1. Event-Level Narrative
Efficient Safety Assessment in Clinical Trials Using the Computer-Generated AE Narratives of JMP Clinical
Richard C. Zink & Drew Foglia
JMP Life Sciences, SAS Institute
Background
Challenges
Event-Level Narrative
ICH Guideline E3 on the content of clinical study reports (CSRs) recommends that sponsors provide written narratives describing each death, serious adverse event (SAE), and other significant AE of special interest to the disease under investigation. Narratives may shed light on factors associated with severe events, or describe effective means for managing patients for appropriate recovery. We describe how AE narratives can be generated directly from study data sets using JMP Clinical
Medical writer has to review disparate data sources
Not composed until patients complete study. Rate-limiting factor in completing the CSR.
Changes to database may cause incorrect reporting; narrative text updated manually.
The volume of events for severe diseases consume a great deal of resources
Example
Details
Nicardipine trial (Haley et al., 1993) has 683 SAEs for 310 patients
Sample narrative, which includes laboratory findings, has 409 words
At 70 words-per-minute, it would take 5.8 minutes to write
To write all narratives:
3991 minutes
67 hours
1.675 full-time equivalent
What factors led to the event?
What medications, evaluations or tests were associated with the event?
Did the patient recover?
What factors led to recovery?
Was treatment related to the event?
Did the patient complete the trial, or did the SAE cause the patient to discontinue the trial or interrupt study therapies?

2. Returning to the Example
Efficient Safety Assessment in Clinical Trials Using the Computer-Generated AE Narratives of JMP Clinical
Richard C. Zink & Drew Foglia
JMP Life Sciences, SAS Institute
Time Estimate Ignores
JMP Clinical
Narrative Dialog
Time estimate ignores
Comparing data sources
Performing mental calculations
Quality control
Thinking and reflection
Trips for coffee
Bathroom breaks
Narratives are extremely resource intensive!
Dialogs to select narrative options
SAS code and Velocity™ (project of the Apache® Software Foundation) templates to build the narrative text
Returning to the Example
683 SAE narratives were generated in less than one minute
Huge time savings compared to FTE!
CDISC!
Narrative Dialog
Subject-level analysis data set (ADSL)
Adverse events (AE)
Concomitant medications (CM)
Demographics (DM)
Disposition (DS)
Study medication exposure (EX)
Healthcare encounters (HO)
Medical history (MH)
Up to three findings domains, for example
ECG test results (EG)
Laboratory test results (LB)
Vital signs (VS)
Conclusions
JMP Clinical AE Narratives
Accelerates the writing process
Improves quality control
Allows for additional nuanced detail to be added by the medical writer, including JMP figures
Table of contents, watermarks, images
Focus on the science
Guide appropriate management of patients

3. Subject-Level Narrative Event-Level Narrative with Tables
Efficient Safety Assessment in Clinical Trials Using the Computer-Generated AE Narratives of JMP Clinical
Richard C. Zink & Drew Foglia
JMP Life Sciences, SAS Institute
Subject-Level Narrative
Translated Narrative
Event-Level Narrative with Tables