Giving Voice to Patients

The patient engagement network allows patients to share real life stories and experiences about what benefits participants expect to gain from a trial . . .

Patients are at the center of everything we do, including having a voice in how our clinical trials are designed and carried out thanks to the company’s unique Patient Engagement Network (PEN) initiative.

The goal of a clinical trial is to determine if a treatment is safe and effective. In the past, trials were designed to answer the scientific and medical questions, and may have had patients in mind, but did not include their input or advice.

That’s changed at Bristol-Myers Squibb.

“The PEN allows patients to share real life stories and experiences about what benefits participants expect to gain from a trial as well as the challenges they have in participating in trials,” says Lori Abrams, head of Diversity & Patient Engagement in the Clinical Development organization. “That, in turn, helps us design a much more patient-friendly trial.”

Lori cites the work in developing a clinical trial for people with Sjögren’s Syndrome as an example of the importance of getting patient insights. Sjögren’s is an autoimmune disease that affects the entire body, resulting in complications that include chronic pain and profound fatigue.

To ensure the patient perspective was included in the trial design, the Diversity & Patient Engagement team put together a Sjögren’s Patient Engagement Network (PEN) that included not just Sjögren’s patients, but also study coordinators, caregivers and members of the Sjögren’s Syndrome Foundation, an advocacy organization. The members of the PEN shared the challenges they would face with a traditional trial design.

“One of the first things that became obvious was how the crushing fatigue and chronic pain suffered by many afflicted with Sjögren’s would be a real barrier for participation in a traditional trial that involved regular travel to a clinical site. We would be asking people to do something they may not be physically able to do,” Lori says. “It was clear that having people travel to a clinical site would be a burden to them.”

Another barrier to participation was the number of invasive procedures called for in the initial trial protocol, which included lip biopsies and blood samples.

“We talked to our clinical staff and it turns out some of the procedures were ‘nice to have’ rather than absolutely necessary,” Lori says. “So the number and frequency of invasive procedures could be significantly reduced without affecting the integrity of the trial.”

In the final trial plan, the requirement for regular travel to a clinical site was reduced by having nurses conduct home visits whenever possible and providing a car service for participants when necessary – concierge service as Lori calls it.

“The Sjögren’s PEN gave us insights that we couldn’t have gotten any other way,” Lori says. “Those insights helped us design a clinical trial that will gather the information we need while just as importantly, meeting the needs of the participants.”