What is Patient Centricity and Why Does it Matter?
Patient centricity is the concept of designing and executing clinical trials in a manner that accommodates the patients’ perspectives and reduces burden on patients. Patient centricity has rapidly gained momentum within the pharmaceutical industry and has become a regulatory focus in recent years, underscoring its importance for current and future drug development. Over the past decade the FDA has held several dozen patient-focused drug development (PFDD) workshops and developed relationships with patient advocacy groups,¹ and has even released an industry guidance document on PFDD.²
What’s in it for Sponsors?
Besides being the right thing to do, patient centricity offers benefits for study teams, especially in achieving study- and program-level development goals. In one analysis, patient-centric trials were found to take nearly half as much time to recruit patients; additionally, drugs developed through patient-centric trials were more likely to be launched than drugs that were not.³ This means delivering a study ahead of planned timelines (and within budget) and receiving topline results to read outs sooner. Both of which can provide a competitive advantage in registration timelines and product commercialization.
Major Gaps and Solutions in Patient Centricity
Gap: Communication Between Sponsors and Patients
Aside from consent forms, patients are not often provided with additional material or information from the sponsor that was intentionally developed to be patient-facing. Conversely, patients in clinical trials lack a means by which they can share feedback about their individual study experiences directly with study teams.
Solution: Study teams can develop informational material describing the study design, objectives, and treatments that sites can use when recruiting prospective patients. For patients who enroll in a trial, educational materials (eg, videos, newsletters, etc) about study assessments can help patients anticipate what to expect and understand why those data are needed. At the end of the study, all patients should be informed of the study results and thanked for their participation. Patients should also always have a mechanism to share feedback, questions, and concerns directly with the sponsor. Educational materials and two-way communication can ideally be managed through an electronic platform, as this is convenient for patients and allows feedback to reach study teams in real time.
Gap: Visit Schedule and Assessments
Protocols may often require frequent and/or long site visits, a large number of assessments at each visit, or more frequent invasive assessments (eg, biopsies or other sample collection) than might otherwise be required per standard of care. In-person study visits can be very disruptive to patients’ lives, requiring missed time from work, school, or other commitments.
Solution: During the study planning stages, patients can provide valuable input on the quantity and types of visits and assessments that would be acceptable for patients; this information would help the study team to strike a balance between collecting the minimum amount of medically necessary data and still making the study appealing to prospective participants.
Study teams can also explore technology solutions to minimize patient burden. For example, a “Bring Your Own Device” model allows patients to complete study assessments and enter study data (eg, PROs, dosing diaries, etc) directly into their smartphones. Another useful technology solution is to replace in-person study visits with remote telemedicine visits. Both of these approaches are convenient for patients and can help alleviate the burden of study visits.
The Bottom Line
Dedicating the time, budget, and resources to design and implement a patient-centric clinical trial may be a new venture for many study teams, but has the potential to yield tangible benefits for patients and study teams alike. Technology solutions offer an appealing way to communicate more effectively with patients and decrease patient burden.
¹ US Food and Drug Administration. (2017). Enhancing FDA’s Approach to Patient Engagement. Available from: https://www.fda.gov/media/109891/download.
² US Food and Drug Administration. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input – Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. (2018). Available from: https://www.fda.gov/media/113653/download.
³ The Economist Intelligence Unit. (2018). The Innovation Imperative – The Future of Drug Development, Part I: Research Methods and Findings.