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How to Design a Successful Clinical Trial
Categories:
Pharmaceutical
Understand the critical and central role that Clinical Trial Design plays in the success of a clinical trial.
What Is The Course About?
This course reveals the importance of clinical trial design for the success of the trial, including the key role of statistical design in achieving the dual aims of treating patients and gaining additional information to increase understanding of the disease.
The objectives of this course are:
- To understand the key elements of clinical trial design and how they interact
- To understand how protocol design, statistical design and CRF design combine to provide the
platform for the clinical trial
- To understand the importance of a clearly defined protocol and a well-designed CRF that enables data to be captured easily, accurately and clearly
- To understand how statistical design influences the design of the trial and how advanced statistical computing techniques can be used to extract valuable information from trial data
The full fee for this course is £590 +vat and includes full course materials, lunch and refreshments.
Course Programme:
Welcome, Introductions and Objectives for the Course
The Importance of Good Clinical Trial Design
- Why do we need good clinical trial design?
- How to plan good clinical trial design
The Ideal Team To Ensure Good Clinical Trial Design
- What elements involve design decisions to be made?
- Who should be involved/consulted during making them?
- The essential team roles
Defining The Key Elements That Lead To Good Protocol Design (Part 1)
- Aims & Objectives
- Choice of Design
Defining The Key Elements That Lead To Good Protocol Design (Part 2)
- Endpoints
- Choice of Comparator
The Role and Design of the CRF
- Who uses the CRF?
- Aspects of Design
Integrating the Study Documents
- Which documents need to be integrated?
- Where are they integrated?
Hints & Tips To Avoid Common Mistakes
Course Dates
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The course either has new dates in data loading, or is only run as a dedicated or In Company course.
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Key Details
Provided by:
Rostrum Training Solutions Limited
Duration
1 day
£590
per delegate