Paul O’Donohoe, Senior Director, eCOA Product and Science at Medidata, looks at the potential of decentralised clinical trials following the Covid-19 pandemic and how the industry will be affected going forward.
The role that Covid-19 played in advancing decentralised clinical trials (DCTs) cannot be underestimated. Many people, however, wrongly assume that the pandemic spurred the creation of new technologies to make it possible for clinical trials to operate remotely. What it actually did was force the industry to embrace and adopt existing technologies, integrating these into their workflows in the best way possible so that trials could carry on when patients were no longer able to attend in-person visits. This, in turn, opened the door to studies being more flexible and efficient, a trend that will undoubtedly continue.
The best example of the power of the DCT is perhaps Moderna’s Covid-19 vaccine trial. Hundreds of thousands of patients were recruited for this trial in the space of just nine months. It used existing processes, such as allowing patients to document their own data through the internet using their own devices (also known as bring-your-own-device, or BYOD), but on a much bigger scale. When considering the number of people who own a smartphone, and therefore could provide data faster and more frequently, leveraging this process meant that the trial could be carried out in a simpler, faster and more cost-effective way. So, the fast pace of Moderna’s trials were in large part thanks to how clinical trial operators integrated existing scalable technologies into the study design, making it accessible and convenient for patients to get involved. What the Moderna trial teaches us as an industry is that integrating these types of technologies into clinical trials makes trials more accessible to a wider group of patients, thereby improving engagement, recruitment and, ultimately, outcomes.
The role of technology
Three years from the onset of the pandemic and digital technology is now being used more than ever to help decentralise clinical trials. This is making them more accessible, more efficient and more successful. But this doesn’t mean that DCTs are or will become entirely remote. Indeed, decentralised clinical trials are often perceived as having no physical sites and thus no physical interaction with patients, when, in reality, the term ‘“DCT’” typically refers to a hybrid approach to trials, where the traditional structure of physical sites and site visits remain in place, but there is the added choice of ‘a la carte technology’, that increases flexibility and convenience for patients.
Video calls, eConsent and remote monitoring are examples of these existing, established technologies that are improving patients’ clinical trial experience. One of the most established ‘“decentralised’” technologies is Electronic Clinical Outcome Assessment, or eCOA, which uses handheld tablets, home computers or connected devices to allow patients to submit data electronically and remotely throughout the duration of a trial. The integration of technology like eCOA gives a greater number of patients the chance to be involved in trials from which they would have otherwise been excluded, such as those who may not have access to or the means to fund childcare or transport to travel to a trial site.
But the use of this technology is not without its challenges. There will be many patients who don’t have access to it or don’t feel comfortable using devices such as tablets. Trials that are limited to patients with access to a personal smartphone, for instance, might exclude an important cohort. That’s why it is crucial for clinical trial operators to consider this point and strive to create more inclusive and equal opportunities so that people from all walks of life can take part and benefit.
Going back to the Moderna example, this trial overcame some of these issues by using BYOD processes, as well as providing devices to patients who did not have their own or did not want to use their own devices. This demonstrates the very essence of DCTs: the blending of technology with traditional processes through a hybrid model, thus supporting different patients in a range of ways that enables a greater number of people to be involved, regardless of personal circumstance.
How do DCTs affect patient engagement?
Hitting recruitment targets in trials and keeping patients in a study is a constant issue in our industry. That’s because it is often a big ask for patients to commit to trials, especially in instances where trials may be in initial and experimental phases where the risk of involvement may be higher, or if participation involves invasive procedures or lots of travelling.
One of the key benefits of DCTs, and why they are becoming more commonplace, is that they can dramatically improve patient experience, be it through clinicians meeting the patients at their homes rather than requiring them to come in for regular site visits, capturing data at home, or conducting video calls to check-in on trial participants. When trials are designed with patients in mind, it often removes or mitigates factors which previously would have resulted in them abandoning the trial altogether.
And the beauty of a decentralised approach is that patient involvement can be moulded on a case-by-basis: from a weekly check-in video call with a doctor to a highly-involved approach where the patient inputs data every day into a device from home. This flexible, tailored method improves the patient experience, easing the burden, time and stress of taking part in a clinical trial. These patient-centric trials attract a wider range of participants, which boosts the diversity of patient populations, as well as reducing attrition.
Crucially, for DCTs to be successful, patient engagement and patient experience need to be seen as fundamentally intertwined. Thus, when technology is carefully integrated into a study’s design with patient centricity in mind, it can result in more engaged patients, a better quality study, and therefore a higher chance of trial success. This is when you see technologies bringing meaningful benefits to trials.
What is the future of DCTs?
At present, ‘decentralisation’ seems almost a buzz word in the industry. Looking forward, it’s likely that we will move away from being hung up on DCTs and exactly what they should look like. Instead, we will migrate back to talking about just ‘clinical trials’ and assuming that most of these will have greater or lesser elements of decentralisation in them. Those who don’t adopt the DCT approach will be the outliers.
In an industry that seems inherently opposed to flexibility, it is encouraging that the direction of travel seems to be towards accepting and embracing exactly that. Evidence shows us that the introduction of flexibility into our trials doesn’t contaminate the data we’re collecting – quite the opposite, it bolsters and improves it. So, I think we will see this trend continue, as more and more technologies are integrated into these studies. My hope is to eventually see an established, unified and equal experience for all stakeholders, as well as offering a choice to patients, it can only be a positive thing for the future of our industry.