MO840ADAPTIVE DESIGN METHODS IN DIALYSIS CLINICAL TRIALS – A SYSTEMATIC REVIEW

Abstract

Abstract Background and Aims Adaptive design methods are intended to improve efficiency of clinical trials, and relevant to evaluating interventions in dialysis populations. We sought to quantify the use of adaptive design clinical trials in dialysis. Method We completed a full text systematic review and adhered to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Our review utilised included a novel machine learning classifier and full text systematic review. We searched MEDLINE (Pubmed) and performed a detailed data extraction of trial characteristics and a narrative synthesis of the data. Results 50 studies, available as 66 articles, were included after full text review. 31 studies were conducted in a dialysis population and 23 studies had renal replacement therapy as a primary or secondary outcome. Group sequential designs were the most common type of adaptive design method used in dialysis randomized clinical trials and in general adaptive designs usage is increasing over time. Acute Kidney Injury (AKI) was studied in 27 (54%) of trials, End Stage Kidney Disease (ESKD) was studied in 22 (44%) of trials and Chronic Kidney Disease (CKD) was studied in one trial (2%). The most common country of lead author was the United States of America in n=20 (40%) of studies. 26 (52%) studies were supported by public funding. 41 studies (82%) did not report their adaptive design method in the title or abstract and would not be detected by a standard systematic review involving title and abstract searches. Conclusion Adaptive design methods are infrequently used in dialysis randomized control trials.