2021 年 9 月 10 日

Reducing Clinical Trial Lab Data Variability through EDC

Imagine you’re in charge of running multiple international banks. And each of those banks processes multiple transactions every day that require currency conversions. Would you ask the tellers at each site to manually convert each deposit, withdrawal, transfer, etc. before completing the transaction?

Of course you wouldn’t. To ensure the correct amounts are being processed your staff would rely on automated currency converters, which ensure correct amounts are processed and recorded every time.

The same concept is true in clinical trials that use EDC systems to capture data from local labs. We explore how it works and the benefits it delivers here.

Background

Local laboratories are commonly used in clinical trials because they are on-site or close to the investigator site, and they often provide data that are needed immediately for treatment or randomization decisions.

But, as studies are conducted around the globe, there are differences in the instruments that local labs use and the units of measurement they produce. Instruments can be calibrated differently, use different reagents, use different units of measure and normal ranges. This makes direct comparisons of lab values across local laboratory sites difficult and introduces additional time required by investigative sites to manually convert values to ensure their consistency and compliance with the protocol.

Dianne Piccone Cologne and Clinical Trial lab data

“By leveraging an EDC local labs module, lab data can be captured and normalized across patients so that medical monitors and study teams can look at the data holistically.”

– Dianne Piccone, Director, Solution Consulting, Calyx

So, how do you prevent the data variability, increased site staff burden, and potential trial delays that arise when local laboratories are used in clinical trials?

The EDC Local Labs Module

By leveraging a local labs module within an Electronic Data System (EDC), lab data can be captured as it is provided and then normalized across patients and throughout the study so that medical monitors and study teams can look at the data holistically, to identify safety findings and trends.

Local lab results are entered into the system, then pre-configured conversion factors normalize the data, in real-time, into a common standard unit. Normal reference range values for each lab test, with gender and age attributes can be maintained, and the system produces an alert for out-of-range values. Lab data sets can also be exported at any time for analysis.

Data Normalization Benefits

A local labs module within an EDC system allows study teams to gain important information earlier with a glimpse into the overall dataset sooner. Study teams can identify and overcome common issues in data collection to avoid an accumulation of errors or inefficiencies upon the closeout of a clinical trial.

Summary

For many clinical trials, laboratory data comprises a large portion of all data collected. It can be inherently complex, and the time it takes to manually normalize it could be better spent by an investigative staff meeting other clinical trial requirements.

By leveraging a local labs module within an EDC system, trial sponsors normalize the collection of disparate lab value, simplify processes for site staff, and ensure the validity of the important clinical trial data.

And that’s value you can bank on.


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