title: Should We Still Believe in Randomized Controlled Trials in Nephrology?
abstract: The randomized controlled trial (RCT) is the cornerstone upon which clinical decision-making is based. Pivotal RCTs in the nephrology area efficiently demonstrated the renoprotective effects of treatment with renin-angiotensin system inhibitors in patients with diabetic and non-diabetic proteinuric nephropathies. However, there is concern about the increasing cost, complexity and duration of clinical studies. Moreover, recent large RCTs addressing key issues for patients with renal disease failed to achieve definitive conclusions mainly due to critical flaws in the investigational strategies, including the adoption of excessive/fixed doses of the study medications, inappropriate use of the placebo-controlled design, enrollment of low-risk individuals, poor reporting of adverse events or unreliable evaluation of renal function. The information now available on the biases that characterize the current RCTs should serve as a tool to rethink the design, patient selection and implementation of future RCTs in nephrology.
authors.affiliation: Clinical Research Center for Rare Diseases 'Aldo and Cele Daccò', IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Bergamo, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Cortinovis
authors.forename: Norberto
authors.initials: N
authors.lastname: Perico
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Remuzzi
mesh_terms: D006801:Humans; D007674:Kidney Diseases / Q000188:drug therapy; D009398:Nephrology / Q000379:methods / Q000639:trends*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design
keywords: Nephrology; Randomized double-blind trial; Renal diseases