Non-traditional barriers to participation in pharmacologic chronic kidney disease clinical trials.

BACKGROUND

The Agenda for Sustainable Development agenda prioritizes access to care for non-communicable diseases, including chronic kidney disease (CKD), and sustainable cities and communities. City-level health may impact local research capacity and subsequent participation in randomized controlled trials (RCTs). We identified city-level barriers to CKD RCT participation in the cities from the Global Observatory of Healthy and Sustainable Cities (GOHSC).

METHODS

We conducted a cross-sectional study of 214 drug CKD RCTs (2003–2023) with participants spanning 146 GOHSC sites. We queried open datasets to retrieve relevant financial, urban, healthcare, and nephrology-related indicators. We designed a CKD research capacity scale incorporating six variables: population-weighted RCTs, sites per sqkm, funding, site span, facility type, RCTs per site. We classified research capacity as absent (0–1 points), insufficient (2–4), fair (6–7), good (7–8), or excellent (9–10) and compared indicators between research capacity categories.

RESULTS

Of the included cities, Odense had the highest population-weighted RCT count (7.01 RCTs per 100,000 population), and Mexico City had the lowest (0.06 RCTs per 100,000 population). Cities with good or excellent research capacity had higher health expenditures, nephrologists, and dialysis centers per million population than cities with absent or insufficient research capacity. In cities with good or excellent research capacity, the most prevalent type of insurance coverage for CKD was public, whereas mixed financing was the most frequent type in cities with absent or insufficient research capacity. Among the identified non-traditional barriers to CKD RCT participation, daily living score, access to public transport, access to open spaces, and access to a fresh food market were higher in cities with good or excellent research capacity, compared to those with lower research capacity scores.

CONCLUSIONS

We found differences in CKD research capacity across the cities included in the GOHSC Study Collaboration, which may be affected by financial, socio-demographic, healthcare, and nephrology-related barriers. Local, regional, and international initiatives should address distinctive local variations to enhance CKD research capacity. CLINICAL TRIAL NUMBER: Not applicable