Background
A customer conducted a phase II Clinical trial investigating the efficacy and safety of an investigational medicinal product for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The customer wished to use Vitalograph’s standardized equipment and centralized services to support their study.
The Solution & Benefits
The scope of the study was reviewed and the following solutions were provided:
- Standardized equipment and centralized services to support Spirometry, PFT and DLco data capture.
- Standardized equipment and centralized services to support ECG data collection.
- Over-Read services for spirometry and DLco to ensure the quality of data, based on ATS/ERS standards at the time of the study and in accordance with the protocol requirements, were obtained.
- Over-Read services for ECG data by trained cardiac experts and Board-Certified cardiologists (when required).
- User friendly software tailored to the specifics of the protocol to ensure the study was protocol driven and randomization, inclusion/exclusion and study alerts were automatically calculated and reported to site users.
- Training was provided at a centralized investigator meeting and following completion of the training session Vitalograph monitored site users’ proficiency for certification and retraining requirements.
- Dedicated Project Manager and team allocated to the study to specify the study requirements and ensure the smooth running and quality of the study, whilst ensuring it was within budget.
- Data Management services for central collection of the study data, data cleaning, and secure data transfer at the agreed frequency.
- Reporting Services for generic and custom reports that allowed sites, CRAs, and sponsors to review the progression of the study and to be notified of eligibility or study alerts so that informed decisions could be made in a timely manner.
- Site Support services to assist sites with any technical difficulties they experienced with the Vitalograph system.
Summary
Pulmonary function testing is a useful tool in assessing IPF patient’s lung function impairment as forced vital capacity and total lung capacity decline as fibrosis progresses. The single breath diffusing capacity of the lung for carbon monoxide, corrected for hemoglobin, is almost always reduced even in early disease.
By providing PFT, spirometry, DLco and ECG services, Vitalograph were able to assist the sponsor in capturing good quality data for their clinical trial’s exploratory outcome measures.
