One of the pillars of every successful clinical trial is the instruments used in the research process. They help measure vital signs, monitor and characterize diseases, and evaluate the effectiveness of treatments. Like many other aspects of clinical trials, these instruments have undergone significant changes due to technological advancements in recent years. Fortunately, all of the changes were for the better.
The instruments evolved into wearable health and medical monitoring devices that offer more benefits to healthcare and clinical researchers than ever. Thanks to these advantages, they’ve gained momentum in the community, which shows no sign of slowing down. Experts expect the market for these devices will be worth as much as $139.4bn in 2026.
To that end, this article will explore the role and potential of wearable healthcare technology in clinical trials. It will explain what they are and discuss their advantages and disadvantages and the overall future in the clinical research industry.
Keep reading to learn more.
What Is Wearable Technology?
Before we dive into the specifics, we have to understand what these wearable technologies are. Wearable technology or wearables are electronic devices that collect data about users’ health. They got their name due to their function of being worn on the body. In this way, their design allows for real-time data collection, more accurate assessments and precise results.
These patient-facing innovations come in various shapes and forms. The lineup includes multiple gadgets, jewelry, sports watches, chest straps, and even clothing items. They can be any accessory with a sensor capable of collecting health-related data. Good examples of these types of devices are Withings ScanWatch, with ECG and SpO2 sensors,
and FitBit products.
Wearable devices are usually connected to software that stores and organizes all the information they gather. The software allows researchers to gain quick access to the data, keep track of all developments in real-time, and make rapid and informed conclusions. Apple’s open-source software framework called ResearchKit is an example of one such product. This system enables researchers to create apps that can retrieve data through smartphones or wearable devices according to their research needs.
Role of Wearables in Clinical Trials
Clinical trial participants typically receive therapy for diseases they live with every day. They cannot help but be affected by real-world settings. Their symptoms vary depending on their daily life activities and various environmental effects. It follows that the data collected in these circumstances wouldn’t be the same as that captured in hospitals or research centers. That’s because both examples are controlled environments without diverse influences that are integral to everyday life. That’s where wearables come into the picture.
As mentioned earlier, wearable health monitors can fit into a single smartphone app that tracks and records health-related data in real-time in a natural setting. Since they operate continuously, they can create larger data samples and give researchers a clearer picture of the patient’s health and performance. This fast access to contextual, more detailed and precise data will help improve the research accuracy.
Benefits of Using Wearables In Clinical Trials
Now that we’ve gone over the basics, let’s consider all the benefits wearable healthcare technology brings to the table:
Objectivity — Wearables allow researchers to follow their patients’ responses to treatment in the real world. In that way, they can better understand the patients’ health status and the effectiveness of the tested drugs or therapy.
Timely decision-making — Access to continuous, real-time data can give researchers insight into the success of the treatment they’re implementing in the trial. They can make decisions on changing the trial’s protocols appropriately. For example, they can improve the effectiveness of the therapy much earlier than they would otherwise.
Accurate interventions — Real-time monitoring can also help researchers react promptly in case of adverse events or patients’ non-compliance. The former will help avoid serious health hazards, and the latter will improve the trial’s efficacy in the long run.
Improved patient recruitment — Many patients are reluctant to enroll in trials because they lack free time, transportation, or finances to constantly visit research centers and receive treatment. Wearables provide data clinical trials necessitate without burdening the patients with these requirements.
Better patient retention — Subject retention is another problem research trials struggle with nowadays. Wearables can help reduce the number of trial drop-outs by informing them about their progress in the trial. These devices can deliver prompts and share vital information to encourage compliance and active participation.
Optimized patient experience — Wearables free patients from keeping manual records of their health status. They also don’t require them to remember detailed information about their day-to-day response to treatment. The devices collect data electronically and automatically.
Lower costs — It’s no secret clinical trials can be expensive. However, wearable technology can significantly reduce these costs. They eliminate clinic visits and make room for different approaches to research and new information.
Increased Use of Wearables in Clinical Trials
The benefits we’ve discussed above have prompted many pharmaceutical and biotechnology sponsors to start using wearables already. Around 1,400 trials have leveraged these devices so far. Some of the examples include studies around asthma, diabetes, cancer, and schizophrenia patients.
For instance, a cancer center has employed a cloud-based analytics company’s products to assess the effects of myeloma on patients’ life quality. The wearable devices tracked the patients’ activity and sleep patterns, and the accompanying mobile app’s surveys collected data on their fatigue and appetite.
Challenges of Using Mobile Health in Clinical Trials
We’ve already established that wearables can be extremely useful for clinical research. However, it’s important to note that this technology also has some disadvantages. Take a look at them below:
Security and privacy — Storing data digitally comes with a risk of sensitive information leaks.
Data accuracy and validity — Patients tampering with or not wearing the device at all relevant times during the trial can have major detrimental effects on the trial’s results.
Ethical issues — Wearable technology automatically collects a great deal of sensitive information on patients. The system requires you to obtain approval to generate and own that information, which can be difficult.
Effective implementation — Wearable technology is still relatively novel in the clinical research community. So, it might be challenging to implement it on a global scale adequately.
Conclusion
Wearable health and medical monitoring devices are tools rapidly gaining traction in the clinical research industry. They come with many benefits for the researchers and patients involved in trials. On the one hand, they provide researchers with access to continuous, contextual data they can use to personalize treatments and deliver more accurate results. On the other hand, they encourage patients’ enrollment and participation in the research and offer them a more manageable and convenient experience.
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