How Boehringer Ingelheim Incorporates Patient Feedback in Trial Design

What is the work you’re leading at Boehringer Ingelheim?

I work in a center of excellence in the US organization focused on advancing patient engagement and our patient-centric culture. My role is primarily focused on patient engagement – which we define as the bidirectional interaction between the organization and our patient stakeholders to inform the design of our products and services. I work at a macro level across the company, optimizing our process and innovating the ways in which we engage with patients, as well as tracking and reporting on the patient engagement activities that the US is engaged in to our US human leadership teams.

"If we want to develop products and services that meet patient unmet needs, then we absolutely have to be collecting and actioning patient insights early, often and throughout."

How has the patient-centric culture at Boehringer Ingelheim specifically in tracking and applying patient-generated learning, evolved?

Our approach to measuring and reporting has evolved with the behavior that we’re trying to encourage. Initially, it was an activity-based metric: reporting to our US leadership team, “This is the frequency of patient engagement activities that were planned, and that had been completed.” The reason for that is because our leadership recognized the importance of patient engagement and wanted to encourage teams to adopt it more broadly.

They wanted to know the progress on that and if we were improving. But as patient engagement became more common and more teams were embracing it and doing it organically, we recognized that we needed to evolve and move beyond an activity-based metric.

And so we now capture additional information about the activities: What was the method used to collect the insights? What was the impact of the activity? On an annual basis, I do a qualitative analysis to understand what methods teams are using and how the insights are informing our decisions.

The behavior we’re trying to influence here is to encourage teams to use those insights in their decision-making, because our company believes that if we want to develop products and services that meet patient unmet needs, then we absolutely have to be collecting and actioning patient insights early, often and throughout.

How are you determining success in these activities?

We really look at success primarily based on two things: first, did the patient stakeholder(s) that participated in the engagement have a positive experience, and second, did the team consider those insights in their decision making? That’s not necessarily, “Did something that a patient said in the engagement result in a change?” Because if you’re doing patient engagement right and you’re considering patient perspectives from the beginning, you might not be changing anything. Because you’re hearing what they need, and you’re making decisions based on those insights.

It does mean, however, “Has the team talked about it and have they considered those insights in their decision-making?” Because what we have found is that sometimes insights are available too late, or even if those insights are available, they sat within one group, but they weren’t a part of the team discussion when they were actually making design decisions. Those are barriers that we’re trying to understand better, to then look at our processes and make sure that we’re solving for these challenges.

How are you engaging with patients?

We engage with patients in many different ways, at varying levels of engagement. At the most basic level, we have one-way patient insights: doing focus groups or interviews, even surveys, to understand specific unmet needs, preferences around outcomes, key symptoms and impacts, etc.

And then as you move up that ladder, you have higher levels of engagement. There is an advisory level, co-creation, and all the way up to being involved in patient stakeholder-led initiatives, where Boehringer Ingelheim is in a participatory role. All these different levels of engagement have a place.

How do you communicate the value of patient engagement activities back to the organization?

Because patient centricity is one of our guiding principles, I do think that value is understood. But how did we get here?

It’s really been a combination of factors. Part of it is more and more teams experiencing it for themselves. When you actually are involved in an engagement, you might go into that a little bit skeptical and think of it as a “checking the box”, but you’re going to come out of that exercise recognizing how important it is and understanding the value of gaining insights.

A big part of it is having funding resources, leadership support, and expectations that we will do this and having teams experience it for themselves.

But the other piece of it is also equally investing in the organizational culture. Within the US Center of Excellence, we also focus on supporting a patient centric culture. So no matter where you sit in the organization you know, you have a patient-first mentality. One example is our patient ambassador programs, where people are nominated within their different functions and are trained on patient centricity and given resources that they can bring back into their teams.

Think of Starbucks: they start every meeting with a coffee tasting where the employees learn about where those beans are from. It’s just a part of how they start their meetings. We do it similarly: we have something called “patient minutes,” brief stories from or about patients that anchor the team in the conversation about what we’re trying to accomplish here.

Sometimes patient minutes are from someone from a therapeutic area team sharing the results of a patient engagement activity. “This is what we learned and this is how the team is using it.” Sometimes it is content pulled from the public domain.

For example, patients talking about the importance of diversity in clinical trials. Sometimes they are patients sharing their experiences living with a disease in a therapeutic area we are working in. It’s important for us to really understand the disease areas that we’re working in, from that patient lens.

"We need to be looking – within the United States – at the disease population, the prevalence and unique cultural differences and social determinants of health that impact the design of our trials or the way in which patients access and experience our products and services."

Can you share an example of an outcome resulting from specific patient engagement activities?

This is an example that’s not tied to a specific insight, but about a way in which the team approached patient engagement systematically. We were working in a new indication for Boehringer Ingelheim. In preparation for the start of development– before we were even in humans – the Global Patient Advocacy team organized the first global patient advisory board meeting.

And in that meeting, one of the patient organizations presented results from a survey that really helped characterize the key symptoms and impacts and they described some of the challenges with existing clinical trial measures as they don’t align with the key symptoms and impacts from the patient perspective. And so because they were having that conversation so early, the clinical trial team was able to work with the patient community to include endpoints in our first clinical trial that were meaningful to patients. That’s co-creation.

What do you envision patient engagement in pharma looking like in 3-5 years?

I’d like to see it be systematic and seamless; it has to be built into the very way in which we approach everything we do across the lifecycle of medicines.

We’re certainly making great strides here at Boehringer Ingelheim in that area; many pharma companies are. Not any one pharma company does it all best, many shine in one area. Some excel in patient engagement in commercial, others in clinical development. But until we have patient engagement and patient insights seamlessly and systematically integrated throughout our process, we won’t truly be doing patient-focused drug development.

In terms of next steps: pharma has been doing a better job at getting patient input, but the next focus is going to be on representation in the insights that we’re gathering. It can’t be only with patient organizations that have a select patient population. We also need to be looking – within the United States – at the disease population, the prevalence and unique cultural differences and social determinants of health that impact the design of our trials or the way in which patients access and experience our products and services.

The same way that we’ve pulled in patient insights into our development approach, we need to also be pulling into these considerations very early and ensure that we’re getting representative input. It’s exciting to be a part of work that is rapidly advancing the science of patient input.

For more information on Patients as Partners, visit patientsaspartnersconference.com. To listen to Dr Wilson speak about operationalizing patient insights from research to commercialization, click here.