Patient centricity is more than an industry catch phrase. It is the future of all health research and therapeutic care.
We are on a clear path towards value-based health care and patients are at the heart of their current treatments and future health outcomes. Seeking both scientific expertise and incorporating patient outcome research is becoming a critical element in the success of current and future treatments.
This, however, was not commonplace in the pharmaceutical industry 25 – 30 years ago. Few self-reported measures were developed and large-scale studies informing the patients’ perspective were scarce. Additionally, the health-related quality of life (HRQL) end-point was misused and abused and no regulation was in place.
To address these issues, four organizations/societies produced supporting guidance documents in 1999 on the use of HRQL evaluation in drug development: the ERIQA Group, the International Society for Quality of Life Research (ISOQOL), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and the Health Outcomes Committee of PhRMA (PhRMA HOC).
In 2000 a series of meetings (called HRQL Harmonization meetings) involving the above organisations took place to compare all recommendations and explore the points of controversy, and the scope was broadened to the notion of patient-reported outcomes (PROs). These meetings were instrumental in the development and publication of the FDA guidance on the use of PRO measures in drug development to support labelling claims.
Since 2000, further regulatory efforts have been implemented in the USA and Europe to include the patients’ perspective into drug development and regulatory decision-making.
Table 1: Regulatory Efforts (2000-2022)