“Patient centricity” is an oft-repeated phrase in the world of clinical research, but not every trial professional agrees on what those two words mean, and how to achieve true patient centricity in their studies. Outsourcing-Pharma connected with Aidan Gannon, head of innovation and client services with Longboat by Advarra, on how to define patient centricity, and ways trial teams can achieve their goals in that area.
OSP: How do you define patient-centricity in clinical research?
AG: We’ve heard the term patient-centricity for years now, but it’s only recently that it’s had a meaningful and tangible impact within clinical trials. Patient-centricity is bringing the voice of the patient into the design and implementation of trials right from the start – ensuring the clinical trial can achieve its objectives and endpoints while creating a positive experience for the patient, their families, and caregivers.
A big component of patient-centricity is thinking about how the overall study, and each individual visit, will impact the lives of the patients and the site staff. This will reduce the inefficiencies that happen at various stages within the trial, from the design of the trial to the way in which the trial’s data is managed.
I think of it as allowing for trials to be done in a way that is less burdensome for participants. As we move away from brick-and-mortar models and move towards decentralization, we need to prioritize the accessibility of trials and make them less burdensome overall.
I’m excited and hopeful for the future of clinical trials. We’re already starting to see really thoughtful approaches to clinical trial designs across therapeutic areas, such as building out a patient’s “day in the life” during the trial, and the introduction of wearables and passive analytics as surrogate endpoints. These elements are really helping drive patient-centricity in clinical trials.
OSP: What are some common missteps trial teams make in designing their studies that might threaten patient centricity?
AG: Flexibility in studies can be difficult to offer and as an industry we need to focus on this more, both from a technology and service provider perspective, as well as on the sponsor side. I think one of the most common pitfalls is that teams don’t recognize that patient-centricity isn’t just about the clinical trial participant but all stakeholders in the trial.
Before a team even begins to design a trial, they should be asking themselves how this will affect the people at the sites running the assessments, the participants, and their caregivers. I’ve always advocated that it’s arguably impossible to be patient-centric without being site-centric.
We have to ensure that trial designs are both operational and take into account the activities that we’re asking of the sites. Fostering strong partnerships with sites and investigators are critical to successful patient-centric trials.
Lastly, one of the recent developments we’ve seen, and is a hallmark of this patient-centricity revolution, is inserting the patient voice into the trial design itself, which I elaborate on further in my next response.
OSP: Why is clinical trial design key in developing trials that are patient-centric at their core?
AG: Clinical trial site design is fundamental in developing trials that are truly patient-centric, and that’s the bottom line. The key is creating a collaborative experience between participants and sponsors. Being a participant in a clinical trial is a huge time commitment and I think in return, we need to commit to supporting them as much as possible along the way.
The need for sponsors to collect data in their trials to support their commercial activities is well understood. As clinical trials get more complex, however, with more visits and more procedures, the downstream effects of such intense visits on patients and site staff should be considered.
There is a strong argument that conducting two shorter, simpler trials rather than one complex trial will not only result in faster overall enrollment and a better experience for the participants but encourage more patients and physicians to participate in clinical research.
A key part of patient-centric trial design is taking a really close look at the schedule of assessments. For example, what are the types of assessments that are being planned and how long are participants going to need to be on-site to have those assessments performed? How many blood draws are going to be done during their participation in the trial? How long is the study?
It’s so important to bring in the voice of many different functional groups within a team - but it’s also equally important to engage the voices of the participants. One way to do this is to work with community groups and advocacy organizations to help inform researchers whether or not they’re creating a study that’s more burdensome for them than it should be. It really boils down to taking a collaborative approach to making sure that studies are as patient-centric as possible.
OSP: How can technology help make treatments more accessible for everyone in an increasingly remote world?
AG: We have a lot of ways that we’re able to use technology today to support the decentralization of clinical trials. One of the most important things to keep in mind is that trials aren’t just patient-centric in terms of whether or not a person should go to a site or conduct trial activities in their home. Instead, we need to have the notion of choice as a part of trial participation. It’s great that we’re able to implement that at an operational level and allow participants to have more choice and flexibility in their trials.
In the next five to 10 years, we’re going to see this a lot more - patients having more control over their experience. For example, not everyone wants to implement wearable technology or do an at-home visit.
Further, some participants may not have access to that type of technology. As an industry, we need to make sure that we have flexibility in our designs to allow for appropriate representation and leverage technology where it’s needed.
OSP: Why are patient-centric trial models essential to promoting diversity and inclusion?
AG: Disparities in healthcare are not new and the pandemic underscored the pressing need to create a more equitable healthcare system. One of the key components to fixing this system is by ensuring that clinical trials are diverse, equitable, and inclusive.
Thinking with a patient-centric mindset allows us to consider that certain demographics are burdened disproportionately by certain illnesses and diseases. We need to be thinking about geographic and socioeconomic barriers, and so much more.
There is no one-size-fits-all clinical trial model, and we need to be constantly innovating to make our studies representative of all people. We will only create the best possible therapies if we are conducting research that is representative of our global population.
OSP: What do we mean by diversity/inclusion?
AG: Breaking down barriers to participation in clinical research has been a long-time priority for the industry. Considering factors such as geographic location, education, and awareness and attitudes around scientific research all play a role in the diversity of a study. That’s why developing a more inclusive and equitable research environment opens so many doors and lays the foundation for future studies across all therapeutic areas.
For example, some ways to promote diverse trial recruitment is through:
- Enhanced communication that meets participants where they are, whether that’s in-person or online
- Trust and transparency into the process and activities of a study
- Increase awareness among under-represented groups through community leaders and role-models
- Effective trial design that addresses the specific needs of the participants and study requirements
OSP: Do you have anything to add?
AG: As a society, I think we need to use the heightened awareness around the COVID-19 vaccine as a starting point to build on clinical trial education. The industry is at a pivotal moment and given the emphasis on decentralization, patient-centricity and diversity must be top of mind for all researchers. The spotlight on clinical trials presents a great opportunity to continue to inform the public and evolve as an industry.