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Despite this, therapeutic innovation remains limited: no European Medicines Agency\u2013approved treatment exists for acute kidney injury, and no drugs have demonstrated survival benefits in patients on dialysis. Randomized controlled clinical trials, although pivotal for advancing care, face persistent challenges in nephrology, including patient heterogeneity, multimorbidity, high dropout rates and small populations in rare diseases. In Europe, these intrinsic obstacles are compounded by fragmented implementation of the Clinical Trials Regulation (536\/2014), excessive safety reporting demands and lack of nephrology-specific guidance, discouraging academic-led initiatives and limiting pragmatic research. The Coalition for Reducing Bureaucracy in Clinical Trials, a broad alliance of medical societies and patient advocates, has recently published the \u2018Clinical research in Europe: putting quality and patient safety first\u2019 recommendations calling for regulatory harmonization, simplified safety reporting and patient-centred consent. The European Renal Association, a member of the Coalition and contributor to the report, fully supports these recommendations. Implementing such measures is critical to fostering efficient, high-quality nephrology trials in Europe and delivering urgently needed, evidence-based, life-saving and safe therapies for patients with kidney disease.<\/jats:p>","DOI":"10.1093\/ndt\/gfag007","type":"journal-article","created":{"date-parts":[[2026,1,23]],"date-time":"2026-01-23T12:42:55Z","timestamp":1769172175000},"page":"1161-1170","source":"Crossref","is-referenced-by-count":0,"title":["Randomized controlled trials in Europe: a call to action to protect national healthcare systems from the upcoming tsunami of kidney failure"],"prefix":"10.1093","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9805-9523","authenticated-orcid":false,"given":"Alberto","family":"Ortiz","sequence":"first","affiliation":[{"name":"Health Research Institute-Fundaci\u00f3n Jim\u00e9nez D\u00edaz University Hospital, Universidad Aut\u00f3noma de Madrid (IIS-FJD, UAM) Department of Nephrology and Hypertension, , Madrid ,","place":["Spain"]},{"name":"RICORS2040-renal , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mustafa","family":"Arici","sequence":"additional","affiliation":[{"name":"Hacettepe University Faculty of Medicine , Department of Nephrology, Ankara ,","place":["Turkiye"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitrios S","family":"Goumenos","sequence":"additional","affiliation":[{"name":"Patras University Hospital Department of Nephrology and Renal Transplantation, , Patras ,","place":["Greece"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcin","family":"Adamczak","sequence":"additional","affiliation":[{"name":"Transplantation and Internal Medicine, Medical University of Silesia Department of Nephrology, , Katowice ,","place":["Poland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathrin","family":"Eller","sequence":"additional","affiliation":[{"name":"Medical University of Graz , Department of Internal Medicine, Clinical Division of Nephrology, Graz ,","place":["Austria"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Carina","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Centro Hospitalar e Universit\u00e1rio de Lisboa Central, Lisbon, Portugal; NOVA Medical School Nephrology Department \u2013 , Lisbon ,","place":["Portugal"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Grandaliano","sequence":"additional","affiliation":[{"name":"U.O.C. Nefrologia e Dialisi, Fondazione Policlinico Universitario \u201cA. Gemelli\u201d IRCCS, Universit\u00e0 Cattolica del Sacro Cuore , Rome ,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kitty J","family":"Jager","sequence":"additional","affiliation":[{"name":"ERA Registry, Amsterdam UMC location University of Amsterdam , Department of Medical Informatics, Amsterdam ,","place":["The Netherlands"]},{"name":"Amsterdam Public Health Research Institute, Quality of Care and Ageing and Later Life , Amsterdam ,","place":["The Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer S","family":"Lees","sequence":"additional","affiliation":[{"name":"University of Glasgow, School of Cardiovascular and Metabolic Health , Glasgow ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vassilios","family":"Liakopoulos","sequence":"additional","affiliation":[{"name":"Aristotle University of Thessaloniki, Division of Nephrology and Hypertension , 1st Department of Internal 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