PharmaSchool: Interpreting Trial Results in Medical Literature

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: CTM006

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Duration: 1 Day

Description

The reading or development of medical literature is a major part of many roles in the pharmaceutical industry. In order to be able to fully effective in such a role it is essential to be able to understand how to interpret the results, how to identify limitations of the results caused by trial design and conduct as well as being able to summarise and use the seemingly complex statistical results in the papers and reports.

Who is it suitable for?

The course is designed for groups of delegates who regular have to create, read or summarise medical literature. The course has previously been tailored to include a review of and examples from medical literature provided by the customer. This has previously included:

Medical Advisors
Investigators
Medical Information Personnel
Medical Communication and Medical Writers
Sales and Marketing Teams


Content

Overview of components of medical literature

Order of review

Checklists and Requirements for Publication
Overview of checklist
Submission Requirements
CONSORT

Objectives

How to determine the objectives and hypotheses

Trial design considerations

Understanding the trial design
Assessing bias and confounding
Sample size and expectations
Endpoints
What was done vs What was intended
What is missing?

Baseline Comparisons& Population Flow

Group balance and prognostic factors
Covariates
Different analysis populations (FAS, ITT, PP, Safety)
Dropout, withdrawals and bias

Interpreting Trial Results

What will be a good result?
Statistical Significance
p-values and confidence intervals
Non-inferiority and Difference
Parametric and Non-Parametric Tests
Identifying the most relevant parts of the results

Summary values:

Odds ratios,hazard ratios, LS Means,
Relative and absolute risks, difference in percentages

Using and interpreting graphs

Presenting data
Reviewing graphical displays of data

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: Interpreting Trial Results in Medical Literature
Customer: Medical Communications Company
Number of Participants: 17
How well fulfilled were your personal objectives for this course?
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How satisfied were you with the Trainer's Style & Knowledge?
Great Deal (94%)
Fair amount (6%)
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Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.9
Participant Feedback :
Going to make my job a whole lot easier. Many thanks.
Brilliant, we need to put the rest of our company on this course.
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