The latest trends in clinical trials, like decentralization and AI, can help make a trial more efficient, effective and successful. But what if the patients at the center of the trial don’t like the new approaches?
Look out across the landscape of clinical trials and you’ll see systems going digital, processes becoming automated, and AI and machine learning coming to the fore. But as trial design and implementation shift towards more decentralized approaches, it’s important to keep the participants in mind. What does the digitalization of clinical research mean for them?
Decentralization grew as a necessity in response to the pandemic, but it has proven to be advantageous to clinical trials. Benefits include cost and time savings, flexibility and patient centricity. Similarly, researchers say AI could help improve patients’ experiences during clinical trials.
Since the most common reason for stopping a trial early is low accrual rate, enrolling and retaining participants is a major concern for any clinical trial. A new survey of trial participants reminds us how important it is to include participants’ views when considering new options for clinical trials.
The survey of 1,129 people in the USA, conducted by Velocity Clinical Research, suggests many participants are not in favor of one of the features of many decentralized trials: home visits.
Home visits: a building block of decentralized trials
Decentralization has brought together many elements previously thought to help improve enrollment and retention, including home visits. Research conducted a decade ago suggested home visits would help encourage more people to take part in clinical research, as they would remove the barrier of having to visit a clinical setting.
But the new survey results suggest this element of decentralization may not be the simple solution it seemed. Perhaps surprisingly, most respondents said they would prefer to go to a clinic than have an appointment at home or via telehealth. Overall, 76 percent of patients would prefer to attend a clinic, and in particular, 82 percent of women under 25 and 79 percent of women over 65 said they would rather attend a clinic.
There is a major implication for diversity in clinical trials here too: no black female respondents chose ‘home visit’ as their preferred appointment type. Considering how vital it is to improve representation, it will be important to take participants’ preferences into account when designing and implementing clinical trials.
Velocity concluded: “Home visits are not the most suitable strategy for increasing diversity in clinical research. Instead, trial design must focus on a hybrid solution, such as extending operating hours of sites and using more telehealth options.”
What’s the alternative?
The good news is that decentralization can work with various options, including a hybrid approach that incorporates virtual and in-person visits. In the Velocity survey, respondents said they were generally happy to consider using technology in future trials.
Specifically, the survey included four approaches that respondents supported:
- E-diaries – 82 percent
- Telehealth visits – 78 percent
- Wearables and home monitoring devices – 75 percent
- At-home collection of bio-samples – 64 percent
However, the support varied according to age. For example, although 90 percent of women aged 55-64 said they would opt for telehealth visits, only 45 percent of women aged 18-24 said the same. Similarly, just one in three 18-24-year-olds said they would feel comfortable collecting bio samples remotely, compared to 75 percent of those aged 34-65.
Design with the participants in mind
The results suggest that while most respondents are ready and willing to work with technological solutions when they participate in a clinical trial, many – particularly younger people – have some hesitation. It will be vital for those who design user interfaces for wearables, devices for bio sampling and telehealth systems to have patients’ needs top of mind.
The more we use technology in healthcare more broadly, the more familiar patients will be with these approaches. In the meantime, we must consider patients when thinking about the best approaches to take with clinical trials. Although this is only one small survey, it highlights the importance of considering patients’ needs beyond any assumptions that may exist.
Here are some questions you could consider asking:
- Who are the target participants? Think about their age, gender and experience with healthcare and technology.
- How would they prefer to interact with clinicians? If possible, ask them before setting plans in stone.
- What methods of interaction would work best for your trial setup, and is there crossover with patient preferences?
- Could you consider a hybrid approach? A mix of telehealth and in-person visits could be ideal.
Putting patients at the center of your trial can help you succeed from enrollment to endpoint. At Siron Clinical, we have expertise spanning many trial types and therapeutic areas. Contact us to find out how we can support your research.