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We recently hosted a very special event. In place of our usual mdtalk, we facilitated a live round table of experts to discuss the impact of decentralisation in clinical trials.
In this jam-packed, fascinating discussion, representatives from the patient community, sponsors, sites, and clinical operations all sat around the virtual table for the very first time to debate our common challenges:
- The barriers to participation in traditional clinical trials
- Why sites and sponsors might be reluctant to run a decentralised or hybrid trial, and how we can overcome these challenges
- What the future looks like for the clinical trials industry
Host LaQuinta Jernigan, Chief Operating Officer at mdgroup, was joined by:
- Jameka Hill – Senior Director of Clinical Trial Health Equity at Moderna
- Christine Daniels – Cell Biologist at Ask Bio
- Eric South – President of the Gladiator Project
- Megan Liles – Vice President of Clinical Operations at ProKidney Corp
We started our session with one of the biggest questions in the industry: what are the main challenges to getting participants enrolled and keeping them engaged in clinical trials, both site-based and decentralised?
Meeting people where they are – logistically
Eric started our discussion from the patient’s perspective:
“Just having an awareness that a clinical trial even exists for your condition is the first barrier. The point a patient first hears of their diagnosis is a whirlwind of information, with a patient and their family’s primary concern being about what type, intensity, and standard of care they’ll need to cope and live with their prognosis.
“At this point, a patient isn’t even thinking about clinical trial options; it’s all about how they will look after themselves. Yet this is a crucial time for a patient to be thinking about all of their options, clinical trials included.”
The group agreed, and Jameka added: “Sponsors are concerned about the levels of awareness too. The efficacy of the solutions we’re trying to create depends on having a patient community to work with, so having an effective and easy way of getting information out to the relevant patient populations – in formats that are accessible to all – is vital.”
Cost, travel, logistics
Eric said: “From the patient’s perspective, cost is a huge issue. Just getting across a state can be expensive, but having to fly to another part of the country, or even to another continent, and pay for lodging or accommodation is a massive barrier to traditional trial enrolment.”
Christine added: “Travel to site doesn’t just have an immediate impact on participants, and it’s not just the long haul travelling that’s an issue. Committing to a two-three hour round trip once a month at the start of a trial doesn’t feel like too much of an investment, but over time – when we know some trials are for years – and as life starts getting in the way of being able to take what could be effectively a whole day to attend a site visit, that can get pretty wearing.”
The logistics issue is something the industry is still trying to join the dots on. For example, if your trial requires imaging, traditionally, you would travel to the trial site for your appointments. But what if a facility with the same equipment is closer to your home? The group agreed that there should be a middle ground to find appropriate compromises between the data needs of the trial and the reasonable expectations of a patient.
There was a common agreement around the group that, as the industry evolves, the need for faster and more comprehensive regulatory guidance on how to capture data remotely was a vital building block of the next chapter in the clinical trials story.
Not your usual 9 – 5
The group also discussed the accessibility of sites as a barrier to enrolment and retention. It was noted that most sites are open 9am – 5pm, when most participants might be working. It was agreed that ‘after hours’ or flexible opening hours that could accommodate working and child-care hours might encourage more participants to join and stay within a trial.
Access to, and confidence using tech
Jameka raised the issue around confidence in using and accessing technology, including email, mobile phone use, and internet poverty. “It’s an extreme example, but as an illustration, Moderna has been working with the Amish community on how we can best involve them in the clinical trials space. As a business that thrives on technological advancement, it’s a great learning for us. It challenges us in all the best ways to develop accessible communications and foster ongoing relationships with a diverse patient population.”
Meeting people where they are – emotionally
Help patients fight for their lives
A build to awareness is advocacy.
Eric said: ”I don’t think there are enough people advocating patients; supporting them in what could essentially be a fight for their lives. There are a number of online resources, Facebook communities, patient support groups, and charities out there that do what they can with their very limited scope, but they feel disparate and disjointed. How can there be a proactive, positive presence for patients from the moment they’re given a diagnosis?”
It was agreed that there was indeed information available to the patient population who had the wherewithal and resources to research. But there was no central responsibility for the advocacy of patients and clinical trials.
Although it was agreed as a group that many aspects of a decentralised clinical trial (DCT) meet the patient’s needs for flexibility and understanding, Jameka pointed out that we shouldn’t assume DCTs are a silver bullet to all of the traditional trial challenges.
She said: “We have experience of some cultures not actually wanting healthcare professionals (HCPs) to undertake procedures in their homes or places of work and, although it’s harder, travelling to a trial site has for them been preferable. We have to understand that one size does not fit all.”
Quality of life
Eric continued: “From a patient perspective, the time away from family travelling to and participating in a clinical trial is a huge consideration. When you know the trial that you’re enrolled in may not have an efficacious outcome for you, committing to spending some of your precious time apart from your loved ones is a really big deal.”
Indeed, in the case of serious and rare illnesses without a potentially positive outcome, families have to weigh up what’s better for their quality of life: being in a trial or not.
The trial has to work for all
The idea of meeting people where they are has to extend to everyone involved in the trial, including the site and sponsors.
It’s all well and good if implementing DCT methodology ensures better enrolment and higher levels of retention, but are we confident that DCTs are always the right way to ensure data integrity and meet the ultimate trial objectives of a successful test?
From a sponsor perspective, robustness of the data to prove the efficacy of the medication being trialed is a crucial objective. In some cases, this can be compromised using a DCT model.
For example, some samples taken in a participant’s home may have to be left in a fridge for a few days before they can be transported to site. If this fridge is shared, what are the implications for data privacy, or what procedures and assurances does that participant have to make to ensure sample robustness?
Site resource issues
Sites already have very stretched resources, and with the potential added workload of at-home visits, learning how to operate and record data using new tech platforms, and potentially shift working patterns to accommodate after-hours visits, is it any wonder that some sites are resisting wholesale adoption of DCTs?
Sites have to be involved in the conversation and decision-making.
The future is bright – the future is hybrid
The barriers and considerations to enrolment and retention in clinical trials – both traditional and DCTs–- are as varied and personal as the patient population itself, and the group agreed that the only successful future is a hybrid one.
Collaborate to evolve
The best way to achieve this successful evolution is through collaboration.
First, working together to be jointly accountable for the opening chapter in the trial story – awareness – and to establish a collaborative resource or advocacy network that can centralise clinical trial information.
Second, working together to create flexible protocol frameworks. This involves clinical operations teams working with med-tech developers to create platforms that are accessible to all patient populations, connect dots between data and engage the patient in their own progress. sites also need to work together with HCP agencies to relieve the pressure on resources cost-effectively, while maintaining best practice. And clinical operations teams need to map out all local resources for sites, so participants can choose where and when to attend appointments based on their lifestyle, culture, and family circumstances.
Third, and most importantly – let us work together to advocate for patients. It’s not enough to hear their voice; we have to actively listen to what patients are telling us and proactively find solutions for them at a time when they need our support the most.
What do you think the industry needs to do to evolve the clinical trial?
Let’s keep the conversation going.
If you’ve enjoyed our conversation, you can hear more on subjects like this via our podcast mdtalk, available wherever you get your podcasts.