Patient Profiles
An emerging area in the clinical trial field is patient profiles, which are individualized displays of patient data for regulatory/safety reviews. Elashoff Consulting can generate patient profiles from your existing clinical databases.
Overview
Our Patient Profiles have several different uses. First, they meet FDA regulatory requirements for patient profile submissions. Second, they can provide a compact overview of a patient's entire set of clinical data, useful for safety reviews and patient narratives. Finally, they are very useful for data QC, identifying questionable data that consistency checks can easily miss.
You do not need to reformat your existing clinical trial datasets, we can handle your existing data structures, naming conventions, and data formats.
We can provide the patient profiles in a variety of formats:
- Microsoft Word
- Web/HTML
Please contact us for more details. We also have a Patient Profiles website with more information on the software used to create the profiles.
Example #1
This profile is of a patient in a year-long study estimating the effects of a steroid on growth in pre pubertal children. It has 4 tables, one timeline and 1 graph. The timeline has both the days and dates of the study for reference. It incorporates all the adverse events (in red) and concomitant medication (in green) information. A more detailed list of the adverse events is underneath the timeline. We also can see the pattern of growth over time in a graph. This profile is useful for seeing at a glance the primary outcome variable (growth) along with how sick the patient was. (click on the image for a full size view)
Example #2
This example illustrates the information dense content of a patient profile. Adverse events are colored by severity, time on study drug is highlighted, and multiple labs are displayed. (click on the image for a full size view)
Example #3
In this example, outliers and missing data can be readily seen using patient profiles. This example also illustrates the power of coordinate displays of multiple endpoints and events. (click on the image for a full size view)
