primary
Key secondary

Superiority or Non-Inferiority

Success and Failure
Selecting Margins
Switching between Non-Inferiority and Superiority

Sample Size

Entry criteria
Improving interactions with the statistician
How it is done

Success Criteria

Statistical Significance
non-inferiority criteria

Interim Analysis

Statistical implications for interim analyses
Adjustments for interim analyses
Stopping rules, boundaries, efficacy, safety and futility

Multiple Comparisons and Alpha Spending

What is alpha?
Why do we need to control alpha
What is alpha spending

Bayesian vs Frequentist

What is the difference between Bayesian Trials and other trials?
Bayes Theorem and the Bayesian Framework

Choice of Analysis Population

Which population is the correct one
How do we select a population
Intention to Treat, Modified ITT , Per protocol

Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here

Show all Customised In-house Courses

Previous Course Feedback: Statistical Considerations for Trial Design
Customer: Pharma Company
Number of Participants: 24
How well fulfilled were your personal objectives for this course?
Fully (96%)
Well (4%)
Not Very Well (0%)
Not At All (0%)
How satisfied were you with the Trainer's Style & Knowledge?
Great Deal (92%)
Fair amount (8%)
Not Much (0%)
None At All (0%)
How much have you learned that you will be able to apply to your job?
Great Deal (83%)
Fair amount (17%)
Not Much (0%)
None At All (0%)
Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.6
Participant Feedback :
Great! I think it assumed we know about trial design and this showed us just what we did not.
Interesting and useful. Puts a great deal of topics into perspective.
Enquire about course | Top of Page
PharmaSchool Course Enquiry Form:
Your Name:
Your Company:
Your Enquiry
Approx Number of People
Proposed Location
Preferred Contact Method
Top of Page | Previous Feedback
PharmaSchool Logins

Learning Management Centre
CPMC Login
My GCP Zone Login
Retrieve Online Order

Free GCP & Regulatory Updates

GCP Challenges
from PharmaSchool

Over the last 12 years PharmaSchool has provided a free weekly GCP & Clinical Research related challenge. With nearly 3 quarters of a million attempts at these Challenges they are used across the World to test, learn and document knowledge.

Clinical Research Random Questions
GCP by Numbers
EU Medical Devices Regulation
Risk Based Monitoring

Click to see the full range of Challenges>

News & Corporate Information