Patient Centricity by Design: How Medidata Infuses Patient Voices into the Software Development Life Cycle
The life science industry frequently uses patient centricity as a buzzword, but promoting the idea of patient centricity without action dilutes the term’s meaning and frustrates patients. In a new NEXT Virtual Conference session, Alicia Staley, senior director, patient engagement, explains Medidata’s concrete framework for patient centricity by design, reviews our 2019 accomplishments, and delivers a roadmap for 2020. Since patient input is essential to Medidata’s approach, Staley brings three patient advocates—TJ Sharpe, Liza Bernstein, and Anne Marie Mercurio—into the virtual session for a panel discussion.
In her presentation, Staley shares the fundamental question beneath Medidata’s approach to patient centricity: How do we truly engage patients to develop patient-centric solutions? To answer this question, Staley explains how she and her team started by defining patient centricity. After reviewing over 100 research papers related to patient centricity, they chose the following definition from a 2016 article authored by Guy Yeoman and others: Patient centricity means “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.”
From this definition, Staley and her team established Medidata’s process of patient centricity by design (PCbD). This is the formal process of infusing the patient perspective into the software development life cycle to create technical solutions that improve the overall patient experience in clinical research interactions.
Staley and her team built PCbD around three core principles of patient centricity: design, engagement, and activation.
- Design: Develop and design products and solutions with the patient perspective at the forefront. This requires understanding the patient journey to empathize, the patient perspective to define, patient goals to ideate, patient expectations for prototypes, and patient outcomes for product testing.
- Engagement: Build consistent points of interaction for patients. Medidata hosts consistent events for patients to share their perspective at the beginning of the design process called Patient Design Studios.
- Activation: Enable patients to be active participants in the clinical research process. Medidata established a Patient Design Advisory Board composed of patient advocates, caregivers, leadership team members, and product team members. This group provides governance oversight for the software development life cycle methodology of PCbD.
In 2019, Medidata officially launched the PCbD program, ran two in-person Patient Design Studios with key internal team members, developed and published design principles, and evaluated our software development life cycle process for key points of patient inclusion. In 2020 so far, we held our first virtual Patient Design Studio, and our eConsent product is going through the PCbD review process. This year Medidata also plans to launch the Patient Design Advisory Board, work with patients and sponsors on collaborative design studios for rare disease and oncology, and publish research on our PCbD program in scientific journals.
Staley emphasizes that COVID-19 makes communication with patients more important than ever. During the panel discussion, the three patient advocates echo this point. Anne Marie Mercurio describes the fear among people who need to go into healthcare centers to receive active treatment for early-stage diseases, but she says there’s an opportunity to marry tech with in-person visits to mitigate this fear. She adds that the COVID-19 crisis is an opportunity to change things—she calls upon the industry to carry this sense of urgency beyond COVID-19 to improve patient experiences with technology. Ultimately, “If it doesn’t matter to patients, you’re not doing the right thing,” she says.
For Liza Bernstein, communication with patients is especially important to help reduce the daily uncertainty around trials closing. She wants the industry to find authentic and genuine ways to reach out to patients, and she recommends drawing creative solutions from other industries who have effectively adapted to operating in the COVID-19 era. Bernstein challenges the industry to, “Take into account what people indeed and where they’re coming from culturally in a respectful manner.”
TJ Sharpe shares the mindset of his co-panelists—he wants the industry to stop doing things the way they’ve always been done and evaluate ways to bring trials to patients and deliver the best experiences. He reminds listeners that patients are the end-users of clinical trial solutions, and the best experiences for patients ultimately bring the most value for everyone involved in running clinical trials.
Guy Yeoman, et al., 2016: Defining patient centricity with patients for patients and caregivers: a collaborative endeavour