How Boehringer Ingelheim’s Site Engagement Academy Is Helping to Create Empathetic Site Partnerships for Patient Benefit
Boehringer Ingelheim created an internal training program for their site-facing staff to better understand and anticipate the challenges facing their clinical trial sites. Patient and Site Engagement Lead, Wouter Daniëls, tells us about the Site Engagement Academy, what it has uncovered for sponsor staff, and how it is impacting their site relationships for the better.
What led to Boehringer Ingelheim creating the Site Engagement Academy?
Of course for Boehringer, our ultimate goal is to be the preferred partner for sites and patients. It started off actually with the creation of a new job role at Boehringer. The clinical trial manager position went from very operational – project management, submissions, writing informed consents, etc – to relationship building and engagement with sites as we began to outsource more of the operational talks.
Because relationship building requires such a different set of skills, I felt very strongly that we needed to set people up for success by training them. From my own past experience working in clinical operations I felt there was a big gap in training for communications and relationship-building, in the clinical research setting. The need for training ultimately led to the creation of the Site Engagement Academy.
"We are not partnering, and that’s the change we need to make. It means that sponsors need to put more time and effort into sites, to be more proactive, to invest more money."
Tell us more about the training.
The training consisted of two in-person modules. The first was communication and site relationship building. The second was all about site empathy. Besides presenting the site perspective we also set-up a panel of actual site representatives. We wanted to put our staff in the shoes of sites and explore their motivations, barriers, needs etc. The panel consisted of 4-5 people from different sites and different backgrounds, who presented and then did Q&A with the audience.
We did a pilot at a meeting for a large Phase III program. The pilot was very well received, and we got the approval to do this in every region where Boehringer is present, which ended up being a world tour consisting of 11 meetings.
In each location, the BI local teams organized their meetings, including a panel consisting of and reflecting the regional site staff. We also gave guidance that each panel member had to have experience and good knowledge of the operational aspects of trials. We didn’t want to hear from investigators who accept the trial but aren’t doing the actual work. We wanted to build site empathy, and make it localized to the region.
How did BI staff respond to the training?
The feedback has been extremely positive. On average, we had a net promoter score of 64, which is huge, based on 500+ responses globally. It still amazes me because it’s not rocket science, but apparently it’s not something that has really been done before.
One of the positive side effects was that the site staff members who were invited to be on the panels became so enthusiastic as well, and remarked on how much they learned from the sponsor perspective.
"For the whole industry, we need to make sure that we get a better understanding of clinical trial participation, both on the site and patient level. We need to invest in the relationship with our sites and make sure we work with them as true partners."
What has changed as a result of the training?
In one of the regions, the site staff was very vocal to the BI staff: “Please come and see us. We are happy to show you around, show you how we are working, and show you what we are facing when we’re doing clinical trials.” I spoke to the Head of Clinical Operations later, and he said, “We’re going to change that instantly. We’re going to go out to the site much more often than what we are doing right now.” The team had been living under the impression that sites didn’t want to have sponsor staff visiting them, and that meeting totally changed their perspectives. As a result, they are visiting the sites much more often to speak face-to-face, versus over the phone or virtually.
In another region, they have now created site personas. They work with sites with different operating models, from big academic sites to small commercial sites, and wanted to capture the different motivations and pain points of each site type. They first created profiles based on their own assumptions, and then created profiles based on 100+ interviews with site staff. They overlaid each set of profiles to see what they had gotten right, and what they hadn’t. These activities bring abstract concepts and theories to life,and turn them into daily practice.
What did you learn from attending all of these site meetings?
Many things were familiar to me from my past experience, but to give one example, I learned about the reality of site finances, particularly smaller commercial sites. Our payment schedule is not aligned with the reality of site revenue and spend. We pay every few months, based on data entered into the CRF, so it can take a long time before sites are paid for a visit they have conducted. If you then learn that these sites only have enough revenue to cover for the next six months, you start to understand their difficulties.
Knowing that helps to anticipate. If you’re working with a smaller site, and you know they basically rely on income from each visit, you can be proactive in your contract negotiations and payment frequency. That’s a small action with big consequences for them. If we can gather these insights and make those types of changes, sites will be better equipped. We all benefit from that.
Are there any other big problems for sites that you want to surface?
Technology. We are throwing too many tech solutions at our sites, and that’s something we’re trying to get under our control. Sites are overburdened and patients are annoyed. We need to make sure that the technology we are implementing actually works and actually solves a problem.
Do you think the academy achieved its goal?
The larger goal is to change the culture within the organization and shift from “putting out fires” to “preventing fires from starting.” That change is cultural, and takes long within a large organization. We are planting seeds and showing BI staff, “This is what’s happening on the other end of the table when you’re trying to execute trials.” We wanted to encourage them to look at activities from the site perspective in order to anticipate what barriers they might have and what support they might need, to prevent things from happening or going wrong.
"We are planting seeds and showing BI staff, “This is what’s happening on the other end of the table when you’re trying to execute trials."
What does the Site Engagement Academy indicate about the larger relationship between sites and sponsors?
I think it shows that we have underestimated the importance of sites in the equation. We obviously, for good reasons, have focused on patient centricity, but in the pursuit of that, we almost forgot about the sites. But as I tell people, our way to the patient in our clinical trials is through the site. Because of that, we need to balance the interests of the sites with the interests of the sponsor/CRO and the patients. If we focus too much on the patient, we end up with protocols where the patients are happy, but sites are struggling.
We have to make sure that our trials are as easy to conduct as possible, because a happy site means a happy patient. They should be focused on building their relationships with patients and ensuring a positive experience, because that’s beneficial to all of us. If that is taken care of, recruitment goes faster, retention gets higher, the data is of higher quality and the treatments we bring to market are better grounded by data on effectiveness and safety.
We have treated sites like vendors. “You promised me five patients. Where are my five patients?” We are not partnering, and that’s the change we need to make. It means that sponsors need to put more time and effort into sites, to be more proactive, to invest more money. But it will pay off in the end if you have a good relationship with your site and a protocol that is easy for them to conduct.
Why is this so important to publicize and for other companies to do?
For the whole industry, we need to make sure that we get a better understanding of clinical trial participation, both on the site and patient level. We need to invest in the relationship with our sites and make sure we work with them as true partners. There are too many trials going on and too few sites, so we need to cherish the sites that are already working with us and find ways to attract new ones. Too many sites try a clinical trial once and will never do it again (one-and-done) because of the bad experience we give them. If we can change that as an industry, everyone benefits, but it can’t be done by one company alone.
