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It’s no secret the pandemic has played a hand in changing the way clinical trials are conducted - starting with the abrupt shift to hybrid models. However, this shift has naturally progressed long before the pandemic due to the challenges that plague traditional clinical research models: low participant reach, on-site operational costs, manual data collection and loss of data, and early study termination – potentially due to a combination of these challenges. Today, the majority of our clinical research customers are utilizing a hybrid model for a few reasons that we’ll share in this article, and we’ll explore how the ZEPHYRx Spirometry Cloud Platform has evolved to help advance hybrid clinical research.
It’s all About the Participant
Researchers strive to create participant centric study models by reducing burden. 70 percent of potential trial participants in the U.S. live more than two hours away from the nearest study center, impacting their willingness and ability to participate.1 For those with respiratory conditions, nearly 5.5 million Americans live in ‘pulmonary deserts’ and travel an hour or more to the closest pulmonologist.2 With a hybrid model, researchers can reach these participants with a remote respiratory monitoring (RRM) solution. This can not only increase participation and participant diversity, but also increase participant satisfaction leading to a reduction in dropouts.
Data quality and consistency are of top priority for clinical trials, followed by obtaining more robust data points and securely accessing that data in real-time. Without a remote component, pulmonary function testing occurs when participants are on-site making it difficult to understand disease progression day to day and week to week. With RRM, participants can perform spirometry anytime, anywhere with data sent to the research team securely, in real time. This enables researchers to obtain more clinically meaningful data to better monitor the participant, track disease progression and treatment response, and proactively adjust treatment plans.
It can cost anywhere from $161M to $2B+ to bring a new drug to market. Overall, the factors that contribute the most to costs across all trial phases include Clinical Procedure Costs (15 to 22 percent), Administrative Staff Costs (11 to 29 percent), Site Monitoring Costs (9 to 14 percent), Site Retention Costs (9 to 16 percent), and Central Laboratory Costs (4 to 12 percent).3 In addition, the average clinical trial site visit for chronic disease may be $3-7k per patient. These costs are major obstacles to conducting clinical research, much of which may be avoided with a hybrid model.
The hybrid clinical trial is a mix of traditional on-site participant visits and telehealth. For trials using spirometry, the on-site visits typically occur during the screening and randomization process with participants using a remote solution for the remainder of the trial. This can pose a few challenges if the right solution is not in place.
On-site screenings typically utilize traditional lab spirometry equipment while remote spirometry uses a personal spirometer. Data generated from different devices may be of concern for data consistency. Ideally, trials would use the same device platform for both on-site and remote spirometry.
Disparate data is also of concern since these devices are likely not connected to the same cloud platform, with some lab devices offering no connection leading to manual data transfer. Ideally, all devices are connected to a cloud platform and accessible from a provider dashboard.
Oftentimes, clinical trials do not have a dedicated overreader to review pulmonary function test (PFT) results at the time the test is taken. With traditional processes, the results are printed and faxed or securely emailed to the overreader for analysis. This process can take weeks before the study team receives confirmation that the test needs to be repeated, wasting valuable time.
Participant adherence can be challenging with any remote testing, especially when they have to record their own data.
The ZEPHYRx Spirometry Cloud is an all-in-one platform for organizations to effectively orchestrate all the moving parts of their respiratory clinical trial - whether it’s on-site screening, remote monitoring, or data integration. Our solutions are connected to the same cloud platform with a web-based Provider Dashboard enabling study teams to access their participant’s spirometry data in real-time.
Kiosk is a cloud solution for efficient and cost-effective point-of-care spirometry.
This solution enables study teams to screen participants on-site using the same device technology and platform that they will use for their remote PFTs throughout the trial. This ensures data consistency and real-time data sharing from all devices to one interface.
Here’s how it works…
The MIR Spirobank® II Smart BLE Spirometer is FDA-cleared for multi patient use and HIPAA compliant with no data stored on the device. Researchers can use one spirometer for all of their screening needs because this device offers a disposable mouthpiece that can be changed out for each participant – a cost-effective alternative to traditional lab spirometry. Additionally, studies have shown that the data is equivalent to traditional lab spirometry – visit zephyrx.com/studies to learn more. Measurements include FVC, FEV1, FEV1/FVC%, and more*. This Bluetooth spirometer pairs with the Kiosk app to share data in real-time.
The Kiosk App boasts an intuitive interface for both the study team and the participant, and is HIPAA compliant with no data stored on the device. The study team simply enters the participant’s information into the app, the participant conducts their PFT with results sent to a secure cloud platform and accessible in real-time through both the Kiosk app and provider dashboard. Every effort is assessed using ATS/ERS 2019 standards of spirometry so the study team will know instantly if the effort was acceptable, with the ability to accept or reject efforts as needed. They can take a deeper dive and see details on why an effort was acceptable, usable or unacceptable.
The Provider Dashboard is an intuitive interface for study teams to access all of their participant’s PFT data with key measurements graphed for each result. Study teams can create customizable data reports with a downloadable PDF for EMR documentation.
With just one spirometer and the Kiosk app, the study team can easily and quickly screen a large participant population.
Now that we’ve reviewed our on-site screening solution, let’s explore our remote monitoring offering…
Extend pulmonary function testing beyond the study site to wherever participants are. With their own personal spirometer connected via Bluetooth to a mobile app, PFTs can be performed anytime. With remote spirometry, study teams can decrease participant travel burden, increase participation, reduce dropouts, and reduce on-site expenses.
Here’s how it works…
The MIR Spirobank® Smart Spirometer is FDA-cleared for single-patient use. Each participant will have their own personal spirometer connected to the ZEPHYRx Breathe Easy app on their own mobile device, or on a study-provided phone or tablet. It offers the same important measurements and data quality as the Spirobank® II Smart BLE Spirometer.
The Breathe Easy App is a free, participant-facing mobile app offering endless engagement from automated PFT notifications to real-time video coaching to 8+ breathing exercise games. Participants receive step-by-step PFT instructions with on-screen messages to help them throughout the process.
The Provider Dashboard offers industry leading features for remote respiratory monitoring programs:
• Real-time Video Coaching is a built in video call feature enabling study teams to coach patients virtually through their PFT.
• PFT Task Reminders & Notifications enable care teams to schedule automated PFT task reminders to increase adherence. The notification is sent directly to the Breathe Easy app and home screen of the participant’s mobile device.
• The Overreading Dashboard is a separate interface for a more efficient overreading process. Eliminate printing and faxing results to overreaders and wasting valuable time. Overreaders can receive a notification and log into their own dashboard to analyze and accept or reject efforts, and notify research coordinators of these results.
• Custom Surveys & ePROs are available in the dashboard. Create and deliver custom surveys and collect ePROs directly through the Breathe Easy app.
Now that we’ve reviewed our remote respiratory monitoring solution, let’s explore our integration offering…
Gateway enables clinical trials to simply plug-n-play a proven solution or integrate data into their preferred system. Some clinical trials have a remote patient monitoring platform in place and prefer to add a respiratory component to that existing system. For those customers, Gateway enables them to easily plug our solution into their existing platform making it seamless for the participant.
Other customers prefer to access the participant’s PFT data from their own clinical trial management system rather than from the provider dashboard. We’ve developed a simple API for a fast and easy integration process.
At the end of the day, clinical trials are trying to reduce the time it takes to bring drugs and devices to market, and help treat patients. With the right hybrid model and technology partner, you can deliver the same standard of care remotely as participants would receive on-site. Choosing the right partner is critical for a successful program.
GET IN TOUCH
Visit zephyrx.com/contact to schedule a demo or request additional information.
We offer the project management support research teams need to roll out a successful clinical trial.
• Kickoff & project planning
• Ongoing project status meetings
• Documentation for IRB & DSMB reviews
• Study-specific ZEPHYRx training
• Data transfer requirements setup and delivery
• Participant onboarding & logistical support
Mike DiCesare is an entrepreneur, holder of multiple utility patents, and has received the “Forty Under Forty” award from Albany Business Review. Mike cofounded My Music Machines in 2007 and created the Jamboxx - a breath-controlled musical instrument. This led to an NIH/NHLBI funded STTR grant to develop a novel device for respiratory therapy using interactive gaming and music, for which Mike was the Principal Investigator. This research spawned Mike’s next company in 2019 – ZEPHYRx, a cloud spirometry platform enabling healthcare practices and clinical trials to remotely monitor their patient’s respiratory health.
1. Tenaerts, Dr. Pamela. “Can Decentralized Clinical Trials Improve Patient Diversity?” ACRP, Apr. 2021. https://acrpnet.org/2021/04/16/can-decentralized-clinical-trials-improve-patient-diversity/
2. Brooks, Amanda. “Mapping Pulmonary Deserts: Where are Americans Having Trouble Getting Lung Care.” GoodRx Health, Aug. 2022. https://www.goodrx.com/healthcare-access/research/pulmonology-deserts
3. Sertkaya, Aylin., et al. “Examination of Clinical Trial Costs and Barriers for Drug Development.” ASPE, Jul. 2014. https://aspe.hhs.gov/reports/examination-clinical-trial-costs-barriers-drug-development-0