Presentation (CTI)

OBJECTIVES: Caregivers are increasingly recognized as important stakeholders in the development and evaluation of medical products, as highlighted in the FDA's PFDD Guidance 3. While caregiver experiences have traditionally been assessed through the concept of burden, increasing attention is being paid to the broader impact of caregiving on physical, emotional, social, and economic well-being. This study aimed to characterize trends in the development of caregiver burden- and impact-clinical outcome assessments (COAs).
METHODS: The PROQOLID database and published literature were reviewed to identify COAs assessing caregiver burden and the impact of caregiving. COAs were analyzed according to year of development, therapeutic area, and target population age category.
RESULTS: A total of 114 caregiver-focused COAs were identified, including 108 from PROQOLID and 6 from the literature review. The number of COAs increased over time, doubling approximately every decade, from 6 COAs developed between 1980-1989 to 12 between 1990-1999, 21 between 2000-2009, and 45 between 2010-2019. Seventeen additional COAs were identified between 2020 and 2025. Caregiver assessment has also become increasingly disease-specific, with 24 disease-specific versus 15 non-disease-specific COAs identified between 2005 and 2014, and 25 versus 8, respectively, between 2015 and 2025. Among disease-specific COAs, the most represented therapeutic areas were central nervous system disorders (27%), neoplasms (15%), and mental disorders (11%). Most COAs targeted caregivers of adults (n=81), while fewer were developed for pediatric caregiving contexts (n=33).
CONCLUSIONS: The sustained increase of caregiver-focused COAs reflects increasing recognition of caregiver experience as an important outcome in health research. The growing emphasis on disease-specific COA development indicates a more nuanced approach to assessing caregiving experiences across conditions, particularly in neurological and mental health disorders, therapeutic areas that have historically led the development of COAs. Continued development of caregiver-focused measures across additional therapeutic areas and pediatric populations may help generate more comprehensive evidence to inform healthcare decision-making.