Fostering innovation, advancing patient safety: The kidney health initiative

Clinical Journal of the American Society of Nephrology

Volumn 8, Issue 9, 2013, Pages 1609-1617

  Archdeacon, Patrick ^a   Shaffer, Rachel N ^b   Winkelmayer, Wolfgang C ^c   Falk, Ronald J ^d   Roy Chaudhury, Prabir ^e  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b American Society of Nephrology   (United States)

^c STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGALSIDASE BETA; ALFUZOSIN; BELATACEPT; BEVACIZUMAB; CABAZITAXEL; CARBOXYPEPTIDASE G2; CARGLUMIC ACID; CINACALCET; CONIVAPTAN; CONTINUOUS ERYTHROPOIESIS RECEPTOR ACTIVATOR; DEGARELIX; DORIPENEM; DUTASTERIDE PLUS TAMSULOSIN; ECULIZUMAB; EVEROLIMUS; FERUMOXYTOL; FESOTERODINE; LANTHANUM CARBONATE; LEUPRORELIN; MESNA; OXYBUTYNIN; PAZOPANIB; REGORAFENIB; RIFAXIMIN; SEVELAMER CARBONATE; SIPULEUCEL T; SOLIFENACIN; TEMSIROLIMUS; TROSPIUM CHLORIDE; UNINDEXED DRUG;

ABDOMINAL INFECTION; ANEMIA; ARTICLE; CHRONIC KIDNEY DISEASE; CLINICAL RESEARCH; COLORECTAL CANCER; DIABETES MELLITUS; DRUG ELIMINATION; DRUG SCREENING; FABRY DISEASE; FOOD AND DRUG ADMINISTRATION; FOOD SAFETY; GRAFT REJECTION; HEALTH CARE PERSONNEL; HEMOLYTIC UREMIC SYNDROME; HEMORRHAGIC CYSTITIS; HEPATIC ENCEPHALOPATHY; HUMAN; HYPERAMMONEMIA; HYPERPHOSPHATEMIA; HYPERTENSION; HYPONATREMIA; KIDNEY CARCINOMA; KIDNEY DISEASE; KIDNEY POLYCYSTIC DISEASE; LUPUS ERYTHEMATOSUS NEPHRITIS; MORBIDITY; MORTALITY; NATIONAL HEALTH ORGANIZATION; NEPHROLOGY; OVERACTIVE BLADDER; PATIENT SAFETY; PROSTATE CANCER; PROSTATE HYPERTROPHY; PUBLIC-PRIVATE PARTNERSHIP; RANDOMIZED CONTROLLED TRIAL (TOPIC); SECONDARY HYPERPARATHYROIDISM; URINARY TRACT INFECTION;

ENDPOINT DETERMINATION; HUMANS; INVENTIONS; KIDNEY DISEASES; NEPHROLOGY; PATIENT SAFETY; PUBLIC-PRIVATE SECTOR PARTNERSHIPS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SOCIETIES, MEDICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84883673162     PISSN: 15559041     EISSN: 1555905X     Source Type: Journal    
DOI: 10.2215/CJN.01140113     Document Type: Article

References (16)

1. Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS: Prevalence of chronic kidney disease in the United States. JAMA 298: 2038-2047, 2007
2. US Renal Data System: USRDS Annual Data Report: 2012. Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2012
3. National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC): Kidney Disease Statistics for the United States, 2013. Available at: http://kidney.niddk.nih.gov/kudiseases/pubs/kustats/. Accessed January 18, 2013
4. Hsu RK, McCulloch CE, Dudley RA, Lo LJ, Hsu CY: Temporal changes in incidence of dialysis-requiring AKI. J Am Soc Nephrol 24: 37-42, 2013
5. Strippoli GF, Craig JC, Schena FP: The number, quality, and coverage of randomized controlled trials in nephrology. J Am Soc Nephrol 15: 411-419, 2004
6. Palmer SC, Sciancalepore M, Strippoli GF: Trial quality in nephrology: How are we measuring up? Am J Kidney Dis 58: 335-337, 2011
7. Deo A, Schmid CH, Earley A, Lau J, Uhlig K: Loss to analysis in randomized controlled trials in CKD. Am J Kidney Dis 58: 349-355, 2011
8. Center Watch. FDA Approved Drugs. 2013. Available at: http://www.centerwatch.com/drug-information/fda-approvals/. Accessed January 8, 2013
9. US Food and Drug Administration: How Many People Are Employed by FDA and in What Areas Do They Work?, 2013. Available at: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213161.htm. Accessed January 18, 2013
10. Hutt PB, Merrill RA, Grossman LA: Food and Drug Law: Cases and Materials, 3rd Ed. Foundation Press, New York, 2007, pp 26-27
11. US Food and Drug Administration: FDA's Critical Path Initiative, 2013. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ucm076689.htm. Accessed January 18, 2013
12. US Food and Drug Administration: Innovation or Stagnation: Challenge and Opportunities on the Critical Path to New Medical Products, 2013. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm. Accessed January 18, 2013
13. Woodcock J, Woosley R: The FDA critical path initiative and its influence on new drug development. Annu Rev Med 59: 1-12, 2008
14. Clinical Trials Transformation Initiative. About Us. Available at: http://www.ctti-clinicaltrials.org. Accessed January 18, 2013
15. Cardiac Safety Research Consortium. About Us. Available at: http://www.cardiac-safety.org/. Accessed January 18, 2013
16. American Society of Nephrology: Kidney Health Initiative Conflict of Interest Policy, 2013. Available at: http://www.asn-online.org/khi/coi.aspx. Accessed January 18, 2013