There are two sides to every story, as they say.
At Patients as Partners in Clinical Research, Joseph Kim spent some time onstage with two patients and two Sponsors in conversation around actionable ways to integrate patient feedback into clinical trials.
In part 1, we shared the juicy details our patient panelists shared around their opportunity to participate in providing input to a Sponsor on a new enterprise trial finder website. It was a treasure trove of wisdom!
Now we’re turning the conversation over to our Sponsor panelists, Michelle Everill and Jessica Perry.
Prefer to kick back and watch the video? View the full session recording.
After breaking the ice by with the unrelated yet obviously important question, “What is your zodiac sign?” Joseph Kim kicked off the conversation around the patient voice in clinical trials.
But what did you do?
Joe: I’ll start with Jess and Michelle to talk a little bit about their experiences in gathering patient insights into a variety of different use cases, covering the big “why” and some of the challenges, different methods that they took, and how they actually turned those insights into action.
Insights are one thing, but what did you do? Obviously if you want to do less procedures, that’s great. But there’s more to that than just saying, “Okay, this is burdensome, let’s do less.” There’s a lot more that can go into gathering patient insights and turning those into action. Any examples you’d like to start off with, when gathering patient insights?
Michelle: I have the privilege of working for a platform company, so the second we see a signal, we jump all over it. We really know that we know nothing, which is an excellent place to be because that opens you up to listening, to investigating what you can do to get that information you’re trying to figure out.
We do a lot with our patient advocacy groups. We do a lot of interviews, we work with them to get more of the qualitative view. We look at real-world data, we look at HR data, we look at different models we could do with our protocol looking at burden scores. But that doesn’t always give you the good stuff. So one thing we’ve been doing a little bit more is simulations where we’re doing interviews with patients. We’re giving them information around the clinical trial protocol, we’re gathering a lot of qualitative insights--there are data pieces where you can get some of these qualitative insights about patients and their journeys as well.
One thing I’ve noticed time and time again is that if you’re talking to an investigator, a clinical trial coordinator, and a patient super early on before your protocol is even completed, you’re hearing a lot of the same things. You’re having to look at the trends and then quantitatively pull that together so that your scientific teams, who are very inquisitive, have something to work with. It really gets to the heart of what’s important to a patient. We think we know what’s important to a patient, like, “Everybody wants home healthcare!” But no, nobody wants anybody in their home.
Every patient has their own fingerprint. They’re all unique and they’re all different. Everybody you talk to will give you something different. The goal and the intent is to go broad and really get to the heart of the DNA of that patient, and then be able to represent them in a way that you’re really affecting change. Using some of these behavioral science mechanisms is how we’ve been able to try to drive and affect that.
The “why”? If you save two hours of a patient’s time on an infusion day, that’s amazing. That makes their day so much better.
Jessica: Kymera Therapeutics is a very early-stage company and I’m particularly excited about the role I’m in now because we’re really starting from the very beginning to be able to think about, “how are we going to be this very science-focused organization and bring that human-centered approach into the clinic and the work that we’re doing?”
We don’t have a whole lot of insights to pull from to be able to look at data and say this is the patient perspective. Really, it's looking at identifying the partnerships, identifying the patients and how we can access them now to be able to gather their perspectives to inform our trial designs.
Time-Cost-Quality Triangle
Joe: What are some of the challenges you see time and time again when you’re trying to gather this information or implement it?
Jessica: The speed-cost-quality triangle. Currently within our operations teams, that’s all we’re thinking about: how to make sure the timing is right and the methods are right to create those actionable insights for our teams. Right now, we’re asking a whole lot of questions and wondering what we are going to learn from patients that we can truly take action on, so that we’re not burdening patients, but actually creating meaningful change.
Michelle: Another challenge I’ll add to that is making sure that it translates. A lot of times what we hear from a patient may not resonate with what a physician is saying or hearing, so I find my job is just translating. I feel like I’m hitting our physicians over the head with different ways of saying something to see what sticks, and then making sure they understand the outcome of that. If we’re reducing the patient burden, then that reduces your time onsite, which reduces your cost, it reduces your resources. You have to turn it into that time-cost-quality triangle. Trying to make sure that the voice and the language is really heard and pulled through is probably the most challenging part. But I feel like we’re making a ton of progress. Our clinicians and our providers are really eager and able to jump on it.
The Brass Tacks of Implementation
Joe: The final question for you, what are some of your go-to methods for actually capturing this information?
Michelle: We do a few different methods. We hold interviews — we want to have a conversation—but a lot of those are blinded, so they don’t know we’re the Sponsor that’s really interested in what they have to say. We always try to do a feedback loop, as well. Whatever comes forward, we make sure that whoever we talk to has an understanding of what came out of the conversation. Some of them are paid, and some of them are not—it depends on who we’re working with and what their process is. We really try to make it easy, attainable, and easy to understand. Now, with all the AI tools, you can do a lot with gen AI to pull out some of those insights that are very impactful.
Jessica: For us, it’s partnering with—there's so many companies out there that can help us with gathering insights and finding the methodologies. Right now, we really need to understand from a global landscape the patient perspective. For one of our trials, we’re doing a phase 2 later this year, and we’ve never been in these countries as an organization. We’re partnering with a group that will allow us to reach and do patient focus groups in each of those countries so we can get all of those perspectives. When you don’t have the in-house infrastructure, it’s finding partners to be able to help you.
The Bottom Line
Like our patient panelists, Michelle and Jessica got to complete the sentence at the end: “Always do this, or never do this.”
Michelle: Always talk to patients. Period. There’s so much information you can gain. Just listening and understanding the patient journey is so critical. Everyone is unique and different, so gathering that information, gathering insights and then being able to translate it is probably the most critical part.
Jessica: I’m sure what I’m going to say is not rocket science, but in the vein of “never do this”: don’t make assumptions. I heard somebody say earlier today that they have physicians in their organization who I’m sure see a lot of patients and feel that they know patients, but at the end of the day when you’re designing a protocol—in particular, when you’re making your decisions on operational execution—you need to have the end users there, and they need to be there to help make those decisions.
Looking for a partner to help you get patient feedback for your own trials? Reach out to us—we'd love to have a conversation.