Authored by David MacMurchy, CEO, Lightship
In recent years, we have seen people and technology coming together to deliver advancements in the clinical research enterprise by addressing challenges escalated by the COVID-19 pandemic.
Long-established operating models have been redefined in the wake of the pandemic. The shift towards telemedicine and digital health services has accelerated, improving comfort, convenience, and access for patients, helping to reduce the burden on medical facilities, and giving valuable time back to clinicians and their staff.
Although there is a long way to go in addressing and increasing access and equity in clinical trials, virtual-first and hybrid approaches are driving the progress we need to deliver clinical research today with a three-fold impact.
First, these new models increase access for participants because they remove geographic barriers so people can now be part of a clinical trial regardless of where they live.
Second, participants now have a choice around not just where, but also how they can take part in the clinical trial.
And third, by lowering these other barriers, we are increasing equity in clinical research by making clinical trials available to people across more demographics.
Designing flexibility into clinical trial models that provides choice and improves access is vital in building the clinical trial around the needs of the participant. That versatility ensures that the majority of participants can be met where they are, with maximum access, convenience, safety, and comfort.
Not only does prioritizing choice in clinical trials ease the burden on the participant – it also has the potential to improve recruitment, retention, and diversity in research studies, driving more successful outcomes for all.
The role of ‘the third place’
To optimize choice, we need to have an in-depth understanding of participants’ preferences. When we have spoken to clinical trial participants, the vast majority tell us that they are more likely to take part in a clinical trial if meetings could take place at home or in a mobile research unit (MRU). MRUs have emerged as an alternative site alongside other community-based brick and mortar sites, and outside of traditional settings for clinical studies, like hospitals or medical centers. They provide a ‘third place’ for clinical studies, in addition to a clinic or the home.
Potential participants with annual household incomes below $50,000 per year have been found to be 27% less likely to participate in clinical trials. Having choices on how and where to participate extends the reach of a clinical study across socio-economic boundaries, as well as geographic ones.
Offering alternative visit locations and greater flexibility around appointments reduces the travel costs on the participants and can ease or potentially eliminate work and childcare scheduling conflicts. This can make all the difference, particularly for the most vulnerable, who might otherwise be unable or unwilling to participate in a trial.
The people-first approach
In clinical trials, it is vital to never lose sight of the fact that they are all about people. When we talk about meeting participants ‘where they are’, we are referring to the need to connect with them on an emotional level, as well as a medically focused one. Earning their trust is clearly the most important part of this.
Prioritizing choice can help to reach communities that have a generalized mistrust of doctors and healthcare, with attitudes based on current and historic events. Trust has declined in the last 50 years, resulting in difficult doctor-patient relationships, less patient compliance, and ultimately unrepresentative outcomes. In 1975, 73% of Americans said they had high confidence in medical leadership. According to a Gallup poll in 2018, only 34% felt the same way.
We can help change that by looking for ways to collaborate across the healthcare industry, continuous community engagement and humility to strengthen trust in medical systems. Demonstrating our commitment to transparency about clinical research goals and outcomes is an essential part of this work.
For participants in clinical trials today, there are two things that should be considered. Firstly, it is the opportunity to access a clinical trial they may never have known about or been able to fit into their life.
Secondly, it is that they have the best possible experience while taking part in the study. They need to receive a reliable, caring, people-first experience, and that is dependent on clinical research nurses, study coordinators, and principal investigators; the entire team that works with participants being trained to a high standard.
Participants typically appreciate it when the nurse assigned to care for them is the primary nurse throughout the schedule of assessments, with the frequency of visits dictated by the drug or device protocol. Virtual-first and hybrid models can deliver additional oversight and care that provides a consistently high-level experience. Within these models, smartphone apps play an important role in empowering the participant (and in some cases, their care partners) enabling them to navigate the trial, the scheduling of appointments and clinical trial procedures with greater ease.
Across the clinical research enterprise, we are seeing the results of how prioritizing choice is making it easier to participate in studies. Our experience of virtual-first and hybrid trials has shown increases in recruitment and retention. This can be accomplished by expanding access with targeted recruitment in locations outside a specific geographic radius around a trial site. Mobile nurses are able to go to where the participants are, and not have to rely on recruiting patients solely in close proximity to the site.
The industry is at the start of this journey, but we are already seeing how new models are increasing access, choice, and equity for participants in clinical studies while scaling efficiencies for pharma companies in the conduct of clinical research.
Learn more about Lightship here (https://www.lightship.com/solutions/)
About David MacMurchy
David is a leader in the healthcare sector with over 25 years’ experience working for leading organizations in the life sciences industry. He established Lightship’s people-first approach, which was specifically designed to enhance the experience for participants in clinical trials.
This Opinion Editorial originally appeared in Health Tech World.
 JAMA Oncology, 2016 https://jamanetwork.com/journals/jamaoncology/fullarticle/2457394