PharmaSchool: Clinical Trial Designs

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: CTM003

Enquire about course | Previous Feedback

Duration: 1 Day

Description

Clinical trials vary widely in design. It is important to understand the design of a trial to be able to effectively review protocols, review papers, complete ethics committee submissions, write patient information sheets as well as to design clinical trials. This course provides an essential foundation in clinical trial design and the knowledge needed to be able to design, review and summarise protocols

This course will give delegates:

the different trial designs
the considerations needed when designing a trial
a structure for effective protocol review
This course is suitable for anyone who is involved in clinical trials.

Who is the course suitable for?

The course has previously been delivered for groups including the following roles:

CRAs
CTAs
Study Nurses
Investigators
Data Managers
Project Managers
Clinical Trial Coordinators
MSLs
Medical Advisers


Example Content

Trial designs

Parallel
Cross-over
Non-comparative
Challenges and limitations
Bias

Types of trial

Objectives
Difference/superiority trials
Equivalence
Non-inferiority
Different Phases and related designs

Endpoints and Objectives

Definition
Surrogate and composite
Primary - multiple vs co-primary
Secondary and exploratory

Minimising Bias: Randomisation and Blinding

Block Size
Stratification & minimization
IVRS
Open, single and double blind
Considerations for blinding

Specific Designs (can be tailored to specific phases, e.g. phase IV trials)

Specific types of designs relating to selected phase of trial

Additional Considerations

Interim analyses
Stopping rules and futility
Event driven trials

Power and sample size

Entry criteria
Patient numbers
Drop out
Patient populations

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: Clinical Trial Designs
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.
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