Over the past few years, we’ve witnessed rapid advancements in healthcare technology used in clinical trials.
The COVID-19 pandemic acted as a catalyst, accelerating innovation and adoption in clinical research. As a result, we’re now seeing the uptake of successful decentralised and hybrid clinical trials worldwide, which are transforming the industry landscape.
Medical technologies help us take the trial to the patient, making clinical trials more patient-centric and accessible by enabling remote communication, real-time physiological monitoring, and efficient data collection and patient feedback.
However, with these advancements come future challenges, such as the risk of overreliance on technology leading to a loss of the human touch in clinical trials. The inaccessibility of technology to some populations also threatens to worsen inequality in patient representation instead of improving it.
In this guide, we will delve into the profound impact of technology on clinical trials, exploring the various technologies used, their reception by patients, and the red flags we must be vigilant about to ensure new technological developments in clinical trials genuinely enhance the patient experience and don’t undermine it.
Wearables and data collection in clinical trials
One of the most significant developments in recent times has been the widespread adoption of wearable devices, such as smartwatches and fitness trackers.
In 2022, the number of people worldwide owning wearable devices reached an astounding 1.1 billion. The integration of medically approved wearables into clinical trials has brought about revolutionary changes. Unlike their consumer counterparts, these approved medical technologies boast advanced capabilities, accurately measuring physiological changes like heart rate, glucose levels, and blood pressure in real-time and with granular detail.
This data can be used to continuously monitor a patient’s health status and promptly intervene if any potential problems arise.
Benefits of wearable technology in clinical trials
Wearable devices allow patients to feel more in control of their health, and, for many, the introduction of wearable technology has made participation in clinical trials more accessible and convenient, reducing the need to travel to sites, thus addressing some of the primary reasons patients drop out of clinical trials.
Read more on how disruptive technology is changing the clinical trials landscape.
Examples of medically approved wearable devices
The landscape of medically approved wearable devices is vast, with various types available for use in clinical trials.
Skin patches
External skin patches adhere to the skin and measure skin contractions to provide data on health indications such as heart rate, movement, muscle contractions, and breathing.
Smart pills
Once ingested by the patient, a Smart Pill sends health data from within their body to a healthcare practitioner, who can track the type of medication the patient has taken, when they took it, and how much of it is in their system.
Smartphones and smartwatches
Some clinical trials use commercially available technology, such as smartphones and smartwatches with compatible medical-grade add-on technology to detect physiological states and changes in movement and gait to detect diseases, including Parkinson’s.
Individual patient experiences with wearable technology may vary significantly. While some patients wholeheartedly embrace the use of wearable devices in their clinical trials, it is essential for Contract Research Organisations (CROs) and sponsors to listen to patients individually to understand whether wearable medical technology is appropriate for them.
The results obtained from wearable devices can be easily skewed if not worn or maintained correctly and consistently. Patients uncomfortable with advanced technology may feel alienated or unvalued if no alternatives are provided. Age, education, technical knowledge, and personal preferences can influence a patient’s willingness to accept Smart Devices as part of their clinical trial and their ability to use them correctly.
Failure to adhere to the correct protocols when using these devices, whether due to disengagement or lack of understanding, can significantly impact the trial results. As such, wearable technology must always be combined with tailored support for each patient and never as a stand-alone solution.
Wearable devices also only go so far and should be combined with regular at-home or site-based trial visits to work effectively. During at-home trial visits, practitioners can conduct more comprehensive assessments, perform necessary medical tests, and address participants’ concerns or questions. This combination empowers participants to actively engage in their healthcare journey and facilitates a deeper connection between patients and medical professionals.
Read more about how wearable devices are revolutionising the patient experience.
Telemedicine and mobile communications in clinical trials
70% of patients live more than two hours away from research sites, and the use of virtual components like telemedicine and remote patient monitoring in hybrid or decentralised trials opens up clinical trials to a broader demographic of patients worldwide.
While decentralised clinical trials have numerous advantages, such as reducing the need for patients to travel to sites and making trials more accessible for those with disabilities, they do not always present an ideal solution.
Certain aspects of trial management may be compromised due to reduced face-to-face contact, and maintaining effective communication with patients is crucial. Hybrid and decentralised trials use various communication methods, including video conferences, SMS reminders, app notifications, and phone calls with healthcare practitioners (HCPs), as well as updates about their scheduled in-person visits either at home or on-site.
As virtual interactions become increasingly common in patients’ lives, they expect technology to be user-friendly, visually appealing, and compatible with their existing devices. Therefore, it’s essential to ensure all communication platforms align with patients’ existing tech and are accessible and intuitive.
Mobile communication and healthcare technology have been generally well-received by many patients. However, providing technology alone is insufficient. In addition to training and guidance on the use of medical technology, patients expect to be supported by a healthcare practitioner at every stage of the clinical journey.
It’s important to remember that technology should enhance and complement the human element in clinical trials rather than replace it entirely.
Read more on maintaining effective communication with patients throughout decentralised clinical trials.
AI and big data in clinical trials
The clinical trials industry has long struggled with recruitment and retention issues, with approximately 80% of trials failing to meet their targets on time. AI is now being used to address this challenge.
By analysing vast amounts of patient data from medical records, AI can identify optimal candidates for clinical trials, significantly improving recruitment and retention rates. The use of AI in clinical trials is a welcome development, as the average dropout rate is around 30%.
AI’s capabilities extend beyond the enrollment process. Once patients have enrolled in a trial, AI can analyse communication data from patient interactions to predict potential early dropouts. This presents a tremendous opportunity for the clinical trials industry. AI insights with detailed feedback from healthcare practitioners working with patients during a trial can lead to more effective interventions and retention strategies.
Read more about how technology galvanises unrepresented patient populations.
How AI helps patient engagement in clinical trials
AI uses sophisticated linguistic pattern recognition to analyse patient speech during feedback provision. By combining semantic tagging (specific words used) with linguistic parsing (the sentiment within the context), machine learning algorithms can predict a patient’s behaviour, such as the likelihood of leaving the trial early. With this intelligence, clinical trial designers can adjust protocol to enhance the patient experience.
For example, if AI predicts that a candidate is fatigued due to long journeys to the trial site, designers could consider adopting a hybrid or at-home model, reducing travel burdens.
How AI analyses patient data in clinical trials
Another area where AI significantly impacts clinical trials is data analysis. Clinical trials often generate vast amounts of data, much of which is unstructured, making analysis time-consuming and prone to human error. AI technology enables the extraction of highly valuable and relevant information from unstructured documents, mining key facts, deriving meaning, and presenting the data in a clear, structured manner for data analysts to review.
An example of cutting-edge medical technology combined with AI can be seen at Great Ormond Street Hospital (GOSH), where innovative trials for two rare disorders, Friedreich’s Ataxia and Duchenne Muscular Dystrophy (DMD), are currently underway.
Wearable healthcare technology and AI are used to identify movement patterns and predict disease progression with granular detail. This approach enhances the understanding of disease markers in rare disorders, reducing the need for larger patient pools, which greatly impacts rare diseases with a limited number of affected individuals. With the monitoring technology used in the GOSH study, researchers estimate that 50% fewer trial patients would be needed to achieve meaningful results.
Digital twins in clinical trials
Artificial intelligence (AI) and machine learning (ML) possess the potential to revolutionise clinical research. One ground-breaking application is the creation of digital twins, also known as virtual patients, which can serve as external control arms in clinical trials.
With the capability to generate datasets based on existing information, AI and ML enable realistic simulations of human models. Consequently, studies utilising digital twins offer the prospect of expediting approvals, broadening treatment labels, and accelerating the pace of research in the medical field.
Digital twins could even replace placebos in the future, meaning that all human participants would receive the trial drug, making clinical trials more ethical.
The issue of technology poverty in clinical trials
Incorporating more healthcare technology in clinical trials theoretically opens up participation opportunities for individuals who may have found traditional centralised models inaccessible due to financial strains, time commitments, and barriers to travel.
However, this increased reliance on technology can exacerbate health inequalities and perpetuate technology poverty, where some people have far better access to modern technology than others.
Technology accessibility disparities can arise due to wealth, education, age, culture, geopolitical conditions, and religion. The Digital Poverty Alliance defines technology poverty as “the inability to fully interact with the online world when, where, and how an individual needs to,” revealing that 53% of offline individuals cannot afford an average monthly broadband bill.
Addressing these barriers requires an individualised approach to trial recruitment and mechanics. CROs and sponsors must be aware that prospective participants may vary significantly in their level of technology accessibility and competency. Training and tutorials can help address technology know-how gaps and ensure that the technology used in trials is accessible to all participants. Failure to address technology poverty and consider patient technology know-how can alienate potential participants.
Avoiding widening the gap in socio-economic disadvantaged populations
Research published by the Public Health Wales NHS Trust highlights how technology poverty could worsen health outcomes and widen health inequalities in some communities.
Socio-economically disadvantaged populations are more likely to experience worse health outcomes, and digital exclusion, which disproportionately affects low-income families, rural communities, and older adults, could further exacerbate this divide. Clinical trial designers and sponsors must take these disparities into account and adopt a hybrid model that allows for patient choice and flexibility to avoid widening the gap in socio-economic disadvantaged populations.
Sensitivities and the need for human compassion
Technology in clinical trials should be seen as a tool to strengthen patient-provider relationships, not as a method of avoiding them.
A well-known case involved a doctor delivering a terminal diagnosis to a patient through an impersonal ‘robot’ video link. This incident triggered public outrage due to the lack of compassion and the absence of the human touch when it was most needed.
While technological innovations can be immensely advantageous in healthcare, patients’ needs and experiences must always remain at the forefront of any technological implementation.
Overreliance on technology can lead to burnout in providers and hinder their ability to provide effective care to their patients. New technologies should be integrated into clinical trials to enhance patient engagement and experience without causing a disconnection between the patient and their healthcare provider.
Conclusion
When technology is used to optimise the patient experience, it becomes a powerful tool in healthcare, making clinical trial participation more accessible, equitable, and efficient. However, sponsors and CROs must be cautious not to rely too heavily on technology, as it may compromise the patient experience.
Patient engagement should always be at the forefront of any technological implementation. By actively listening to patients throughout their participation in a trial, we can ensure that data translates into actionable insights that benefit patient care and medical research.
A hybrid approach that combines technology with the human touch is the most promising way to move the clinical trials industry forward, ultimately leading to better patient experiences and improved medical outcomes.
As the industry embraces technological innovations, it must do so with care and a deep commitment to maintaining the patient at the heart of every clinical trial. Only then can we truly harness the full potential of technology to revolutionise the future of clinical trials.
