Global capacity for clinical research in nephrology: a survey by the International Society of Nephrology

Abstract

Due to the worldwide rising prevalence of chronic kidney disease (CKD), there is a need to develop strategies through well-designed clinical studies to guide decision making and improve delivery of care to CKD patients. A cross-sectional survey was conducted based on the International Society of Nephrology Global Kidney Health Atlas data. For this study, the survey assessed the capacity of various countries and world regions in participating in and conducting kidney research. Availability of national funding for clinical trials was low (27%, n = 31), with the lowest figures obtained from Africa (7%, n = 2) and South Asia (0%), whereas high-income countries in North America and Europe had the highest participation in clinical trials. Overall, formal training to conduct clinical trials was inadequate for physicians (46%, n = 53) and even lower for nonphysicians, research assistants, and associates in clinical trials (34%, n = 39). There was also diminished availability of workforce and funding to conduct observational cohort studies in nephrology, and participation in highly specialized transplant trials was low in many regions. Overall, the availability of infrastructure (bio-banking and facilities for storage of clinical trial medications) was low, and it was lowest in low-income and lower-middle-income countries. Ethics approval for study conduct was mandatory in 91% (n = 106) of countries and regions, and 62% (n = 66) were reported to have institutional committees. Challenges with obtaining timely approval for a study were reported in 53% (n = 61) of regions but the challenges were similar across these regions. A potential limitation is the possibility of over-reporting or under-reporting due to social desirability bias. This study highlights some of the major challenges for participating in and conducting kidney research and offers suggestions for improving global kidney research.

Figure 1

Worldwide distributionof chronic kidney disease (CKD) studies registered atClinicalTrials.gov. There is a huge disparity in distribution of studies between high- and low-income countries and regions.

Figure S1

Worldwide distribution of chronic kidney disease (CKD) studies registered at ClinicalTrials.gov according to study phase. (A) Phase 1. (B) Phase 2. (C) Phase 3. (D) Phase 4.