Course Details

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

The reading or development of medical literature is a major part of many roles in the pharmaceutical industry. By the end of this course participants should be able to:

• understand how to interpret results
• identify limitations of results caused by trial design and conduct 
• summarise and use the seemingly complex statistical results in papers and reports

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

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