Over the past few years, the digitalisation of clinical trials has taken centre stage in clinical research. Accelerated by the rise of decentralised clinical trials (DCTs) during the Covid-19 pandemic, sponsors, and contract research organisations (CROs) are now taking a more deliberate approach to using digital platforms and solutions.
We know that DCTs can improve the participant experience by bringing research closer to their homes and by utilising technology like wearables, remote patient monitoring (RPM), and web-based eConsent. Alongside other procedures, including sending medications and supplies directly to participants’ homes, and providing in-home nursing care, DCTs can now support studies which require physiological data points, and can even decrease geographical bias.
GlobalData’s exclusive DCT Tracker: tracing industry’s adoption of decentralised clinical trials [i] shows that although adoption has slowed following the pandemic, 296 trials initiated during 2022 utilised digital data collection, compared to an average of just 20 per year between 2010 and 2016.
While recruitment of participants onto DCTs can be achieved using a range of digital technologies and other measures, keeping these patients enrolled on a study protocol has its own unique set of challenges.
Differential dropout
Key amongst them is dropout (attrition) during a clinical trial. This can sometimes have the effect of causing bias within the trial if differing dropout rates between treatment arms or participant demographics occur. Randomised controlled trials frequently experience dropout, which can jeopardise findings because those who remain may differ from those who withdraw their participation.
According to an analysis of 71 randomised controlled trials published in four prestigious medical journals, dropout rates of 20% or more were recorded in 18% of the trials.[ii]
Additionally, participants in clinical trials can benefit from access to new or newly optimised therapeutics, but this requires ongoing participation in the trial, especially if the investigational therapeutic is not currently available on the market.
Three ways to keep your participants engaged
With all this in mind, it is vital, both for sponsors and patients, that participants stay engaged all the way through to the end of their study. We know that factors causing drop-out are similar to those that have an impact on accrual, and while some dropouts, such as a participant moving abroad or their condition suddenly deteriorating, may be unavoidable, many are due to lack of experience with technology, cultural differences, or issues surrounding costs.
“What we find in terms of participants engaging with research and sticking with it, comes down to their motivation,” says Dr Arrash Yassaee, a paediatric doctor and Global Clinical Director for Evidence Generation and Information Governance, at Huma Therapeutics. Huma is a global digital health company that powers at-home virtual care, DCTs and digital companion apps.
“From my experience, the single most important thing is that the goal of the research is engaging and meaningful to that participant group,” says Dr Yassaee.
Below, we have identified three ways of adding valuable engagement with your participants during your study trial. Each draws on lessons learnt in the last few years and features some of the latest thinking in clinical trial designs based around the use of technology and RPM.
1. Telemedicine and multiple touch points
By using site-to-participant messaging, researchers can communicate the latest trial information and protocol changes quickly and easily. Other messaging, such as daily check-in support, application alerts and notifications, can encourage engagement and act as timely reminders for taking medication or updating a digital dashboard.
Telemedicine appointments or ‘televisits’ also facilitate seamless communication through direct contact with clinicians.
Huma’s user-centric digital app encourages data entry and usage with a reported 99.7% of participants in a recent study group[iii] saying that they found the Huma app ‘useful.’ Featuring an intuitive, easy-to-use participant dashboard, Huma even provides a ‘web lite’ version that enables data entry without a smartphone.
Dr Yassaee says that using a digital platform to collect data remotely allows participants to contribute more frequently without the inconvenience and expense of having to travel across the city: “It’s not just a time issue. In many cases it can be disruptive for all sorts of reasons. For example, in paediatric research, it’s disruptive to parents who have to take time off work, and for a child to come out of school.”
2. Carers and proxies
Some participants can have issues around technology. Some mobile devices may be too old to work with newer apps. The participant may be tech hesitant or may even worry that expensive equipment will get lost or stolen.
Offering ‘patient concierge support services’ is one method to get around technological problems. This service effectively assists the participant by guiding them through the clinical trial and offering assistance with device setup and operation.
This works well where participants are trained to use a particular device with which to monitor their own health care, explains Dr Yassaee: “For example, blood glucose, where participants will be checking it several times a day, or blood pressure where participants are trained to check their vitals several times a week.”
Sponsors can also use a proxy option if the participant is hesitant to use technology or has mobility issues that make using devices such as keypads difficult. This feature enables a designated person, such as a friend, relative, or caregiver, to create a profile and submit the required information on the participant’s behalf.
This is especially important, for instance, in paediatrics, or when participation is especially demanding for patients. By reducing or even suppressing the need for frequent in-person visits, digitally enabled trials can reduce the burden on those enrolled by making participation more feasible for those who have difficulty travelling or taking time off work.
For example, chronic diseases or conditions that can severely affect mobility or the capacity to visit a site can be a strong barrier to enrolment and retention. In this respect, digital technology can help ensure a better user-centric experience and focus on inclusivity, allowing population groups to participate from their own homes or local healthcare facilities.
3. Educational content
When patients come up against something unexpected, such as side-effects, educational provision via an app or platform can give instant reassurance. With participant resources and information, educational modules can assist participants to better understand their medical condition and even increase involvement.
The Huma ‘Learn’ module, for example, helps participants understand what to expect from their trial with educational explainers, FAQs, and disease education, along with dietary guidance and more. The Learn module also regularly publishes any updated trial guidance.
Building confidence is an important consideration in supporting participants in both their condition and ongoing plan of care.
The good news
Over the last ten years, there has been a steady decline in the percentage of studies that stop prematurely. According to exclusive analysis by GlobalData, the termination rate for clinical trials has decreased from 10.6% in 2010 to 4.7% in 2021.
Digital components are increasingly being included in studies, which according to GlobalData analysts, may be contributing to this trend.[iv]
Dr Yassaee points out that any tool that makes the patient experience more enjoyable or can encourage and engage study participants is an advantage: “It can become easier for the participant and a much more pleasant experience.”
To learn more about how digitalisation is transforming clinical trials, download the whitepaper below.
[i] https://www.clinicaltrialsarena.com/analysis/dct-adoption-tracker-who-and-what-is-at-the-crest-of-the-trial-decentralisation-wave/
[ii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4688419/
[iii] https://academic.oup.com/ofid/article/9/4/ofac063/6524243
[iv] https://www.clinicaltrialsarena.com/features/clinical-trial-terminations/