How digital platforms provide a bigger picture for patients in clinical trials

Paul O’Donohoe, scientific lead, eCOA and Mobile Health at Medidata explores how using digital platforms and remote solutions can give the broadest picture of patient response.

Patient burden – a continuous hurdle

Patient burden in clinical trials remains one of the biggest challenges for the life sciences industry to address. Patient retention and adherence are crucial in the clinical trial process and can dramatically impact the outcome of the trial. Dropout rates are sometimes over 30%, leading to trial delay, additional costs, risk to the validity of the study, and potential failure of the trial. By lessening the burden on trial participants and ensuring they are engaged in the study, dropout rates can be significantly reduced, and patients can generally have a more positive experience. It’s therefore essential that trials are designed with patient centricity at top of mind.

The concept of patient centricity is not new and has been a topic of much discussion in the life sciences industry over the last decade. During this time, we’ve seen the industry begin to engage with patients during the protocol development of a trial. This has had a truly meaningful impact on how studies are designed and conducted, as it gives patients an opportunity to voice what is realistic, viable and important to them. Alongside this, we are also starting to see technologies emerge as key tools in improving the patient experience. While cutting-edge technologies have always been used in clinical trials, the industry is beginning to embrace the potential impact these can have on reducing patient burden and, in turn, delivering the best quality data and broadest picture of patient response to a new drug or treatment.

We repeatedly hear from patients that the most frustrating aspects of clinical trials are the day-to-day burdens - time spent on-site, cost of travel, days off work, stress of finding childcare and the list goes on. The negative impact these significant burdens have on patients' ability to remain engaged with trials are well known and has been a key driver towards using remote tools that move engagement away from physical trial sites and into patients’ homes. Patients can now complete questionnaires and surveys at home or do physiological tests in their living room or at their local GP/pharmacy, thus providing greater flexibility to patients.

Tools being deployed to maximise adherence

Electronic clinical outcome assessments (eCOA) are to date the most commonly used digital tools to provide insight into the patient experience in a clinical trial and have become the mainstream method for capturing this kind of data in pivotal trials. These measures (usually in the form of questionnaires) are designed to explore how a patient is feeling or functioning and are used to provide better insight into how patients are responding to a treatment. Having historically been captured on paper, this electronic shift has brought significant benefits in regard to data quality, as well as simplifying the whole experience for patients and clinicians.

Another tool that is growing in prevalence is the use of electronic informed consent, or eConsent. Consent forms have traditionally been full of dense language more focused on providing legal protection, rather than to truly educate patients with the information they need before joining a trial. Today, rather than being a box-ticking exercise, eConsent engages and educates patients on the clinical trial they’re about to join. It uses interactive components like video, infographics, and audio components, as well as the ability to look up definitions and flag up areas of uncertainty. This gives patients the opportunity to be truly informed on what they are signing up for, and by receiving consent forms electronically they can review and deliberate at home with their families before proceeding. The process builds trust and means that patients who may have been concerned by the jargon now feel comfortable with the trial and the process. And by allowing patients to electronically sign their consent, they can be recruited and on boarded onto a trial remotely and far more quickly.

Wearable devices, ranging from medical grade sensors to commercial wearables like Fitbit, are also  attracting intense interest in the clinical research space. These devices hold the promise of providing an additional datastream alongside the more established eCOA measures to provide a deeper insight into the patient experience. It also opens the possibility of performing assessments which might traditionally have needed to be completed at a site under the supervision of a clinician in the patient’s own home (e.g. the 6-minute walk test). We are only just starting these conversations and the next step for wearables will be to determine what the data is really telling us and how it can translate into something meaningful for the trial. Once we are able to determine the full potential of these technologies, the patients may not even have to think about doing specific tests – the data will be captured automatically in real-time.

Flexibility by design and what’s to come

One of the key strengths of these technologies is that they can be scaled up and down to meet the needs of a specific study and patient population. At Medidata, we call this the ‘Trial Dial’ - the amount of trial virtualisation can be easily adapted to meet the specific needs of the study. For example, in an oncology study where patients are often receiving a significant amount of additional treatment support, it may make sense to do more on-site activity so the patients can be monitored carefully and receive the care they need. But in a trial looking at a rare disease, where patients are scarce and likely located far from the trial site, it may make sense to use remote solutions to improve access and remove geographical restrictions.

While some digital technologies, such as eCOA, are already in widespread use, the adoption of some digital and remote solutions still face headwinds. Wearables are still new, some clinicians favour traditional methods and, most significantly, regulators tend to have a conservative and careful approach when adopting new technologies. This is why educating the industry on these tools and demonstrating their true value is imperative.

The Covid-19 pandemic has significantly accelerated the industries' reckoning with these tools. We saw clinical trial sites shut down overnight and study teams were suddenly unable to capture the stream of data needed for their trials. Regulators advised companies and investigators not to be afraid to harness the power of technology to keep trials moving. The industry saw an increased interest and uptick in digital platforms and remote tools to allow trials to continue virtually.

The increased use of digital and remote solutions is certain to persist beyond the pandemic. By normalising these patient-centric technologies and increasing patient engagement, clinical trials will obtain better, broader and more complete data, ultimately leading to better outcomes.