The Value of Standardized Quality and Performance Metrics in Clinical Trials

It’s not just tumor measurements that matter! Quality and Performance Measurements are critical too.

Imaging biomarker metrics are not the only measurements that matter in oncology imaging trials. Quality and performance metrics are just as important and necessary for running a successful clinical trial with image analysis metrics as the endpoints.

Biopharma organizations optimize clinical trials by operationalizing both quality and performance metrics.  The need for the industry to adopt vetted, standardized operational time, cost and quality metrics for tracking and predicting performance is clear. Metrics should have standard definitions of key terms and study milestones, along with performance targets to ensure that the metrics are measuring the right factors in the right way. [ii]  Driven by competitive and regulatory pressures, and the idea that “you can’t improve what you don’t measure,” the goals of standardized quality and performance metrics are to plan and predict performance by identifying known risks.  The purpose is to be proactive on understanding the level of risk so you can measure and monitor that risk over the course of the trial. [ii]

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Quality Measurements

Quality metrics are all metrics related to the quality of medical imaging data produced during a clinical trial. Clinical trial sites must comply with the imaging protocol in a high-quality manner so that it delivers valid and reproducible results. This means having an appropriately trained site investigator and staff, using imaging devices that are properly calibrated and performing up to specifications, following standardized methods for image acquisition (device parameters, slice thickness, patient positioning, appropriate anatomical coverage), performing high-quality image analysis (proper training of radiologists, patient de-identification, use of high-quality software to minimize variability), and strictly adhering to the protocol itself. [i]

Within the lifecycle of an imaging trial, trial performance can be tracked using four types of metrics:

• Cycle times,
• Timeliness,
• Quality,
• and Efficiency/Cost.

Quality metrics can be further measured as image quality, image queries sent to sites, missing imaging visits, and adherence to the acquisition protocol.

Performance Measurements

All performance metrics are measured around the data, which indicate overall trial quality. Performance metrics are established by the drug development industry in order to measure and standardize various components of clinical development times and clinical trial deliverables. By using metrics, sponsors and their outsourcing partners can manage and track quality and resources—e.g., people, time, and money—to gauge the productivity and efficiency of each over the course of a clinical trial. This allows the clinical trial sponsors to reduce drug development times and costs, and dramatically increase productivity while maintaining quality.

Standardized performance metrics improve research & development strategies and performance both within a company and across the entire drug development industry. These include timely transfer of imaging data from the image acquisition site to a central reading site, timely reading of medical images by central readers, establishing and following protocols for missing data, and de-identification of image sets. [i] There are two important performance metrics:

• Percent of site queries (i.e., percentage of images that are tagged by the imaging manager as having an issue and must be referred back to the clinical site),
• and percent of non-evaluable images (i.e., percentage of images that are not able to be evaluated by readers due to suboptimal data or incorrect data format).

Both metrics can be an indicator of insufficient site training and are often easily rectified through additional education.

Conclusion

As is often the case, too much data and not enough actionable information can lead to poor decisions and potentially put the trial at risk.  Fortunately, electronic solutions are facilitating the flow of data and performance metrics into analytic reporting tools that help answer important questions about trial risk, study progression, and vendor and site performance, like Median’s Online Reporting Portal. Most trials are looking at standardization to optimize efficiencies in clinical trial management while making better utilization of resources. [ii] The ability to measure these changes and take early action to improve deficiencies go to the heart of where the industry is heading.

Resources

[i] Yankeelov TE, Mankoff DA, Schwartz LH, et al. (2016) Clin Cancer Res. 22, 284-290.

[ii] Sullivan LB. (2016) Applied Clinical Tls Online. Standardized Metrics for Better Risk Management.