Interview: Lessons learned during Covid and what the future holds for hybrid and decentralised trials
OSP: Many areas of our lives were heavily impacted by the Covid pandemic, office work being just one of them. What have we learnt from the pandemic in respect to of clinical trials?
While there are certain properties of a clinical trial that remain immutable and fundamental, such as respect for individuals and data integrity, what is deemed ‘best practice’ develops over time as methodologies and technologies evolve. This is particularly true in a post-pandemic world, where clinical trial teams are attempting to take the technology-driven learnings adopted during the crisis and combining them with pre-pandemic practices. The result has been a sharp rise in the number of so-called hybrid trials taking place, where the traditional structure of centralised, in-person clinical trials is deployed in conjunction with virtual, or decentralised elements, in a way that is tailored to specific study designs and the individual patient. Technological advancements in recent years have helped make hybrid trials a reality by allowing clinical data to be recorded and analysed accurately and efficiently in remote settings. In practice, this means that patients taking part in hybrid trials can choose whether to submit trial data through software installed on a mobile phone, wearable sensor, via a video call or at a local clinic, rather than having to make regular visits to a trial site.
OSP: So what are some of the technologies being used in DCTs?
The industry has been hugely successful in implementing hybrid practices in recent years thanks, in part, to its willingness to combine multiple technologies into a single trial. One of the most established examples of this type of technology is eCOA, or Electronic Clinical Outcome Assessment, which enables clinical trial data to be documented and tracked through questionnaires filled out on a range of devices, including personal mobiles and tablets. This technology means that patients don’t have to battle with multiple, new or unfamiliar devices, instead inputting data wherever they are, simply using their own devices.
eCOA has become the mainstream method of capturing key endpoint data in pivotal trials in recent years and trial designers have integrated it alongside other powerful technologies, including eConsent, telemedicine, sensors, and wearables, taking decentralisation to a whole new level.
The Moderna Covid vaccine trial is a shining example of a trial designed to integrate different types to technology. The study team allowed patients to input data into their own personal devices, while also providing devices to those who required them. This was by necessity of course, given the restrictions and limitations imposed by the pandemic on travel and personal contact, but it proved that such a trial could not only work, but work extremely well on a massive scale. The other advantage to this sort of trial design was that it was centred around patients, adapting to their lives, rather than the other way around.
OSP: It has always been hard to recruit and keep people on trials, how can using technology and hybrid trials address this issue?
Patient recruitment and retention are essential for a trial to succeed. Many trial operators, however, find that patients are unwilling to take part in trials or drop out of trials that involve invasive or long procedures or lengthy travelling which involves taking time off from work or arranging childcare. Hybrid trials, which incorporate technology, help to address these problems because they are designed to ease this burden and put patients’ needs first. The flexibility and convenience they offer is more attractive than conventional trials and can significantly boost retention rates. Meaningfully embracing ‘patient centricity’ should not be underestimated. Better engaged patients results in higher quality studies which, in turn, increases the chances of a successful trial outcome.
Take this example: the average trial participant spends on average two hours travelling to a test site each time they need to attend. That is a considerable burden and so it should not come as a surprise that for a proportion of patients this sort of travel requirement becomes too much. What’s more, when multiplied by the thousands of people involved in a trial at any given time, cutting down on this travel time has the added benefit of being better for the environment.
Another benefit to patient centricity is that it increases trial diversity. Technology enables patients to be involved in a trial who might otherwise not have been able to, such as those with childcare responsibilities or limitations on their ability to travel, such as affordability or mobility. The whole point of running a clinical trial is to ensure that an effective, safe drug reaches those who need it. So, ensuring a trial reflects the actual patient population as much as possible – rather than just those whose circumstances allow them to take part – will improve the quality of the data that is recorded, lead to better insights on how a drug works and, ultimately, better trial outcomes.
OSP: What do you think the future holds?
The lessons we learned during the Covid pandemic around how to incorporate technology into clinical trials and the subsequent advancements made with hybrid trials are playing a crucial role in supporting more accessible, more diverse trials, designed with the patient in mind. Many trial sponsors have accepted that hybrid trials can be run successfully, hailing them as the “new norm”, with decentralised practices now firmly embedded into trial processes. But it’s rare for this industry to remain static for long. The question now is, how can we advance and improve clinical trials even further? Well, we still have a lot to learn about how we can use the technologies we have at our disposal, and there will doubtless be more innovations over the next few years offering even more possibilities to improve clinical trials for the benefit of patients. What is required of us as an industry is to retain that pandemic-era mentality, remaining ready and willing to embrace new ideas and ways of working.