Incorporating Patient and Caregiver Perspectives

ACT: Why should sponsors prioritize incorporating patient and caregiver perspectives into clinical trial design and conduct?

Birchard: I love this question, because from my perspective, to put it simply, I love backing up and zooming out from that question because I've worked in patient centricity for a while now, and I always want to remind people that it's not a buzzword. It's good that we're shifting our language to be patient-centric and human-centric, and people first—and that is important—but it goes way beyond that. For those of us who work at vendors or sponsors, it's really important that we understand the requirements of patient centricity means zooming out even farther than just inviting patients and caregivers to the table, incorporating them in design of a protocol, it's about the bigger conversations we're having prior to that even happening, like the FDA is having about patient needs and priorities. We really have to first understand what matters to patients, but also create a research ecosystem where it's really inherent in our processes and a systematic change so that we understand that patient input is necessary when we're making decisions about what we prioritize in our companies, in our organizations, because patients and caregivers—and I am a patient, I've lived with chronic illnesses now for 30 years—we have a specific type of invaluable live knowledge that has to shape our priorities as an industry. Again, we have to really create those systems where that engagement is happening early on, and those relationships are happening early on.

When you start with a really patient-centric ecosystem, you avoid a lot of downstream challenges that are seen a lot in clinical trials, like a hard time gathering quality data or recruiting or retaining patients in a clinical trial. If you really talk to patients at the onset of when, before even you're designing protocol or a study, you understand what's actually feasible to patients and caregivers, and you also understand what's important to them.

Actually, I watched the Celine Dion movie a couple days ago, and in it, she was talking about her team, and it wasn't actually related to a clinical trial or her rare illness or anything like that, but she was talking about her team, and she said, “If you want to go fast, go alone, but if you want to go far, go together.” I think it was a really good representation of where we're at with multi-stakeholder engagement in the clinical trial space because we can build a trial, and we can build a protocol really fast, but if we want to do it really effectively, we have to do it together, and we have to do it with patients and caregivers and sites to really do it well.