mHealth innovation: Identifying the best patient-centered technology for clinical trials
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
Plus, these technologies offer additional benefits of improving the overall patient experience, resulting in higher patient recruitment, engagement, and retention. Eighty-nine percent of sponsors that use wearable devices in clinical trials say that patient feedback has been positive.
But patient-centered technologies are not created equal. What works for one patient population may not be appropriate for others. Thorough testing and careful evaluation are essential prerequisites for identifying the best technology for a company’s trial needs.
I recently moderated a webinar that took a closer look at the use of wearable devices for clinical trials. The interactive discussion featured my sensors and wearables colleagues from Parexel and Actigraph, a provider of medical-grade biometric monitoring technology solutions.
We shared insights from market research on sponsor usage of wearables and sensors. The research study’s goal was to develop a deeper understanding of the current trends and sponsor adoption behavior for wearable devices in clinical trials. All 140+ survey participants work for a biopharmaceutical company in some capacity and are involved with decision making for procuring and/or selecting an external provider for clinical outsourcing needs.
Bringing the future of clinical trials to the present
Sixty-seven percent of the companies represented in the survey said they are currently using wearable devices in clinical research for remote data collection from patients in their home environment, with oncology and cardiovascular disease studies representing the highest adoption rates. One-quarter are considering wearable devices for future clinical trials.
The pandemic has rapidly accelerated the use of wearables in clinical trials. This has especially been the case for fully decentralized clinical trials (DCTs) where the patient participates entirely from their home or local community; as well as for hybrid trials offering a combination of site and home-based participation.
At Parexel, we guide sponsors through scientific considerations and operational requirements for the successful use of mHealth (mobile health) devices in clinical research. We have been at the forefront of wearable, mobile technology even prior to the pandemic. My colleague Rosamund Round, leader of Parexel’s Patient Innovation Center, recently spoke about Parexel’s work with DCTs.
In an interview with Contract Pharma magazine, Round said, “Parexel now includes DCT in 80% of phase II/III and 100% of phase IV proposals. We see DCT as the centerpiece of a new operating model and how we can best support patients in or near their home to improve trial access and experiences.”
Leveraging the right tech at the right time
Many companies are leveraging wearable devices because of their potential to reduce study costs, ability to track data that could not be viably obtained in a clinical setting otherwise and to deliver patient-centric research approaches. But mHealth infrastructure and operationalization need to be right for this approach to be effective.
Ease of use for the patient and data quality are the two top attributes that survey respondents consider when selecting a wearable device to use in a clinical trial. Solutions architect and program director at Parexel’s Scientific Data Organization Nathan Noakes advised that starting with the right technology is critical.
“You need to be sure that the type of device that you are selecting is the right one for the protocol, the right one for the patient, and is going to give you the endpoints and the outputs that you are expecting,” said Noakes.
Parexel maintains a device catalog of wearables and connected devices that have been assessed for deployment in clinical trials. To date, this includes more than 70 devices across therapeutic areas, 57 of which are medical-grade devices. All Parexel vendors are audited and qualified to ensure they meet strict data protection and privacy requirements and are following robust processes for manufacturing and implementation.
All data from the wearable devices are ingested into a platform. This is usually via a data hub placed in the patient’s home or through an app on the patient’s own or provisioned smartphone.
The collected data are visualized and reported through an online portal and reviewed remotely. If more context is needed, especially for DCTs, other patient-reported technologies like eDiaries, ePRO/eCOA and eConsent can be overlayed onto the data to provide additional insights.
Enabling greater visibility into patient wellness
The massive amounts of data obtained through these technology platforms inform clinical decisions on a patient’s treatment such as dose requirements and therapy changes. Expanded data sets provide additional learnings that guide the entire trial.
Jeremy Wyatt, CEO of ActiGraph, said that wearable sensors offer “… a much more granular view into the patient and a better opportunity to understand what’s going on in the patient’s life, rather than just what some biomarker tells us about a blood sample.” That granular view of the data provides high value to sponsors, investigators and regulatory authorities. The ability to capture digital endpoints that can’t be collected in other ways are the primary drivers of using wearable devices in clinical trials.
Respondents to the survey cited the top three benefits of including wearable devices in clinical trials as improved data quality, obtaining data that can’t be obtained from other methods and better patient compliance. More than half of respondents reported that heart rate and blood pressure are the top measurements currently captured through wearable devices. Heart rate and blood pressure were followed by measurements of temperature, heart rhythm, ECG/EKG, blood glucose, steps and sleep. The data for these types of outcomes tend to be more easily captured via wearables versus non-wearables.
Reducing the patient burden
The reality is that the success of a clinical trial using wearables hinges on the patient. The process must be as seamless as possible for them.
Our research findings suggest that survey respondents believe that patients find wearable and connected devices appealing. Most like the reduction in the number of trial site visits that are required by using a DCT model with telehealth options. This engagement leads to both easier recruitment and increased retention of patients.
Feedback from sponsors is encouraging, as well. Eighty-nine percent report that patient reactions have been positive with China seeing more favorable feedback than the other geographies surveyed including North America and Europe.
Findings show that to drive patient retention and compliance, the device must be easy to use and fit into an existing lifestyle. Patients have to see the value in the device and the data collected and how it facilitates their health. Certain methods can help drive usage, like:
- Including customizable device attachments to ensure patient compatibility such as various sizes for body types or options for wrist, waist or hip.
- Ensuring variable sensor controls capture the appropriate data over the device’s required battery life or between recharges.
- Providing available support including “hypercare” during the initial enrollment and ongoing 24/7 helpdesk staff.
- Offering robust, easy-to-interpret training materials for use of the device and collecting data.
A promising future for wearables
A workgroup convened by two of the National Institutes of Health’s Big Data to Knowledge (BD2K) Centers of Excellence evaluated the clinical application of wearables. The resulting article found that “… the future remains promising for wearables in healthcare.”
The group expects the utilization of wearables in healthcare environments to increase as the technology advances and interest expands. They also anticipate the integration of wearable sensors into clothing and footwear will eliminate compliance limitations while improvements in sensor accuracy will increase their use in the medical environment.
The evaluation concluded, “Overall, wearables herald a new era in healthcare delivery with the potential to transform many aspects of clinical care.”