The clinical trials industry is gradually shifting its weight behind Decentralised Clinical Trials, seeing the considerable potential to address some of its long-standing challenges, including recruitment, engagement, 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 the clinical trial.
As a part of our report research, we spoke to US-based Chris Ojeda, whose 11-year-old son, Billy, is taking part in trials for a rare muscular condition. We spoke to Chris about his family’s considerable experiences navigating the trial landscape and the challenges they have faced.
Chris and his family have been involved in clinical trials since 2017.
For the first trial, Chris and Billy would travel between California to Florida every few days for three months. Over the course of the last six years, Billy has lived in hotels approximately 50% of the time. The impact on the rest of the family is huge. The other two children miss their father when he is away with Billy, and all of the day-to-day childcare responsibilities fall onto Chris’s wife while they are away.
Chris told us, “On our next trip, we will have been on 200 airplanes and travelled the equivalent of 14 times around the earth in six years, participating in trials. The burden of the travelling, on top of the physical and emotional toll of just being enrolled in clinical research, is exhausting.”
Being diagnosed, or having a close family member diagnosed, with any illness, let alone a rare disease is a stressful and difficult process.
At this time, people are already dealing with a lot, and therefore finding and effectively evaluating a clinical trial as a treatment option is challenging. Adding to the anxiety at an already challenging time is the lack of easy access to information.
Chris tells us: “I would say the biggest hurdle was knowing where to begin. In my experience, our doctors didn’t know anything about clinical research or trials that could positively affect the life expectancy of [my son] Billy. Our experience, and that of every parent with a child with a rare disease I’ve spoken to, is that figuring everything out about clinical trials falls squarely on the shoulders of the parents.”
After getting in touch with patient and parent support groups for Billy’s condition, who pointed them in the right direction, it was very much down to Chris and the family to research what clinical trials Billy qualified for, where they were, and how to apply.
The agony of decision-making has also been a considerable burden for Chris and his family, with the very first decision being whether to take part in a trial at all. Billy suffers from a devastating terminal muscle-wasting disease that affects all the muscles in the body. He’s only 11 years old, and there is no agreement on his life expectancy.
Chris told us: “Some parents would say the amount of time spent in clinical trials will take away from spending time with their child, so they might choose to skip the trial and live in the moment. Then other parents say, I’m going to fight till the last breath. We decided to be the latter, so we chose to research our options and try to enroll in trials.”
But once steps are taken to enroll and participate in clinical trials, sometimes the burden on patients and their families increases.
Chris tells us: “Even the mundane things like ensuring Billy gets his homework done while undergoing trial therapies is a challenge. The pressure on my wife, who misses her son and husband while running the family home for weeks, is crushing.”
Normal family life doesn’t just stop; work, the daily commute, 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 as a parent of a trial participant or a parent enrolled in a trial 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 evolving 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, here: Read our full report
