Published by PharmaTimes September edition 2023
Innovative technology has created high hopes for transforming the landscape of healthcare and improving patient outcomes in clinical trials and long-term treatment.
Yet despite these advances, the delivery and assessment of clinical trial data remain significant and costly challenges, limiting the real-life impact for patients and carers.
Our reliance on static measurements and limited endpoints in clinical trials has become a major bottleneck for progress. Fortunately, if properly harnessed, digital health technologies (DHTs) have the potential to revolutionise patient care and outcomes.
DHTs encompass a wide range of technologies, including wearables, remote health sensors and mobile health applications. These tools enable the continuous monitoring and collection of multiple data points in real time, capturing patients’ everyday activities and routines.
This wealth of data provides researchers with a deeper understanding of treatment efficacy, disease impact and patient quality of life (QOL). By analysing real-time data, researchers can gain insights into how a treatment affects patients in their real-life contexts, beyond that which the controlled clinical trial environment can achieve.
Additionally, DHTs offer the convenience of remote monitoring, allowing patients to participate in trials from the comfort of their own homes, reducing the burden on patients, but more importantly, enabling a comprehensive evaluation of treatment effectiveness in real-world settings.
Trial run
Clinical trial specialists recognise the transformative potential of DHTs. Actigen, for example, is pursuing these technologies to help decentralise clinical trials and overcome the logistical and financial barriers associated with traditional approaches.
In fact, DHTs have already demonstrated their ability to expedite patient recruitment and improve patient engagement in trials. By providing patients with access to DHTs, they become active participants in their own treatment journey, fostering a sense of involvement and empowerment. The improvement that DHTs provide can motivate patients to adhere to treatment protocols, while more closely monitoring their safety, and help to ensure their continued participation in the trial.
This potential of DHTs in clinical trials is now a focus of regulatory authorities. The FDA’s Digital Health Center of Excellence in the USA is actively championing the application of digital innovation in medical product development.
The facility is focused on fostering the development of novel DHTs and exploring their use in improving healthcare outcomes. By supporting and promoting the integration of DHTs in clinical trials, regulatory agencies are signalling their recognition of the value and potential impact of these technologies in advancing patient care.
One of the most significant advantages of DHTs is their potential to offer access to larger sample sizes and real-time insights into disease physiology and expression.
Traditional clinical assessments often rely on limited data collected at fixed points in time, which may not accurately represent a patient’s condition. Factors such as stress, environmental influences and lack of sleep, can significantly impact a patient’s performance during these assessments.
This is especially true for patients suffering from neurocognitive disorders or paediatric patients. In contrast, DHTs enable continuous monitoring and the collection of data in real time – a comprehensive approach that provides clinicians with a rich authentic representation of a patient’s condition and allows them to measure treatment efficacy across a range of QOL parameters.
Rare ground
The Drug Information Association’s Innovative Design Scientific Working Group has presented its perspective on the application of decentralised clinical trials to rare diseases. This approach relies heavily on DHT.
It highlights the potential to improve patient participation and data collection while addressing the specific needs and limitations associated with rare disease research. The authors provide valuable insights to encourage further exploration and implementation of decentralised trial designs (including DHT) in this area of medical research.
A study published in the Journal of Medical Internet Research examined the use of wearable devices in a trial for patients with chronic obstructive pulmonary disease (COPD).
The study found that participants who used wearable devices to track their physical activity and monitor their vital signs experienced better adherence to treatment plans and demonstrated improved lung function compared to those in the control group.
This real-time data provided valuable insights into treatment effectiveness where empowered patients took an active role in managing their condition.
Similarly, in a recent systematic review and meta-analysis that evaluated digital health interventions in type 2 diabetes, DHTs were shown to significantly improve diabetes-related outcomes, including blood glucose control and self-management skills.
Digital health tools were readily adopted by patients, suggesting that digital interventions hold promise as effective and accessible additions to conventional type 2 diabetes management.
This integration of DHTs in clinical trials opens avenues for the collection of real-world evidence (RWE), which complements the traditional randomised controlled trial (RCT) data. RWE provides valuable insights into how treatments perform in real-world settings, considering diverse patient populations, comorbidities and other factors that may influence treatment outcomes.
This additional evidence can inform regulatory decision-making, accelerate the approval of new therapies, and ensure that patients have access to treatments that are safe, effective and tailored to their needs.
Patient promise
Improving patient outcomes by using DHTs in clinical trials also has the potential to reduce the overall cost and timeline of drug development.
Traditional clinical trials often require substantial resources and lengthy recruitment periods, resulting in delays in bringing new treatments to market. By leveraging DHTs, researchers can streamline the data collection process, facilitate remote monitoring and increase patient enrolment.
This not only accelerates the pace of clinical research but also reduces the burden associated with site-based assessments and frequent patient visits; especially true if clinical trials are conducted in countries that do not have a large network of clinics able to conduct trials on site.
Currently, challenges remain in the widespread implementation of DHTs in clinical trials, including the validation of new technologies, which need to be addressed to ensure the reliability and security of the collected data. Barriers to access for older adults with limited technological literacy may also be a limiting factor.
Overcoming these challenges requires collaboration between stakeholders, including researchers, technology developers, regulatory agencies and patient advocacy groups, to establish clear guidelines and standards for the use of DHTs in clinical trials.
With the FDA’s Digital Health Center (and similar organisations) actively advocating DHT use, the future holds promise for enhancing patient care and outcomes through digital innovation in clinical trials. It is essential to harness the power of DHTs to unlock their full potential and accelerate the progress towards improved patient well-being and treatment efficacy.
By embracing digital health technology, we can transform our approach to clinical trials and medicine development, ultimately leading to real-life impact and better healthcare for all.
This has huge implications across rare disease clinical trials, where finding qualified participants, and monitoring their real-world responses, remains one of our greatest challenges.
