Rare Disease Study: A Study Rescue in Pandemic

Background

A Phase 3 clinical trial was started pre-pandemic, with Vitalograph providing equipment and services.

This was a long study including subjects with a rare disease that required long term monitoring and follow-up. The COVID-19 pandemic put the trial at risk of being cancelled or compromised as clinic visits would expose the very vulnerable subjects to infection.

The Solution & Benefits

Vitalograph’s current clinical solutions were easily adapted to mitigate against potential site closures.

• A home monitoring system was created by adapting the Vitalograph In2itive^TM handheld e-Diary so that it captured full flow volume curves, enabling FVC, FEV1, FEV1/FVC and FEF25-75 measurements to be captured without clinic visits.
• The subjects were able to perform their clinic visits at home with coaching from the site technician over the phone.
• The In2itive e-Diary provided quality alerts after each maneuvre in accordance with the ATS/ERS spirometry guidelines.
• Session alerts were provided regarding repeatability and acceptability of the test session.
• Over-Reading of each session ensured the quality of the study spirometry data was not compromised.
• All data was available to the site, CRA and sponsor, in near real time, via the  Vitalograph Web Portal, which is a centralised system for the collection, management and review of study data.
• As the system is patient facing, the devices are user friendly with a high resolution colour touchscreen display, and are robust with an accurate Fleisch Pneumotachograph flowhead.

Summary

Vitalograph are committed to helping our customers in all aspects of their trial and especially when unforeseen circumstances arise. 

As we manufacture our own devices and have in-house software developers and engineers, we were able to create a home solution so that this clinical trial could continue should clinic access be limited, where subjects experienced travel difficulty or where clinic visits needed to be minimized. This helped to protect the safety of the subjects in the trial, support sponsors in reducing in-clinic visits, and ensure the highest quality of data was obtained.