Clinical trials that collect respiratory endpoints are among the most expensive to conduct.1 In such a competitive environment where recruiting patients is increasingly difficult and costly, data from all patients need to be of the highest quality in order to meet regulatory standards and contribute to the success of the development program.
Read on to learn the three strategies sponsors can leverage to drive ~100% ATS/ERS-acceptable data or download the guide here.
However, a number of can obstacles get in the way of capturing ATS/ERS-acceptable data in respiratory clinical trials, including:
- Suboptimal patient coaching / maneuver performance
- Varied investigative site experience levels
- Inconsistent PFT data collection / review among investigative sites
All of these are even harder to overcome when sponsors rely on investigative sites to use their own, non-standardized equipment and don’t leverage central, expert overread for the review of this important data. In fact, in a recent study where approximately 3.3 million PFTs were conducted by sites not using standardized equipment, approximately 11% of the tests submitted by investigators had errors (Figure 1).2
In order to reduce risks and uncertainties about the safety and/or efficacy of their compounds, many sponsors adopt a centralized approach to spirometry and other PFT data collection, yielding high quality respiratory data that meet ATS/ERS standards.
3 Strategies for Improving Respiratory Data Quality
So how can you improve the data in your clinical trial? You can capture nearly 100% ATS/ERS- acceptable clinical trial data, every time, by centralizing respiratory data collection and adopting these three proven strategies:
- Drive quality at the site level
- Select optimal sites using historical performance data
- Achieve research-grade data with indication-focused education
- Avoid common (and uncommon) mistakes by leveraging project management
- Simplify global study logistics
- Offer dedicated site support
- Optimize data collection
- Integrate site equipment with intuitive, protocol-reinforcing software
- Demand quality in data management
- Centralize data reporting and analysis
- Optimize central overread
- Access holistic, real-time data in one portal
- Invest in enhanced business intelligence reporting beyond overread (Figure 2)
With centralized respiratory data collection, sponsors enable their investigative sites to reduce errors that contribute to overall variability and capture the highest quality respiratory data for any clinical trial. Standardized equipment ─ including software workflows that guide the patient through proper testing maneuvers ─ and customized site training on devices and indication-specific nuances minimize risks in respiratory data collection procedures and reduce uncertainties about the accuracy and acceptability of the collected data.
And, because centralized respiratory data collection includes overread by qualified respiratory specialists with real-time data availability, sponsors and CROs can quickly identify low performing sites and subject data outliers for review and intervention. As a result, they increase data quality, meet ATS/ERS standards, and achieve their clinical objectives faster.
Get more information on how these strategies can help you improve respiratory data quality in clinical trials – download the guide!