Working up front with patients—starting in the research space to identify unmet medical opportunities according to patient need—and then extending patient interactions into the construction of clinical trials and patient-engagement approaches has helped Sanofi optimize the way they approach clinical trials. Patient input has aided the company in terms of reducing the number of subject visits, increasing overall patient satisfaction levels, and generally improving its clinical trial research programs, says Victoria DiBiaso, Sanofi’s global head of clinical operations strategy and collaboration.
“We’ve seen a dramatic reduction in amendments along with other significant improvements,” DiBiaso says. While these positive results aren’t all due to adopting the patient-centric approach, it’s clear it is a big factor, she adds.
Perhaps most importantly, the patient-centric approach, if more widely adopted in the industry, can improve the perception of clinical trials, DiBiaso says. “It will help people understand that research is good, and that patient collaboration is needed in order to provide new medical options to patients faster and more efficiently,” she explains.
Sanofi works closely with patient groups to identify patient advisors, and engages with them from the early research stages into when the investigational medicines advance into human studies. In the clinical space, this means working with patient groups and members of their patient communities before trials are designed.
The interactions are not intended to be about recruitment; instead, Sanofi views the patient advisors as subject matter experts. In turn, the company uses input from patients to inform the early design of a trial and its subsequent patient outreach based on that input, so the studies are designed around the day-to-day lives of patients and the information and support associated with the trial meets their needs.
For a recent trial in a young population, Sanofi’s early patient engagement quickly told trial managers that the best way to interact with subjects was via social media.
“One participant told us ‘I spend 95% of my time on social media and the other 5% charging my phone so I can get back on social media,’”DiBiaso says. “That tells us that electronic collection of patient-reported data and activities to support adolescents for retention is appropriate for this patient population.”
In another study, Sanofi was looking at how best to allow patients to reduce their overall site visit burden, which would require more study medication to be managed at home in a refrigerated setting. The patient advisors worked with Sanofi on the solution of providing participants with refrigerated cooler bags so that the medication could be removed from the large packaging and fit into their fridges, and letting them bring materials back to the site on a less burdensome schedule. “It was such an easy solution that we might not have thought of it ourselves,” DiBiaso notes. Sanofi reduced the cost of the study and the site visit burden, and maintained high levels of patient retention by providing that kind of flexibility, she reports.
There are other intangible benefits, DiBiaso says, noting that members of a patient group took the microphone at a recent DIA show to say how much they enjoyed working with Sanofi and its patient-centric approach to designing trials. “That felt pretty good,” she says.
Learn more about implementation of patient centricity, social media, and mobile technology in clinical trials from these recorded ACRP 2016 Meeting & Expo sessions: