By Alicia C. Staley
A 2017 BMJ Innovations journal article defines patient centricity as “Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family.”
Although the journal Applied Clinical Trials started reporting on patient centricity in 2014, there is still no universally accepted definition of a patient-centric trial and no standardized way to determine whether a protocol design is optimal for patients. Lacking those tools, many sponsors struggle to design and conduct studies that accommodate the perspectives and preferences of patients and caregivers.
Companies often capture patients’ insights for a specific trial by convening an advisory board, conducting feedback sessions, launching a marketing campaign, and employing patient-facing technologies such as digital health and mobile apps. While these techniques can be helpful, they don’t represent an integrated or systematic approach. Sponsors are left to balance the preferences and priorities of patients and caregivers with those of the sponsor team, including medical directors and statisticians, and site personnel like investigators and study coordinators while meeting scientific and regulatory requirements. But these occasional sessions often lack follow-up and preclude consistent relationships, so patients rarely hear whether, how, or why their feedback is being used, which can erode trust in the process and make future collaborations less likely.
At Medidata, we wanted a gold-standard methodology to embed patient centricity into the software we build to run clinical research. We call our process Patient Centricity by Design (PCbD), a spin on the concept of privacy by design (PbD) developed by IT pioneer Ann Cavoukian.