The Landscape of Clinical Trials in Nephrology: A Systematic Review of ClinicalTrials.gov

Abstract

Background Well-designed trials are of paramount importance in improving the delivery of care to patients with kidney disease. However, it remains unknown whether contemporary clinical trials within nephrology are of sufficient quality and quantity to meet this need. Study Design Systematic review. Setting & Population Studies registered with ClinicalTrials.gov. Selection Criteria for Studies Interventional (i.e., non-observational) studies (both randomized and nonrandomized) registered between October 2007 and September 2010 were included for analysis. Studies were independently reviewed by physicians and classified by clinical specialty. Predictor Nephrology versus cardiology versus other trials. Outcomes Select clinical trial characteristics. Results Of the 40,970 trials overall, 1054 (2.6%) were classified as nephrology. The majority of nephrology trials were for treatment (75.4%) or prevention (15.7%), with very few diagnostic, screening, or health services research studies. Most nephrology trials were randomized (72.3%), including 24.9% that included a single study group, 64.0% that included parallel groups, and 9.4% that were crossover trials. Nephrology trials, compared with 2264 cardiology trials (5.5% overall), were more likely to be smaller (64.5% versus 48.0% enrolling ≤100 patients), phase I-II (29.0% versus 19.7%), and unblinded (66.2% versus 53.3%; P<0.05 for all). Nephrology trials were also more likely than cardiology trials to include a drug intervention (72.4% versus 41.9%) and were less likely to report having a data monitoring committee (40.3% versus 48.5%; P<0.05 for all). Finally, there were few trials funded by the National Institutes of Health (3.3%, nephrology; 4.2%, cardiology). Limitations Does not include all trials performed worldwide, and frequent categorization of funding source as university may underestimate NIH support. Conclusions Critical differences remain between clinical trials in nephrology and other specialties. Improving care for patients with kidney disease will require a concerted effort to increase the scope, quality, and quantity of clinical trials within nephrology.

A future for nephrology?

“…Clinical trials research, an area where Nephrology has fallen greatly behind other disciplines, 5 may see a renaissance. But this will require a level of National and International co-operation that has not yet been broadly achieved.…”

Znanost temeljena na dokazima u nefrologiji, dijalizi i transplantaciji bubrega

“…Nakon radova Strippolija i suradnika publicirano je nekoliko preglednih članaka koji su na različite načine kritički sagledavali stanje u nefrologiji. Inrig sa suradnicima je 2014. godine publicirala sustavni pregledni članak o kliničkim studijama u nefrologiji registriranim u ClinicalTrials.gov s ciljem da odgovori na pitanje o kvaliteti publiciranih studija u nefrologiji 8 . U ispitivanom periodu od 2007. do 2010. godine ukupno je bilo registrirano 40,970 studija, od čega 2,6 % u području nefrologije i 5,5 % u području kardiologije.…”

“…U ispitivanom periodu od 2007. do 2010. godine ukupno je bilo registrirano 40,970 studija, od čega 2,6 % u području nefrologije i 5,5 % u području kardiologije. Randomiziranih je bilo nešto manje od tri četvrtine (72,3 %), intervencijskih 75,4 %, a u usporedbi s kardiološkim studijama uključivali su manji broj pacijenata (više od 50 % manje od 100 pacijenata); slijepih studija bilo je svega trećina (33,8 %) 8 . Prema populaciji nefroloških pacijenata u nešto manje od trećine studija bili su pacijenti s kroničnom bubrežnom bolesti ( .…”

Complementary Initiatives from the NIDDK to Advance Kidney Health

“…No effective therapies currently exist for AKI, and the few drugs approved for CKD do not work consistently across the CKD population (1,2). Relatively few trials occur in nephrology compared with other medical specialties (3,4), and many of the interventions tested in recent AKI and CKD trials have had negative results-often sending us back to the drawing board.…”