Cystic Fibrosis Study: A Quality Review

Background

A pharmaceutical company had completed a Phase I/II Clinical Trial on the efficacy and safety of an investigational medicinal product, involving the use of the sites’ own spirometry equipment. One of the trials’ objectives was to assess treatment safety by measuring FEV1, FVC and FEF-25-75. Following completion of the Trial, the company wished to utilize Vitalograph’s expert Over-Reading Service to review spirometry test quality at key visits from printed site test reports to ensure that their spirometry study data was to the required quality standards.

The Solution & Benefits

• The customer requirements and expectations of the study were defined, and the optimal solution (scope/ processes/ quality standards) were agreed and documented. The data from 77 patients across 14 investigator sites were then provided to Vitalograph for review.
• A centralised data capture system was put into place to record the results of the Over-Reading.
• The Over-Reading was performed in a blind fashion to prevent any bias.
• 50% of the sessions underwent an additional QC review.
• An intra-variability check of 10% of the spirometry sessions being reviewed was performed by Over-Readers blindly reviewing each others’ work. This ensured all work was to the same standard.
• The environment testing conditions and calibration verification performance were reviewed as part of the Over-Reading service as well as the spirometry curves.
• All sessions were reviewed to 2005 ATS/ERS standards (which were the current version at the time of the trial).
• In addition to proving that the quality of the data was of an acceptable standard, the review also identified sites which did not perform as well as others and allowed for better site selection for future studies, and/or identified where additional site training was required.

Summary

Accurate and reliable data is crucial for ensuring a successful clinical trial. For this study Vitalograph setup a PFT capture system and process to efficiently carry out a quality review of the study data. Vitalograph is committed to helping our customers and developing new and flexible solutions to meet their clinical trial needs.

Use of sites’ own equipment is possible for both Spirometry and LV/DLco testing, but it is not a substantially lower cost for typical spirometry studies. Vitalograph’s expert Over-Readers will review spirometry in both centralized and non-centralized studies to ensure the quality of the study data, however, it is more powerful to review data as tests are performed within study (allowing feedback and on-going improvements to the quality of the data) rather than to retrospectively determine if the collected data is useable or not. 

Vitalograph can provide a more cost effective solution consisting of a COMPACT™ workstation with PFT capturing software, which is connected to the Vitalograph Web Portal allowing study specific configurations to be downloaded and potential for multiple Phase 1 studies to be performed on the same device.