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Lisa Bance co-wrote this blog post with Kristyn Feldman.

This post is the first in a four-part series examining patient centricity within R&D.

The concept of patient centricity within drug development is far from novel, yet many pharmaceutical companies still struggle to put the patient at the center of their R&D efforts. In a recent article, we wrote about the need for pharmaceutical companies to become true partners in patients’ health. In fact, our research shows that engaging patients from the outset could lead to improved patient recruitment and retention and reduce R&D costs and timelines. Here’s the first step—one of four—that companies can take to start moving toward patient-centric drug development.

When creating a patient-centric drug development process, companies must first gain an understanding of or empathy for the patient—a step that’s inspired in part by design thinking. Developed and popularized by Stanford University’s Hasso Plattner Institute of Design, and aptly described by Forbes as a “human-centered, prototype-driven process for innovation,” design thinking is a valuable and flexible method for inspiring creative ideas and developing real solutions. A core tenet of design thinking is learning more about your target customer’s experiences. In clinical trials, we believe that it’s essential to gain a deep understanding of both the rational and the emotional factors that affect patients’ trial participation, and to identify the key drivers and barriers that these factors might influence.

Empathy for the patient’s clinical trial experience can be fostered in any number of ways, and many leaders in the industry may already be practicing this first step in some form. Meghan McKenzie, who leads a patient centricity team at Genentech, describes in an interview with Applied Clinical Trials how her team performed a simple walkthrough of a “mock screening visit” for a potential study with a lupus patient. Through this simulated visit experience and a brief interview, her team better understood the patient’s concerns. Subsequently, they modified the single study screening visit into two separate sessions, and reduced the overall number of patient-reported outcomes to ease future patient burden. This type of straightforward but worthwhile exercise can uncover issues not previously considered, and can yield tangible insights for clinical trial teams, like an increase in patient retention and a decrease in the frequency of protocol amendments.

While many industries—including commercial teams within the pharmaceutical industry—embrace the value of direct input from the user or customer, some clinical development teams appear reluctant to speak with potential trial participants, or some teams perceive insurmountable regulatory or legal barriers to directly engaging with patients. However, direct patient feedback certainly is possible, and teams that speak with patients about trial design often describe the input as invaluable. For example, in a case study from the European Patients’ Academy, a major pharmaceutical company provided a synopsis of a rare pediatric disease trial to a patient advocate. The company noted that even just one meeting with the patient advocate led to significant modification of its trial protocol, preemptively resolving issues that could have “prevented parents from enrolling their children into [the trial], or might have caused serious rates of trial drop-outs.” Additionally, this patient insight changed the mindset of the clinical development team regarding the value of meeting patients, who noted that the patient feedback addressed “issues that we should have really thought about, but have not surfaced in discussions both within the team and with investigators.”


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While anecdotal, the volume of examples like these is striking. Time and time again, we’ve heard that once a team or therapy area within a company makes the leap and pioneers some form of direct patient input in their clinical trials, the trend spreads like wildfire. Clinical teams become patient-input evangelists, not only because of the benefits to their trials, but also because they describe meeting real patients as career-changing experiences. Once their colleagues learn about their personal experiences, they want to engage in their own patient input sessions.

But interviews aren’t the only way to gain an understanding of the patient voice. Any number of methods can provide a more expanded appreciation for what patients encounter during diagnosis, treatment or trials, and a few successful tactics that we’ve seen include interactive workshops with patients and caregivers; creating detailed patient journeys documenting the experience from diagnosis through recruitment, trial participation and post-trial completion; patient advisory panels; and market research or focus groups. Successful tactics have one thing in common: Combining some prior knowledge (and, if possible, data-driven hypotheses) with careful listening to glean real-world, personal reactions from actual patients and their caregivers.

Systematically and consistently cultivating empathy for, and an understanding of, the patients participating in drug development is key to creating truly patient-centric trials—and improving the outcomes of trials for both patients and trial sponsors.

Stay tuned for the next part of this blog series, in which we’ll outline the second pillar of patient centricity within R&D.

 

Topics: patient centricity, R&D, clinical trials, clinical trial design, patient empathy, patient voice, patient feedback, drug development, patient centricity in R&D