PharmaSchool: Sample Sizing for Clinical Researchers

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: CTM008

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Duration: 1 Day

Designed for: Anyone involved in the design of clinical trials or involved in writing clinical trial reports or manuscripts, including:

CRAs
Project Managers
Medical Advisers
Investigators
Medical Writers
Project Accountants


The Course is ideal for groups who have to determine their own clinical trial sample sizes without input from Statisticians as well as groups who need to understand the components to more effectively work with statisticians to determine sample size.

Description: This Course is designed to equip the participant with the essential knowledge as to the requirements of sample sizing which include the key components of power, significance and assumptions. This course is not designed to be statistical and will include no mathematics or formulae, instead this gives a practical insight into how sample sizing is done and the most effective approaches to it.

The Course is a blend of theory and practical hands-on experience using sample sizing software to compute real sample sizes and explore the various assumptions.

Content:

The Key Components

Power
Significance and relationship to p-value
Assumptions
Standard deviation


Framework for Sample Sizing
Obtaining estimates and assumptions
Deciding on power
Sample sizing process


Sample Sizing Continuous Data
Assumptions & Methods
Practical Examples


Sample Sizing Binary Data
Assumptions & Methods
Practical Examples


Sample Sizing Time to Event Data
Event Driven Trials (time to death, progression etc)
Additional assumptions
Event rates leading to sample size
Practical Examples


This Course has been added for 2013 due to feedback from our hugely successful courses 'Statistics for Non-Statisticians' and 'Clinical Trial Designs'. Feedback has asked for a dedicated course on Sample Sizing for Non-Statisticians.

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

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Previous Course Feedback: Sample Sizing for Clinical Researchers
Customer: European Pharma Company
Number of Participants: 20
How well fulfilled were your personal objectives for this course?
Fully (75%)
Well (25%)
Not Very Well (0%)
Not At All (0%)
How satisfied were you with the Trainer's Style & Knowledge?
Great Deal (100%)
Fair amount (0%)
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How much have you learned that you will be able to apply to your job?
Great Deal (80%)
Fair amount (20%)
Not Much (0%)
None At All (0%)
Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.6
Participant Feedback :
I have sat through a number of presentations on medical statistics in my career, and I can honestly say this was the best.
You managed to make the subject understandable and accessible, and the feedback from all the delegates was overwhelmingly positive.
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