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The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials.gov.

ABSTRACT: 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.Systematic review.Studies registered with ClinicalTrials.gov.Interventional (ie, nonobservational) studies (both randomized and nonrandomized) registered between October 2007 and September 2010 were included for analysis. Studies were reviewed independently by physicians and classified by clinical specialty.Nephrology versus cardiology versus other trials.Select clinical trial characteristics.Of 40,970 trials overall, 1,054 (2.6%) were classified as nephrology. Most 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%). Study designs included 24.9% with a single study group, 64.0% that included parallel groups, and 9.4% that were crossover trials. Nephrology trials, compared with 2,264 cardiology trials (5.5% overall), were more likely to be smaller (64.5% vs 48.0% enrolling?100 patients), phases 1-2 (29.0% vs 19.7%), and unblinded (66.2% vs 53.3%; P<0.05 for all). Nephrology trials also were more likely than cardiology trials to include a drug intervention (72.4% vs 41.9%) and less likely to report having a data monitoring committee (40.3% vs 48.5%; P<0.05 for all). Finally, there were few trials funded by the National Institutes of Health (NIH; 3.3%, nephrology; 4.2%, cardiology).Does not include all trials performed worldwide, and frequent categorization of funding source as university may underestimate NIH support.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.

SUBMITTER: Inrig JK

PROVIDER: S-EPMC3988265 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials.gov.

Inrig Jula K JK Califf Robert M RM Tasneem Asba A Vegunta Radha K RK Molina Christopher C Stanifer John W JW Chiswell Karen K Patel Uptal D UD

American journal of kidney diseases : the official journal of the National Kidney Foundation 20131206 5

<h4>Background</h4>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.<h4>Study design</h4>Systematic review.<h4>Setting & population</h4>Studies registered with ClinicalTrials.gov.<h4>Selection criteria for studies</h4>Interventional (ie, nonobservational) studies (both randomized and nonrando ...[more]

PMID: 24315119

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Project description:Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1?year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1?year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0.51-0.83)). Conclusion A total of 15% of pulmonary clinical highly likely applicable clinical trials report basic summary results to ClinicalTrials.gov within 1?year of trial completion. Strategies to improve reporting are needed within the pulmonary community.

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The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials.gov.

Publications

The landscape of clinical trials in nephrology: a systematic review of Clinicaltrials.gov.

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