ERT held an educational webinar on centralized spirometry on July 14, 2011, that included guest speaker Jim Sowash, Director of Respiratory OverRead. Jim has been with ERT for over 10 years and in his current role, he oversees the review of pulmonary function data collected for COPD, Asthma and IPF clinical trials. His team, which consists of respiratory therapists, master’s degreed exercise physiologists and nurses, are responsible for reviewing greater than 20,000 spirometry measurements per week. Professional experiences include co-authoring over 15 professional posters, presentations, abstracts, and articles in organizations such as the American College of Sports Medicine, the American College of Chest Physicians and the American Thoracic Society.
At the start of the webinar, Jim surveyed the audience to gauge how the attendees view
centralizing spirometry data in relation to the cost of their clinical trial. The audience was asked specifically”Does a centralized approach allow for a sponsor to collect higher quality data with a lower overall cost?” The responses were as follows:
64.30% of attendees agreed that a centralized approach results in higher quality at lower costs, while 18.60% of attendees believed a centralized approach yields higher quality but at higher costs, and 17.10% of attendees didn’t know.
As the webinar continued, Jim discussed why we are so concerned with Respiratory
diseases and the affects they have on society. Statistics of compounds currently undergoing research in clinical trials for Asthma and COPD were also discussed.
Throughout the webinar, several pressing questions were answered, such as:
- What are the issues impacting the variability of spirometry values causing
unacceptable data collection?
- Which measurements need to be controlled in order to best see a treatment effect?
- What is centralized spirometry?
- Why should you centralize spirometry data?
Jim proceeded to explain the differences between standardized spirometry, centralized spirometry, and the various combinations of the two, including: non standardized and non centralized, standardized with centralized review providing feedback on data quality, and standardized with centralized review providing feedback on data quality and optimization of data (Best Test Review). The pros and cons of each approach, as well as the processes and levels of quality control performed were also clarified.
In closing, the goals of a centralized review process, the effects that optimized data can have on your clinical study, and the advantages of centralized Respiratory OverRead were reviewed. The chart below represents a high level overview of the benefits centralization can have on your spirometry data.
As shown, the further you centralize and optimize your spirometry data throughout the study, the greater the percentage of acceptable data is collected, resulting in fewer patients, increased statistical power and reduced costs.
Finally, Jim asked the audience the same poll question that began the webinar, only this
time the answers were slightly different. After an hour of discussion, the proportion of viewers who thought that a centralized approach allows for a sponsor to collect higher quality data with a lower overall cost had significantly increased by 17.7% to 82%.
If you would like to view this webinar for the detailed overview of spirometry and the
process of centralization, please click the link below. You may also request a copy of the presentation slides by emailing firstname.lastname@example.org.
As always, comments, questions and feedback are welcome below or via email. Thank you for being a part of the ERT global community!