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.

“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.

I’m often struck by how data collection through patient sensors varies from one trial to another. At one end of the spectrum, I’ve seen a sponsor define a very specific data collection and analysis process, whereby patient blood pressure data was collected at sites, kiosks, and at home through a mobile device; each single data point was integrated with Calyx EDC for analysis. At the other end of the spectrum, a different trial recorded activity and heart rate continuously through a wearable activity monitor; despite the continuous recordings, the only data points that were reported daily were the lowest, highest, and average heart rates for each patient. This latter example raises the question: what happened to the rest of the data and how are we using it?

The Clinical Trials Transformation Initiative (CTTI) recommendations on the Use of Mobile Technologies in Clinical Research (July 2018) include one particular recommendation that “only data that are necessary to meet the objectives of the trial should be collected.” There are some nuances within the recommendations, especially around exploratory endpoints, that may require the capture of data without knowing which data points will be the most valuable. However, CTTI is very clear that “when the study endpoints are well understood, CTTI recommends against speculative “data fishing.”

“It seems inevitable that, as a norm, patients will have to wear wearable devices to take part in clinical trials in the future.”

– Sr. Director, Voice of the Customer, Calyx

Going back to my example above about activity and heart rate monitoring, how do we set the boundary between strictly required data and “data fishing”? Considering that patients wear the device, no matter what data points are analyzed, is it frowned upon to collect more data points than strictly needed?

Although collecting more data than required doesn’t “hurt,” we must aim to not increase the patient burden. However, according to Kaiser Associates and Intel, 70% of clinical trials will incorporate sensors by 2025. So, it seems inevitable that, as a norm, patients will have to wear wearable devices to take part in clinical trials in the future.

What will we do with all this data? Will we store it in the attic, just in case, and forget about it? Or does it open new opportunities we are not aware of yet? For example, will we be able to access data in the future for retrospective analysis, or could it be used to refine patient selection for synthetic arms?

With the increasing use of real-world evidence and past trial data to build synthetic arms, we should ask ourselves what type of data we may need in the future. As data collected through wearable devices become primary data points, will the absence of at-home data points in current trials limit our future ability to build synthetic arms based on past trial data? Now going back to the recommendation from CTTI, some may feel that it is a limitation not only to what we can analyze now but potentially to how we could use the data in the future.

We are much more aware of the potential clinical trial data represents than we have been in the past. With the emergence of AI/ML in our industry, we may be about to witness the biggest revolution in clinical trials to date. As long as what we are aiming for benefits patients, and doesn’t increase the burden for those patients taking part in clinical trials, should we limit our ability to collect patient data? Or should we aim to set rules as to which data points should be collected with wearables?

In the world we’re living in today and the direction our industry is heading, there’s much to consider when it comes to the collection of clinical trial data by wearable devices.

The advances that have been made in consumer technologies have changed – and for the most part, improved – how we do almost everything. As those technologies have made their way into the clinical development arena, the benefits they offer to clinical trial sponsors and CROs have been significant.

However, some investigative site personnel and patients feel burdened by the amount of technology that’s involved in clinical trial participation. Here we explore the issue of tech fatigue and how electronic data capture (EDC) solutions can evolve to minimize some of the stressors impacting these critical clinical development stakeholders.

What is tech fatigue?

The Site Perspective

For investigative site personnel, technology fatigue relates to the increasing effort that’s required to keep up with the sheer amount of technology that’s being used within given protocols across their various clients.

Through interviews with site personnel, we’ve learned their biggest pain point is the management of the technical devices they’re required to store, inventory, charge, and distribute to clinical trial patients. These include electronic Patient Reported Outcomes (ePRO) devices, tablets, wearables, Holter monitors – the list goes on and on.

Since any given site could be running between 20 to hundreds of clinical trials at a given time, and any/every one of those trials could include a variety of devices, this can create a burden for site personnel. For every patient they are expected to enroll, across hundreds of studies, they could be managing up to a thousand different devices. In addition to needing space to store and charge the technology so it’s ready for patients at the appropriate time, they also need to log the inventory to ensure it’s returned to the correct sponsor/CRO at the end of the trial.

This extends to the respective owners’ manuals and training guides that accompany each of the devices, which site personnel need to ensure are the most up-to-date versions and available to provide their patients during enrollment.

“The solution to tech fatigue may lie in the advancement of today’s proven electronic data capture systems” 

– Mike Mendoza, EDC Expert

 

Trial patient burdens

Clinical trial patients can feel the stress of tech fatigue, too. In many cases, this stems from their understanding of the equipment’s expense and their fears of losing or damaging it, but equally from their eagerness to submit the best data possible amid uncertainty of whether they’re “doing it right.”

Their stressors are not only focused on the entry of the data but also its transmission – which again speaks to their desire to get this important data to the right place. Many sites often end up playing the role of tech support since some patients feel more comfortable calling their study coordinator than a technology providers’ help desk. Site personnel routinely field phone calls from patients with questions about using the devices, what to do when a Wi-Fi or cellular connection isn’t available, etc.

This then comes full circle in adding to the tech fatigue investigative site personnel are experiencing in today’s clinical trials.

How can EDC help?

But, what if EDC could do more? Perhaps by leveraging this integration capability to allow users to use their own equipment and normalize the information, or provide an inventory module that captures, in one place, information on all the devices site personnel are managing for all the studies they’re conducting?

And/or, envision an EDC application that serves as a portal for enrolled patients’ reference materials? Instead of having to store all owners’ manuals, training guides, etc., site personnel could go to one location to either print what’s needed, on-demand, or provide it via email to the patient.

The way technology is advancing – and based on our learnings of what patients and site personnel need to be successful – it’s possible to imagine that the solution to alleviating some of this tech fatigue may be right at our fingertips. We just need to focus on how to advance these familiar tools and collaborate to help these critical trial stakeholders do their important part in providing the data that’s paramount to clinical development success.

Unfortunately, I think the clinical development industry has been slower to adopt technology than has clinical practice. Many companies have fallen into the trap of doing things a certain way, just because it’s familiar and has become the default methodology. Calyx was formed to disrupt the status quo with new technology, and part of my role will be to help clients overcome their resistance to being early adopters of tools that will improve data collection, management, analysis, and submission.