Abstract

Despite the high global burden of kidney disease, nephrology lags behind other medical disciplines in the availability of high-quality randomised controlled trials. In 2018, the International Society of Nephrology (ISN) surveyed nephrologists to better understand barriers to trial participation and identify potential areas for support. An online survey was developed by the ISN Advancing Clinical Trials (ISN-ACT) Group and emailed to 549 members across the 10 ISN regions between September and December 2018. Respondents were asked to indicate the extent to which different aspects of trial development and conduct were a barrier to their participation. Twenty-seven Likert items were grouped into five broad areas where barriers might arise: knowledge, time, research infrastructure, financial costs and patient factors. For the three most commonly reported barriers, associations between respondent characteristics and the perceived importance of the barrier were assessed using a Mann-Whitney test. Respondents were also asked to rate how valuable different activities would be in increasing their ability to participate in trials. The survey response rate was 32% (n = 177 respondents), of whom 137 responded to questions related to barriers to trial participation and were included in the analysis. There was at least one respondent from each of the 10 ISN regions, with 53 countries represented. One-fifth of respondents came from India. While 97% of respondents indicated an interest in RCTs, only 57% had dedicated time for research and 74% had previous trial experience. The most common barriers to participation was lack of funding opportunities (74% of respondents), financial compensation of research staff (55%) and time needed to manage research finances (45%). Individuals with no prior trial experience were more likely to report a lack of funding and staff remuneration as barriers to their participation (p-value < 0.0001 for both). Though knowledge was rarely reported a barrier to trial participation, 81-87% of respondents indicated that training in the design or conduct of clinicals trials would be highly or moderately valuable. Eighty percent of respondents deemed mentoring by a senior investigator to be valuable, while 85% reported that assistance with ethical and regulatory approval would be of use. Our survey findings suggest that funding is a major barrier to trial participation. Further work is necessary to understand the best ways to support individuals in engaging in trials research.

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