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Subgroup Analysis

Level:
Foundation
Area:
Professional Techniques
Code:
PTF23
Duration:
03:00:00
Workshop profile:
This workshop is targeted at medical writers who are aware of clinical studies, protocols, and clinical study reports.
Objective:
The objective of this workshop is to understand the concept of subgroup analysis in clinical studies, and how to appropriately apply it to protocol and clinical study report writing. This workshop will also familiarise participants with the current European Medicines Agency (EMA) regulations on subgroups.
Content:
This workshop will cover the importance of subgroup analysis, based on the current EMA regulations, and the associated limitations. This workshop will illustrate the implications of inappropriate emphasis on subgroup findings, the implications of false-positives and false-negatives when making claims on the efficacy and safety of drugs, and discuss the considerations for protocol and clinical study report writing.