Course Details

One day classroom course with a mix of presentations and workshop sessions

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

By the end of this course participants will be able to:

• Discuss the different trial designs
• Summarise the considerations needed when designing a trial
• Implement a structure for effective protocol review

The course has is suitable for anyone involved in clinical trials and has previously been delivered for groups including the following roles:

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

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