How digital health technology can help clinical trials be more inclusive and accessible
Oliver Eden | | 5 min read | Practical
When deployed strategically and designed with intention, healthcare technologies excel at solving delivery challenges and pushing back on traditional boundaries. Clinical trials are shifting towards a decentralized structure, thanks to digital technology’s potential for improving data collection, enrollment, and participation metrics. They also provide powerful methods for expanding diversity in methodologies, geographies, and populations. Though the COVID-19 pandemic accelerated the shift from traditional research practices to hybrid or decentralized clinical trials (DCTs), it is the resulting improvements and expansions in patient engagement that support longer-term momentum.
Today’s digital healthcare technology offers study sponsors a highly effective toolset for the centralized acquisition of data to support their study’s defined scientific endpoints. A drug delivery device that can capture and report accurate, objective data is an obvious improvement over manual self-reporting. However, self-administration in the home setting can be challenging simply due to limited oversight and the fact that human beings can be unpredictable when dealing with program instructions – not to mention potentially unfamiliar technology. Just as drugs don’t work in patients who don’t take them, digital health technologies won’t deliver value if patients can’t use them.
As a manufacturing solutions provider of smart, connected systems in pharmaceutical delivery, Jabil engineers prioritize patient-centricity in device design, often weighing the balance between the benefits of digital features and the capabilities of the patient population. Recently, when developing a reusable autoinjector platform, the Jabil product team asked, “What is the best way to fully harness the device’s data-capture capabilities with the smallest burden on patients?”
We had the challenge of developing the product with a smartphone app as the communication method; however, as we investigated the typical application of the device, we realized that our patient demographic was mostly 55 and older and typically had other medical challenges. This group are also the most technically challenged and have the poorest smartphone penetration, which means we needed alternatives.
The cost of convenience
Currently, many market-leading autoinjector platforms require smartphones for data transmission. Though seemingly convenient, smartphone penetration varies significantly by geography, demographics, and socioeconomic status. Even in an advanced country like the US, smartphone penetration in over-65s – a key market for healthcare – is only 61 percent, according to research from PEW. Throughout the developed and developing world, coverage gaps exist and must be considered.
From a patient-centric perspective, consider these limitations to smartphone-required connectivity:
- More involved initial training required for participants and caregivers.
- Study investigators and participants must download a smartphone app and be competent at pairing their device.
- The autoinjector and smartphone must be co-located for data transfer.
- Smartphone ownership becomes an inclusion criterion in the study design – or one must be provided by the sponsor.
- Technical troubleshooting must be timely, responsive, and “on call” throughout the study period.
- Each time the patient interacts with the app (to push data to the smartphone), it becomes an overt reminder that they are being monitored, impacting patient behavior.
This final point is particularly challenging because it introduces bias to the patient population. Together, these challenges raise the potential for additional study costs or time to complete enrollment, as well as the potential for limiting the demographic and geographic diversity of study populations. At a time when clinical trials strive to be more inclusive, the benefits of technology should not be prioritized over simplicity and inclusion.
Innovation has the chance to dramatically improve studies through collection of richer, more robust data – but, if the technology solution is not available to all, it limits enrollment and risks stratification in the data. For a connected autoinjector to deliver on its promise, it does not need hard-to-read touchscreens, smartphone apps, or other interface features that will require additional training for the patient or caregiver and ongoing IT support.
Our engineers determined that the most patient-centric option would be data transmission via cellular networks, which offers exceptional accessibility with greater than 95 percent coverage globally. But what is the easiest data transmission trigger? We settled on a docking station for after-use storage of our connected autoinjector.
Both the connected and non-connected versions of the autoinjector platform are intentionally designed to look and feel the same, with the connected version’s electronics integrated into the same form factor. In other words, users of either version follow the same steps and grip function without requiring additional training. The connectivity benefit is fulfilled simply by placing the device back into a “home hub” docking station that initiates the automatic transfer of injection event data and charges the device for its next use.
A typical drug trial can take more than a decade and cost over a billion dollars, with many failing to meet enrollment timelines or terminating due to participation challenges. It’s more important than ever to make sure your trials are as accessible as possible. As part of diversity research in clinical trials, Pfizer recently reported that Black Americans make up 13 percent of the US population, but just 5 percent of clinical trial participants – and the gap is even worse for Hispanic or Latino Americans. After decades of low representation, government bodies and trial managers are determined to expand participation diversity.
Research from IDC predicts that, by 2025, 75 percent of trials will be patient-centric DCTs; 90 percent of those will be hybrid and at least 10 percent will be virtual, driven by 30 percent growth in connected health technologies. Separately, McKinsey reports that 89 percent of participants in their Clinical Operations Roundtable expect to run a trial with most activities conducted in participants’ homes.
Although innovation is critical to digital healthcare, it’s also important that pharma companies and device manufacturers not leapfrog their patients’ ability to use technology. Will a patient’s experience with the device be easy and familiar? Will they be able to figure out device protocols intuitively or are they facing an uphill battle with a 30-page, fine-print IFU document? Whatever innovations may be embedded into a particular delivery solution, form should serve function. Or, put another way, if you do well by the patient, you will do well by the science.