Patient centricity aims to prioritize the patient perspective in the development of medical treatments. The concept of patient-focused drug development (PFDD) is now a priority for drug developers following the U.S. Food and Drug Administration’s (FDA) release of PFDD guidance documents as mandated by the 21st Century Cures Act enacted in 2016. Although this information is available, evidence of implementation is lacking. Therefore, the aim of this research is to explore the extent of PFDD implementation in drug development using a qualitative case-control study design.
The PFDD guidance documents were used to develop the coding framework. Deductive qualitative content analysis was then performed on the review packages for three drug products- Neulasta, Cosela, and Jesduvroq, FDA approved in 2002, 2021, and 2023 respectively. Neulasta was selected as the control case. Cosela and Jesduvroq were selected as the experimental cases. A total of 21 documents for Neulasta, Cosela, and Jesduvroq were included in the analysis. Following the first round of auto-coding, eight of the 21 documents contained codes. These eight documents were then reviewed in their entirety and coded manually.
