Ryan Bailey, MA is a Senior Clinical Researcher at Rho. He has over 10 years of experience conducting multicenter asthma research studies, including theInner City Asthma Consortium (ICAC) and the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) project.
In the previous post, we explored the rationale behind patient centricity and acknowledged the danger we face if we fail to pay heed to the rising tide of patient dissatisfaction with our trials. In this post, we focus on the more positive and practical aspects of patient centricity, and how a patient-centered approach can improve our work and reduce our costs.
To start, I think it helps to step back and consider why we do what we do. We are in the business of healing people, of eradicating painful, debilitating, life-taking diseases, and of giving people hope. How do we do that?
We rely entirely on the willing and voluntary participation of patients – the real heroes of clinical research. When patients are in our trials, they put their body on the line, they give their time, they attend visits, they're poked and prodded, and they share blood and tissue and data with us so we can help heal others. We have an ethical and moral imperative to do right by them.
When it comes to ethical protections and patient safety and well-being, we have a number of invaluable guidances that steer our work – the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, Good Clinical Practice, to name a few. Unfortunately, our familiarity and history working with these seminal documents can sometimes lead to the misleading notion that we've "solved the patient rights stuff."
However, we cannot be content to rest on our laurels. We need to consider what lies ahead. What is next on the continuum of evolving ethical milestones that define our work? I believe patient centricity is a key aspect. With patient centricity efforts, we are called to move past our historical approach of saying “we want to do this for patients" to saying “we want to do this with patients." We change our traditional paradigm of “patient as a participant” to “patient as a partner” in the research space. We invite patients to contribute their voice to what we're doing, to help us figure out what matters to them, and then we do it.
Of course, this leads to an inevitable question – how do we do that? Answering the “how” question can seem daunting, especially given the apparent novelty of patient centricity as a movement. A common impulse is to feel like this is “yet another” set of tasks to burden research teams. Fortunately, “patient centricity” while relatively new as a term, is not new in concept.
Patient centricity is in our DNA as researchers. Yes, this is an "emerging trend,” but it didn't come out of nowhere. It's a natural extension of a variety of disciplines and movements we care about – things like adherence, retention, patient advocacy, patient rights, patient-reported outcomes – all of which laid the groundwork for this. Patient centricity isn’t so much a new trend, as it is a culmination of many different efforts that have been pushing us for years to better accommodate the needs and desires of the patients in our trials.
For example, we already know that patient engagement efforts lead to better recruitment and retention because research on these efforts shows the benefit of understanding and accommodating patient needs. Likewise, research shows that engaged patients have better adherence and better health outcomes.
There are, rightfully, concerns about adding costs and time to our processes; but the good news is that the investments of patient centricity can prevent many of the “unforeseen” costs that commonly handicap our studies: delayed or insufficient recruitment, high dropout, and poor participant adherence. What's even better is that research coming out of DIA and the Tufts Center for the Study of Drug Development (available to download here) shows that many of the simplest, most affordable, and lowest time-commitment investments promise some of the best returns. They found that simple things like involving patient advocacy groups and patient advisory groups in study planning and development, and engaging patients on social media, can have some of the highest impact.
Consider also that patient centricity is a virtuous cycle. Once you learn what works for a particular group of patients, you can build on that for future research and gain efficiency over time. Likewise, as research sites and study teams develop reputations for good patient engagement, patients will be more likely to participate in future studies and advocate on your behalf to others in their social groups.
Patient centricity is still evolving as a movement, and you can expect to hear a lot on this topic in the years to come. For now, the question is one of when to act. Patient empowerment is happening in healthcare and patient dissatisfaction threatens our industry. If you’ve experienced the pains of not being patient centric, through slow or stalled recruitment, poor retention, weak adherence, or disappointing patient-reported outcomes, taking a wait-and-see approach is a risky endeavor. On the other hand, if you are motivated to adapt to the changing patient population, value continuous improvement, and want to see better return on investment, patient engagement is a good place to start.
To get you started, I propose a new acronym (because we don’t have enough in our industry as it is).
AIR – Ask, Inform, Respect
It’s pretty straightforward, but you would be surprised what keeping these principles in mind can do for your relationship with your patients. To start, ask patients what matters to them and how we can better design trials to meet their needs, and listen to what they say. Then, make an effort to keep patients as informed as you can throughout the project without threatening study integrity. Ultimately, respect the patients. Every one of us is going to be patient at some point in our life. We're only extending to them the same respect and empathy we would hope to get if we were sick, in pain, and anxiously hoping to find a cure that would improve our lives.