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Clinical Trial Designs
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
Course Information for Clinical Trial Designs

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, 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
  • 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

Endpoints

  • Definition
  • Deciding on
  • Good, Bad and the Ugly

Randomisation

  • Block Size
  • Stratification & minimization
  • IVRS

Power and sample size

  • Entry criteria
  • Patient numbers
  • Drop out
  • Patient populations

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Previous Course Feedback
A Clinical Trial Designs Course was delivered for a Pharma Company. The Course had 24 participants. The feedback is shown below.
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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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