Validation of a patient-reported e-diary to support a primary trial endpoint

The challenge

Our client planned to use a patient-completed electronic diary in a phase 3 trial of a product for a sleep disorder. However, the electronic version of the diary had not been validated according to FDA standards. 

Our solution

We designed a bespoke study to evaluate the content validity, usability and psychometric properties of the electronic diary according to FDA standards, focused on aspects supporting the primary and key secondary endpoints.

Our approach

We conducted interviews with patients to evaluate the content validity and usability of the e-diary. We also designed a collaborative study to develop the study documentation, which included training of interviewers at the sleep clinic in the US conducting the trial, development of the statistical analysis plan for psychometric testing, and analysis of the data according to regulatory standards. 

The outcome

The evidence required to support validation of the e-diary was developed rapidly and to a high standard, for incorporation into the clinical trial.