The increasing ubiquity of mobile and wearable devices has been noticeable in the last decade, with devices finding applications in many different industries. But perhaps the most meaningful application is in medical research, where these technologies can make the biggest difference. Let's take a look at how mobile technology and wearables are being leveraged in clinical trial data management.
Understanding Decentralized Clinical Trials
The general public has a clear notion of clinical trial settings and practices, but in a world of fast-developing technologies, this has met with disruption.
What are Decentralized Clinical Trials?
Decentralized clinical trials (DCTs) are those that subvert the traditional paradigm of on-site clinical trials by increasing the number of activities that are taken directly to the patient. There is also the potential for combining centralized and decentralized processes, whereby trials are conducted by mobile clinicians during in-person visits or at mobile clinics.
Due to the physical distancing and travel restrictions of the COVID-19 pandemic, with access to trial sites reduced by 80 percent, DCTs dramatically increased. Technology for remote clinical trials was progressing before the pandemic but was not in such common practice. The pandemic and its disruption led to the rapid mobilization of virtualized processes, such as at-home phlebotomy and videoconference assessments.
How Do Mobile and Wearables Work for Decentralized Clinical Trials?
Newly developed technologies for DCTs include electronic consent (eConsent), remote patient monitoring, telehealthcare, electronic health (eHealth) records, telemedicine, and electronic clinical outcome assessments (eCOA). Mobile and wearable technology can be used for many of these new approaches to clinical trials, and potentially for the detection and interpretation of adverse events, phenotyping, and recruitment of participants for clinical trials.
Wearable technology in clinical trials includes hardware such as sports watches, chest straps, patches, monitoring devices, and wearable sensors like pulse oximeters. Such devices make it possible to measure and monitor health data like heart and respiratory rates, physical activity, posture, and blood oxygen saturation levels. Wearables are used in conjunction with mobile apps that can collect and store data over time.
High-quality clinical trial data management is essential to ensuring the success of DCTs. Choosing a reliable clinical services provider means that researchers can improve the efficiency and quality of trials using multiple supply streams.
In 2020, The Food and Drug Administration (FDA) relaxed regulations regarding patient monitoring in response to the pandemic, which paved the way for a new era for the decentralized clinical trial model.
The Benefits of Wearables and Mobile Devices for Clinical Trials
As with many other forms of digital technology, wearables and mobile devices can considerably increase the efficiency of clinical trials. This has a huge impact on the clinical trial data management process which delivers important insights to the health care industry.
How Do Wearables and Mobile Devices Manage Data?
Wearable devices, like smart sensors and patches, are data collection endpoints that transfer the raw data recorded to devices where the database is held. This could be a smartphone or laptop for the use of storage and interpretation. Processing, analytics, and data security are additional requirements, which can be addressed by an all-in-one cloud-based service, such as an integrated cloud management solution.
The key benefits of using wearables and mobile devices for clinical trials include the following:
Time and Cost Reduction
This can be noticed in time and cost savings for both the sponsor and the patient. Currently, 70 percent of clinical trial participants live at a distance of more than two hours’ travel time from trial sites. So digitization can eliminate unnecessary travel time and costs, while also widening the pool of potential patients in a trial. As tasks can be performed remotely, the workloads and expenses for trial investigators are also reduced.
Speed of Delivery
With the advantage of real-time continuous data, researchers can make decisions more quickly and based on participant response, for example, to a particular drug. In intervention studies, amendments to protocols may need to be first made for patients to receive faster treatment. Improved accuracy also means that researchers can be alerted to possible adverse events sooner.
Improved Data
While data collected at a center for clinical trials is limited in its depth and breadth, wearables and mobile technology provide patient data over time, which results in richer datasets offering deeper insights. Wearables also enable a level of data aggregation that opens the possibilities for observational studies to inform subsequent interventional studies and improve patient care.
Data for the Patient
For patients, the increased health data and insights can lead to increased participation in treatments and wellbeing, as well as greater convenience in medical care.
Use Cases
There are many examples of successful clinical trials in disparate fields of medicine, such as diabetes, asthma, Alzheimer’s disease, heart disease, arthritis, and cancer.
- Caretaker Medical developed a wireless finger cuff device that is used for monitoring continuous non-invasive blood pressure (CNIBP) as well as vital signs, and this integrates with HealthSaaS, a cloud-based patient monitoring platform. This technology was used in a 2017 clinical trial for patients undergoing major intra-abdominal surgery.
- In a recent Pfizer decentralized trial, data on the scratching of eczema patients during the night was gathered using wearable sensors for clinical trials, so there was no need for them to check in to a sleep clinic.
- The mHealth Screening to Prevent Strokes (mSToPS) was a randomized clinical trial that proved that for people at risk of atrial fibrillation, using an electrocardiogram (ESC) patch can improve the chances of an early stroke diagnosis.
Adoption of Mobile and Wearable Technology for Clinical Trials
The global clinical trials market is expected to grow at a rate of 5.7 percent per year from 2021 to 2028, which puts pressure on the development of more efficient and affordable practices. A study by Kaiser Associates projected that 70 percent of clinical trials will incorporate sensors by 2025. But the widespread adoption of wearables and mobile technology in decentralized clinical trials is still subject to governance and technological barriers.
Advancing Data in Clinical Research
Decentralized clinical trials are a natural evolution of the clinical trial model, and technologies that can be easily operated remotely are key to progress in the field. But although the potential for streamlining and improving clinical research processes is certain, there are still challenges in regulation, security, privacy, and the development of this technology. Wearables still need to be tested and validated, and scientists in research and development will be required to work more closely with device engineers to ensure the highest level of efficacy, speed, and accessibility.
With innovation as a priority, Mason is on hand to provide the dedicated devices, software, and infrastructure needed for decentralized clinical trials.
