Welcome to episode eight of mdtalk. Through this podcast and video series, we’re on a mission to highlight the most important issues impacting clinical research, the patient experience and the future of healthcare.
Listen to the episode here or search for mdtalk wherever you get your podcasts.
This episode focuses on disparity in clinical trial participation between patient populations, industry innovations to improve health equity, the accelerated movement towards decentralised trials – and what all this means for patient accessibility, diversity and engagement.
Our host LaQuinta Jernigan, Chief Operating Officer at mdgroup, speaks with Adam Samson, Head of Clinical Delivery Operations, RWE Clinical Trials at Walgreens, to understand the importance of trial design for health equity.
Adam is an expert at conducting clinical trials across multiple therapeutic areas as a coordinator, monitor, project manager, and executive within academia, sites, CROs, pharma, tech, and retail pharmacy. He currently serves as Head of Clinical Delivery Operations at Walgreens where his primary role is to operationalise existing locations to conduct clinical trials.
Adam also serves as adjunct faculty at The George Washington University in the Master’s in Clinical Research Administration program, as well as serving as a core member in the Decentralized Trials & Research Alliance (DTRA) working group to map the participant journey in decentralised clinical trials.
Episode overview
The episode begins with LaQuinta sharing a reminder of why clinical trial diversity is such an important topic. Despite the fact that drugs react differently to different ethic groups, only 11% of triallists are Hispanic or Latinx and fewer than 10% are Black and Asian.
LaQuinta and Adam discuss these statistics and Adam sets out how Walgreens plans to leverage its existing trust within local communities to make a real difference to inequality and access to trial participation.
Delivering accessible community healthcare
Adam explores Walgreens’ long history of community engagement, made possible by its 9,000 stores located across the US. In fact, roughly 78% of the US population live within five miles of a Walgreens store. The chain has also made strategic efforts to be in harder to reach places and under-served communities. Just over 50% of stores, for example, are in socially vulnerable areas.
Adam details how it’s on this foundation that Walgreens Health has been built over the past year. New services, including the opening of a number of ‘health corner’ locations within suitable stores has brought new dimensions to community healthcare. These ‘health corners’ are staffed by registered nurses and pharmacists, and boast private health rooms for chronic care management.
Furthermore, Adam explains, Walgreens stores can also be set up to offer other types of point of care diagnostics. The advantages to this regarding clinical trials is clear – Walgreens offers a ready infrastructure that reaches into almost every community in the US. By partnering with pharmaceutical and medical device companies, Walgreens is able to offer access to much broader population groups to achieve the diversity representation goals of clinical trials.
Overcoming barriers to clinical trial participation
LaQuinta agrees that logistical challenges play a large part in whether participants will enrol on a clinical trial. This is especially true for those living in rural areas or without the means to travel, which may thereby unwittingly exclude certain demographics.
Trust is a second key barrier. LaQuinta explains how in some communities, potential participants are discouraged from taking part in clinical trials because of a mistrust of “outsiders” and unknown clinical trial staff.
She reasons the Walgreens approach could help rebuild that trust because staff members are already a part of the local community. Adam agrees that pharmacists are the trusted providers people are accustomed to seeing every day. He also references a 2013 CES study which demonstrates the effectiveness of having pharmacists deliver basic clinical research education. Adam notes this grassroots approach means that retail pharmacies are not just being told about clinical trials, they are becoming part of them.
Whilst shoppers are picking up their daily prescriptions, they get to know their pharmacy team. Being able to visit that same pharmacist to participate in a clinical trial makes the taking part much more familiar and trusted.
Leveraging technology to improve patient diversity
LaQuinta highlights how alongside building trust, emerging technologies also play a huge part in improving patient diversity.
Adam agrees that technology has come on rapidly, even in the last 10 years, but has been accelerated due to the pandemic. Now, it’s possible to conduct trials via telemedicine, take consent digitally, and monitor and track patients remotely more than ever before. As a result, many people who previously did not have access to clinical trials, are now being actively encouraged to enrol.
At Walgreens, the plan is to leverage emerging technologies as part of its core clinical strategy. Even from a logistical perspective, moving online has many benefits, including eradicating the need to keep centrally available paper records and requiring patients to travel to them. Now, with a centralised team being mobilised, Walgreens are planning to make trial access easier for all, and to ensure the quality and consistency across the network of sites.
Adam concludes that new technology is really helping to give both the pharmaceutical medical device sponsors, as well as large companies like Walgreens, a vote of confidence that this can be done. And this can be done in a way that is highly compliant.
The role of data in decentralised clinical trials
Data is the cornerstone of decentralised clinical trials, and managing how it is used is a major focus for trial designers and CROs, as well as retailers such as Walgreens.
Adam explains how using data, Walgreens are not only able to engage with potential research participants within its network to determine interest in clinical trials, but can also aggregate data generally to provide meaningful insights.
Instead of simply picking a number of sites and then investigating whether the population fits the trial requirement, using the data and insights from Walgreens can mean a much more targeted approach. For example, it can be used to identify specific patients who fit tightly defined trial protocols. Not only does this reduce the recruitment time, it also means that trial participation might be higher. Adam says:
“We are laying the foundation of how we can use the information that we have available in a very meaningful and thoughtful way to drive where best to bring our clinical trials and how best to offer those clinical trials to our consumers”.
Moving closer towards clinical trial equality
LaQuinta poses the key question: when will community outreach programmes and engagement initiatives really start to positively impact trial diversity?
Adam responds by highlighting markers of progress, including the FDA draft guidance around clinical trial diversity earlier this year. Adam notes that due to the nature of clinical trials, it can take time to see lasting change. Despite this, Adam says:
“I’m quite optimistic that in one to two years, there will be real change in the way that we’re conducting these studies, or the way that we’re designing our recruitment plans, to make sure that we’re hitting those diversity metrics”.
The role of the pandemic and the Black Lives Matter movement in accelerating decentralised clinical trials and the diversity conversation
Adam and LaQuinta discuss the role these two recent seismic events may have played in the advancement of decentralised trials.
Adam agress the Black Lives Matter movement shone a bright light on many inequalities, including health, and where industries need to improve across the board. Added to that, the pandemic also highlighted the critical importance of clinical trials and how technology can be leveraged to keep them going, even when hospitals are closed.
However, Adam reasons that calling these trials ”decentralised” is missing the point:
“We still need large academic medical centres, physicians and healthcare practices to participate. We can’t do everything virtually and we shouldn’t rely 100% on technology. That’s not a way to build trust and increase health equity”.
“Equity is about more than just a quality, it’s about making sure that everybody has access at the level that makes sense for them based on their needs. So I think the intelligent use of technology is really how we’re going to get there”
Adam goes on to explain how he favours a hybrid approach, where retailers such as Walgreens are supporting the medical centres and healthcare providers by providing the community link.
DTRA
mdgroup is a member of the Decentralised Trials and Research Alliance (DTRA), so in conclusion LaQuinta asks Adam to talk through his association with the DTRA and the organisation’s aims and objectives.
Adam explains he joined the DTRA sub-committee a year ago, and was part of the core team to define what the initiatives and deliverables should be around decentralised clinical trials best practice. The committee brought together the entire trial ecosystem for a collaboration session. Adam’s details how his particular focus has been on reducing complexity of the customer journey to identify those areas where people might become disinterested or not know where to go, and then to find ways to mitigate those problems. The results will then be publicly shared, as Adam says:
“We’ll make those publicly available and then provide the templates so that others if they so wish can use that to take their clinical trial and map out the participant journey, and use that as a tool for improving patient access, retention and other things around clinical trials”.
LaQuinta agrees that in order to make any strides in solving the challenge of diversity and clinical trials and accessibility, that the clinical trial industry needs to come together and collaborate, exactly as the DTRA is doing.
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