The demand for NHS diagnostic services is increasing and so is the prevalence of chronic disease. The right monitoring at the right time in a healthcare pathway can speed up diagnosis and improve outcomes for both patients and family.

It can identify when a patient is no longer responding to treatment or showing signs of relapse; this enables an informed decision to be made for prompt intervention and access to precision treatments. Such early guidance protects patients while reducing unnecessary face-to-face visits, enabling clinical staff to practice more efficiently.

This is crucial during a time when health systems continue to battle both a challenging economic environment and residual pressures of the COVID-19 pandemic. Taking heart failure as an example, the pandemic caused significant disruption to patient monitoring and the ability to undertake routine check-ups.  As a result, efforts to detect disease at an earlier stage have been hindered, leading to later-stage diagnosis and under-treatment of symptoms. This has also caused poor adherence to medication and impaired quality of life, and has been linked to increasing mortality.

Interestingly, the pandemic was also a precipitant to the evolution of monitoring methodologies in clinical trials. We have moved beyond the established industry norms of dependence on in-person review and embraced remote trial monitoring. Telemonitoring and advanced approaches to clinical monitoring are critical components of a more distributed and effective approach to clinical trial implementation. Building the infrastructure and pathways to facilitate these technologies will be a vital component to improving the care for trial patients with chronic diseases.

A prominent example of effective remote monitoring can be found in trials for ATTR cardiac amyloidosis (ATTR-CM). This is a rare cause of heart failure where proteins produced in the liver become misfolded and build-up in the heart, making it a less effective pump to supply blood to the rest of the body. ATTR is a high-risk condition with 60% of patients hospitalised each year following diagnosis, costing the NHS approximately £6,500 per admission. There is currently no licensed treatment to prevent this accumulation of misfolded proteins, with the routine management being to control symptoms with diuretics and careful management of fluids.

‘Telemonitoring can result in substantial time and resource savings, facilitating faster progress to phase 3 studies and ensuring over time that approved medicines reach the patients who need them’

At Richmond Pharmacology, a clinical research organisation specialising in early phase trials, we are currently undertaking studies on patients with both the hereditary and wild-type forms of ATTR-CM. As part of a gold standard of management, these patients are provided with a digital scale and asked to weigh themselves daily. The data is transferred to us in real time via a mobile cellular network, allowing doctors to observe sudden changes in weight, which are frequently a sign of worsening (decompensated) heart failure from ATTR-CM. This allows them to quickly intervene, working with the patient to adjust therapy and control the disease.

In contrast to the cost of hospital admission, a telemonitoring session (including providing a patient with a digital scale) costs approximately £125. This gap in cost can also be observed in clinical trials, where participant monitoring is a major expense, accounting for one-third of the overall cost of clinical trial management.  Apart from the savings, telemonitoring frees up hospital appointments for patients whose issues cannot be monitored remotely. A Cochrane review of telemonitoring in heart failure showed a reduction in both hospitalisation (HR 0.7) and mortality (HR 0.8) in 2015.

Remote monitoring can arm clinicians with the information needed to provide optimal treatments for their patients, as well as making adjustments where a patient shows signs of worsening or relapse. Prior to the use of remote monitoring, in-person follow-up sessions would be required, resulting in slower access to potentially life-saving intervention. Early detection of signals enables faster resolution of issues, and predictive analytics can identify where problems are likely to occur, presenting ways to pre-empt the occurrence of complications.  This can improve quality of life and survival outcomes, particularly for those individuals affected by rare and ultra-rare diseases.

Another key advantage of telemonitoring is its role in driving forward new and developing models of clinical trials, such as decentralised clinical trials (DCTs). DCTs enable the patient to operate flexibly, cutting out repeat travel to the clinical trial site, and equip healthcare professionals to deliver assessments that are local and closer to the community, thus enhancing the patient’s overall experience. The adoption of DCTs and other novel techniques are essential for countries such as the UK to maintain global leadership within the research and development sectors.

Telemonitoring does not just represent a change in process, it requires different skills, new ways of working and training programmes that keep pharmaceutical doctors aligned with the latest practices and trends. The adoption of remote patient monitoring has been slow, with cost and change management being the top two barriers to usage today. Despite innovations in care delivery during the pandemic, some providers and patients continue to be resistant to change.
Clinical leads must be reassured by evidence that telemonitoring is working, hearing from others who use it and have seen the benefits. Moreover, it is important that systems are designed with the input of both doctors and trial participants, placing clinical effectiveness and the reduction of volunteer burden at the centre of trial design.

As we look to the future, telemonitoring can be utilised in advancing models of clinical trials that reduce spending, both in the development of treatments and at point of delivery to a patient. In too many cases, the costs of clinical trial participation are still borne by patients. The implementation of new models can help to reduce this burden. Ultimately, this will not only make medicine development more effective but also serve to widen access to trials, a clear priority to regulators, such as the US Food and Drug Administration (FDA), which recently published new draft guidance for CROs to enrol a more diverse cohort of patients. The FDA said that achieving greater diversity ‘will be a key focus throughout the FDA’ to facilitate the development of better treatments.

Telemonitoring and the wider decentralisation of trials stand to increase productivity in the pharmaceutical industry. More organisations, both privately and publicly funded, need to re-evaluate how they plan and commission clinical research to explore the benefits of using new trial designs across systems and territories.

CROs, such as Richmond Pharmacology, are transforming the way trials are delivered and data is analysed. Telemonitoring can result in substantial time and resource savings for sponsors, facilitating faster progress to phase 3 studies and ensuring over time that approved medicines are reaching the patients who need them.