The clinical trials industry is gradually shifting its weight behind decentralised clinical trials (DCTs), seeing the considerable potential to address some of its long-standing challenges, including recruitment and retention of trial participants.
In this report, we explore a perspective often overlooked by the clinical trials industry, that of the participants themselves. Only by listening to, accepting, and understanding first-hand, lived experience and combining it with data and evidence from across the industry can we unlock the future of clinical trials.
As a part of our report research, we spoke to UK-based Fran Cucca about her experience enrolling and participating in a clinical trial in 2022 / 2023.
“I live less than five miles from my trial site, which has made it easy to attend my appointments. My trial team also arranged all trial appointments simultaneously with my chemotherapy each month.
“This meant I had one week a month, which was ‘hospital week,’ making it much easier mentally and emotionally to prepare for it. As a single parent, I could organise childcare for my son after school when I would be at the hospital until late.”
“I was enrolled in this trial by my oncologist and am hugely fortunate that my trial was running at the hospital I was admitted to at this particular moment. It’s a specific trial for people at this exact stage of my type of cancer, and only 300 of us are enrolled worldwide.
“I had previously known that trials existed, but the opportunity to enrol in this trial came when I discovered the severity of my cancer. With all of the emotional upheaval and considerations that come with life-changing medical news, I certainly wouldn’t have had the wherewithal to think outside the box, research a trial opportunity, and find it, if my consultant hadn’t discussed it with me.”
At a time in their lives when people are already dealing with a lot, understanding that enrollment into a clinical trial is a possibility, then finding and effectively evaluating a clinical trial as a treatment option is at best, an inconsistent experience for participants. Access to easy to understand information was a real challenge for Fran.
Fran continues: “I got given this 40-page medical blurb [The Informed Consent document] about the trial that even my oncologist said was the worst thing he’d ever read! I read it from cover to cover, and luckily, I have a degree in sports science and am confident with that type of paper, so I had some understanding of what was going on. But it was very poorly written, made no sense whatsoever, and contradicted itself all over the place. If I had been slightly less determined or picked it up on a day when I felt particularly poorly, it would have been impossible for me to read it.”
Fran was also mindful of being ‘seen’ while undergoing treatment.
“I got to know the two people who run the trial, and I felt like I got more care because I saw the same people each week. Building a rapport with somebody was really helpful. It’s quite intimate the things that they’re asking you, and it made me far more relaxed to be able to get to see the same people each week and be able to open up about all the things that were happening to me. They also come to my appointments with my oncologist to help discuss and sometimes help me understand what was going on with my treatment.”
Normal family life doesn’t just stop; childcare, school, meal times, laundry, arguments about homework, and paying the bills – all carry on around the patient while they are undergoing their trial experience. Navigating these adds practical and emotional strain on what is already a stressful experience.
DCTs can address some of the logistical and geographical challenges of recruitment, engagement, and retention, but not the human challenges.
Although decentralisation is an essential step in the evolution of clinical trials, it is not a destination.
The Future of Decentralisation in Clinical Trials – The Patient Perspective, and what we believe the future needs to be for the clinical trial experience : Read our full report
