In our recent webinar, Enabling Decentralized Clinical Trials with Seamless, Remote Integration of Devices and eClinical Systems, representatives from Bioclinica, Masimo and Adaptive Clinical Systems discussed the challenges with integrating data collected from remote devices during decentralized clinical trials (DCTs).

This is top of mind for many companies as they shifted to virtual and remote trials during the pandemic. In fact, 57% of the attendees have utilized remote patient monitoring devices in their clinical trials, and 42% stated that they are well on their way to having 25-75% of their clinical trials having fully interoperable remote patient monitoring in place by 2023. However, 42% also stated that their organizations are still considering strategies: 50% of attendees are waiting for best practices or standards to emerge for adopting remote patient monitoring, and 40% are unsure of the ROI. Do the benefits of remote patient monitoring outweigh the costs of implementation?

To hear the answer to that and the speaker recommendations and view the demonstration, watch the on-demand webinar. Here, we present the questions from the audience, along with answers from the speakers.

Q1. What are the best practices for selecting remote patient monitoring partners for DCTs?

A1. It’s important to make sure that the device fits the workflow for the protocol or patient care process, whether it is a specific procedure being used by the researcher or the patient having to understand how to use the technology. If it doesn’t fit, it will most likely not be used.

Q2. When the patient is the source in a DCT, what are the best practices for transferring data from remote patient monitoring devices?

Q2. First, make sure to set aside time to prepare and plan for the intended device use: Will it be used for continuous monitoring to capture outliers or event-based monitoring? The volume and velocity of the data captured are likely to be large, and incorporating automation will help with data management. In addition, remote patient monitoring devices provide the ability to capture composite endpoints — telemetry from the patient monitoring tool or patient-reported outcomes such as pain levels. These newly available, up-to-the-minute endpoints contribute a level of data that can be particularly insightful but difficult to manage unless there is forward planning. Therefore, it is important to understand the data you’re trying to collect, the quantity of those data that will be transferred and how you plan on using the collected data.

Q3. Why is interoperability critical for data management of diverse monitoring sources?

A3. The number of systems has grown exponentially: the point solution, monitoring devices, laboratory data, eSource, ePRO, eConsent. While all of these contribute to the productivity of clinical trials; they can also contribute to data fragmentation. Furthermore, without appropriate integration into the EDC, all of these data accumulate at sites and create a greater workload.

Addressing this fragmentation as well as unstable integrations from multiple patients and multiple data sources, usable and easily repeatable interoperability is necessary. You want to be able to reuse the integrations for multiple studies at multiple sites.

Easy, repeatable and robust interoperability also reduces the need for data cleaning, reconciliation and verification — tasks that are becoming more challenging with the volume of data being collected as well as the shorter end-of-study timelines.

Q4. What are the remaining challenges facing the industry in the conduct of DCTs?

A4. There are several challenges remaining. One is the data transfer agreement, which can limit data use even if the technology is able to provide the data. Sponsors should enter an agreement with a very clear indication of data ownership, what they are allowed to do with the data and how often data are provided by the CRO. At the same time, CROs should understand their agreements with the sites.

Because of the reduced need for source data verification and reconciliation, changes might be required to internal data management processes. Instead of looking at the minutiae of the data, your data managers can take on roles of data analysts and data scientists.

Resistance to change also remains a large challenge. While COVID accelerated the use of remote monitoring, many companies still haven’t moved past the planning phase to the implementation phase. An easy transition can include the use of a simple device, such as those provided by Masimo, to monitor vital signs. Then, later trials can incorporate more devices and data after you’ve had experience with integrations and data handling. It’s important to keep an open mind and find a vendor who is ready to work with you to implement a solution that works with your protocol and existing systems.

With data integration and interoperability, security becomes paramount, particularly if clinical trials cross borders. There might be different privacy laws based on geography, and the regulatory requirements need to be taken into account.

Q5. How do you recommend managing multiregional data privacy regulations? What are the most common challenges?

A5. Data privacy regulations significantly vary between states and countries. The clinical team must establish a plan based on site locations. In some instances, data must be captured differently, and in others, it must be captured on paper. Forming an efficient plan is essential for success.

Contact us to learn more about how Bioclinica Outcomes can support your studies.