Overview

This Solution Provider Webinar is brought to you by DIA in cooperation with

With the increase in size and complexity of the data associated with clinical studies, in particular oncology studies, using data standards, visualization standards, and sophisticated algorithms are necessary to provide medical writers, clinical data scientists, and medical officers with the information needed to perform their tasks in an efficient manner. Utilizing interactive summary graphics to drill down on populations of interest allows clinicians to focus on patients with the greatest efficacy response or safety issues. Upon finding these subjects of interest, medical writers and medical officers can explore their details by generating Adverse Event Narratives or Patient Profiles to understand their impact on the overall results of the study.

Continuing Education Credits are not available for this event.

Featured topics

Semi Automated Adverse Event Narratives
- Demonstration of narratives for the Clinical Study Report including for subjects experiencing Serious Adverse Events, Discontinuations, as well as those of Special Interest

Tumor Lesion Response Analysis
- Gain an understanding how regulatory agencies and sponsors interpret results using interactive summary visualization techniques including: Progression Free Survival, Swimmer Plots, Waterfall Plots, and Spider Plots

Who should attend?

Professionals who work in the area of:

Medical Writers
Clinical Data Scientists
Medical/Data Monitors
Medical Reviewers
Data Managers

Learning objectives

At the conclusion of this webinar, participants should be able to:

Identify how to organize and select relevant supporting information such as concomitant medications, laboratory data, and other associated events that feed into adverse event narratives
Understand Progression Free Survival curves and hazard ratio forest plots for patient subgroups
Interpret a qualitative tumor response evaluation using a graphical technique called Swimmer Plots
Evaluate the patients’ overall quantitative “best” response in tumor shrinkage using a graphical technique called Waterfall Plots
Recognize patient trends in tumor results and new lesion occurrence across study visits/time using a graphical technique called Spider Plots

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