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 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
How to determine the objectives and hypotheses
Trial design considerations
Understanding the trial design
Assessing bias and confounding
Sample size and expectations
What was done vs What was intended
What is missing?
Baseline Comparisons& Population Flow
Group balance and prognostic factors
Different analysis populations (FAS, ITT, PP, Safety)
Dropout, withdrawals and bias
Interpreting Trial Results
What will be a good result?
p-values and confidence intervals
Non-inferiority and Difference
Parametric and Non-Parametric Tests
Identifying the most relevant parts of the results
Odds ratios,hazard ratios, LS Means,
Relative and absolute risks, difference in percentages
Using and interpreting graphs
Reviewing graphical displays of data