How to Improve Respiratory Data Quality in Non-Respiratory Clinical Trials

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Clinical trials that measure pulmonary lung function ─ whether for respiratory or non-respiratory diseases ─ are among the most expensive to conduct.1 In such a competitive environment, it’s critical that trial sponsors capture the highest quality data from all patients in order to drive success of the study and the overall development program.

But, the process of evaluating lung function via standard spirometry tests is wrought with challenges, causing the respiratory data derived from these tests to be inherently variable. In fact, the American Thoracic Society (ATS) / European Respiratory Society (ERS) state, “The largest source of subject variability within a respiratory clinical trial is the improper performance of a pulmonary test.”

Variability in clinical trial respiratory data can impact go/no-go decisions

High data variability can result in the need for pivotal programs to be repeated, and at earlier development phases, can impact go/no-go development decisions. Trial sponsors can avoid these consequences by taking steps to address the challenges of pulmonary function testing (PFT) – whether they are developing treatments for respiratory or non-respiratory diseases.

View the webinar, ‘Lung Safety & Disease Progression in Non-respiratory Trials’ or read on for more information.

Lung Function Testing in Non-Respiratory Trials

When you think of conducting PFT, you’re probably thinking about a trial in respiratory disease, like asthma or COPD, right?  But there are several scenarios in which sponsors developing non-respiratory treatments need to conduct PFT in order to evaluate their compound’s effect on lung safety and/or disease progression.  Let’s review a few here:

  • Delivery route for inhaled drugs: The lung can serve as the entry organ for drugs treating non-pulmonary conditions, e.g., delivering insulin through the lung in inhaled formulations of diabetes other systemic disease treatments, or as an alternate route for administering vaccinations.
  • Systemic toxicity of drugs / interventions: Because the lung is one of the few organs that 100% of circulating blood volume passes through, it can be exposed to systemic drug toxicity. For example, the lung can be exposed to radiation simply by means of anatomy.
  • Disease progression via the lung: There are a number of non-respiratory diseases in which the lung is a very important target organ to track disease progression. Included in this category are Oncology, Amyotrophic Lateral Sclerosis (ALS), and Multiple Sclerosis (MS) treatments, among others.

Improve Respiratory Data Quality through Centralized Data Collection

There are many obstacles that get in the way of capturing high quality respiratory data in clinical trials, including:

  • Protocol complexity
  • Suboptimal patient coaching and 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 over read 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

11% of respiratory tests submitted by clinical trial investigators had errors 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 PFTs to yield high quality respiratory data that meet ATS/ERS standards.

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 over read by qualified respiratory specialists with real-time data availability, sponsors and CROs can quickly identify low performing sites and subject data outliers so they can intervene to increase data quality and meet their clinical objectives faster.

Conclusion

Whether you’re conducting PFT in a clinical trial to evaluate the efficacy of a respiratory compound, or to determine a non-respiratory compound’s effect on lung safety or disease progression, centralizing data collection and analysis processes ensures the highest quality data to drive the success of your study and overall development program.

For more information on how to improve respiratory data quality in clinical trials, read ‘Three Respiratory Strategies that won’t Leave You Breathless.’

References

  1. https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development
  2. Data on file, ERT
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