Literature DB >> 23744001

Fostering innovation, advancing patient safety: the kidney health initiative.

Patrick Archdeacon1, Rachel N Shaffer, Wolfgang C Winkelmayer, Ronald J Falk, Prabir Roy-Chaudhury.   

Abstract

To respond to the serious and underrecognized epidemic of kidney disease in the United States, the US Food and Drug Administration and the American Society of Nephrology have founded the Kidney Health Initiative-a public-private partnership designed to create a collaborative environment in which the US Food and Drug Administration and the greater kidney community can interact to optimize the evaluation of drugs, devices, biologics, and food products. The Kidney Health Initiative will bring together all the necessary stakeholders, including patients, regulators, industry, health care providers, academics, and other governmental agencies, to improve patient safety and foster innovation. This initiative is intended to enable the kidney community as a whole to provide the right drug, device, or biologic for administration to the right patient at the right time by fostering partnerships that will facilitate development and delivery of those products and addressing challenges that currently impede these goals.

Entities:  

Mesh:

Year:  2013        PMID: 23744001      PMCID: PMC3805066          DOI: 10.2215/CJN.01140113

Source DB:  PubMed          Journal:  Clin J Am Soc Nephrol        ISSN: 1555-9041            Impact factor:   8.237


  6 in total

Review 1.  The number, quality, and coverage of randomized controlled trials in nephrology.

Authors:  Giovanni F M Strippoli; Jonathan C Craig; Francesco P Schena
Journal:  J Am Soc Nephrol       Date:  2004-02       Impact factor: 10.121

Review 2.  The FDA critical path initiative and its influence on new drug development.

Authors:  Janet Woodcock; Raymond Woosley
Journal:  Annu Rev Med       Date:  2008       Impact factor: 13.739

3.  Trial quality in nephrology: how are we measuring up?

Authors:  Suetonia C Palmer; Michela Sciancalepore; Giovanni F M Strippoli
Journal:  Am J Kidney Dis       Date:  2011-09       Impact factor: 8.860

4.  Loss to analysis in randomized controlled trials in CKD.

Authors:  Aneet Deo; Christopher H Schmid; Amy Earley; Joseph Lau; Katrin Uhlig
Journal:  Am J Kidney Dis       Date:  2011-07-20       Impact factor: 8.860

5.  Prevalence of chronic kidney disease in the United States.

Authors:  Josef Coresh; Elizabeth Selvin; Lesley A Stevens; Jane Manzi; John W Kusek; Paul Eggers; Frederick Van Lente; Andrew S Levey
Journal:  JAMA       Date:  2007-11-07       Impact factor: 56.272

6.  Temporal changes in incidence of dialysis-requiring AKI.

Authors:  Raymond K Hsu; Charles E McCulloch; R Adams Dudley; Lowell J Lo; Chi-yuan Hsu
Journal:  J Am Soc Nephrol       Date:  2012-12-06       Impact factor: 10.121

  6 in total
  27 in total

1.  Hemodiafiltration to Address Unmet Medical Needs ESKD Patients.

Authors:  Bernard Canaud; Jörg Vienken; Stephen Ash; Richard A Ward
Journal:  Clin J Am Soc Nephrol       Date:  2018-03-06       Impact factor: 8.237

Review 2.  Perspectives from the Kidney Health Initiative on Advancing Technologies to Facilitate Remote Monitoring of Patient Self-Care in RRT.

Authors:  Mitchell H Rosner; Susie Q Lew; Paul Conway; Jennifer Ehrlich; Robert Jarrin; Uptal D Patel; Karen Rheuban; R Brooks Robey; Neal Sikka; Eric Wallace; Patrick Brophy; James Sloand
Journal:  Clin J Am Soc Nephrol       Date:  2017-07-14       Impact factor: 8.237

Review 3.  Strategies for postmarketing surveillance of drugs and devices in patients with ESRD undergoing dialysis.

Authors:  Moshe Vardi; Robert W Yeh; Charles A Herzog; Wolfgang C Winkelmayer; Soko Setoguchi; David M Charytan
Journal:  Clin J Am Soc Nephrol       Date:  2013-08-22       Impact factor: 8.237

4.  End Points for Clinical Trials in Primary Hyperoxaluria.

Authors:  Dawn S Milliner; Tracy L McGregor; Aliza Thompson; Bastian Dehmel; John Knight; Ralf Rosskamp; Melanie Blank; Sixun Yang; Sonia Fargue; Gill Rumsby; Jaap Groothoff; Meaghan Allain; Melissa West; Kim Hollander; W Todd Lowther; John C Lieske
Journal:  Clin J Am Soc Nephrol       Date:  2020-03-12       Impact factor: 8.237

Review 5.  FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access.

Authors:  Frank P Hurst; Robert E Lee; Aliza M Thompson; Brian D Pullin; Douglas M Silverstein
Journal:  Clin J Am Soc Nephrol       Date:  2017-07-24       Impact factor: 8.237

6.  The New HHS Kidney Innovation Accelerator: When Innovation Stalls, HHS Says Floor it!

Authors:  Kevin John Fowler; Paul T Conway
Journal:  Clin J Am Soc Nephrol       Date:  2018-10-25       Impact factor: 8.237

7.  Guidelines for clinical evaluation of chronic kidney disease : AMED research on regulatory science of pharmaceuticals and medical devices.

Authors:  Eiichiro Kanda; Naoki Kashihara; Kunihiro Matsushita; Tomoko Usui; Hirokazu Okada; Kunitoshi Iseki; Kenichi Mikami; Tetsuhiro Tanaka; Takashi Wada; Hirotaka Watada; Kohjiro Ueki; Masaomi Nangaku
Journal:  Clin Exp Nephrol       Date:  2018-12       Impact factor: 2.801

8.  Improving Clinical Outcomes in the Era of Information Ubiquity.

Authors:  Robert M Califf
Journal:  J Am Soc Nephrol       Date:  2019-01       Impact factor: 10.121

Review 9.  Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access.

Authors:  Gerald A Beathard; Charmaine E Lok; Marc H Glickman; Ahmed A Al-Jaishi; Donna Bednarski; David L Cull; Jeffery H Lawson; Timmy C Lee; Vandana D Niyyar; Donna Syracuse; Scott O Trerotola; Prabir Roy-Chaudhury; Surendra Shenoy; Margo Underwood; Haimanot Wasse; Karen Woo; Theodore H Yuo; Thomas S Huber
Journal:  Clin J Am Soc Nephrol       Date:  2017-07-20       Impact factor: 8.237

Review 10.  Challenges and novel therapies for vascular access in haemodialysis.

Authors:  Jeffrey H Lawson; Laura E Niklason; Prabir Roy-Chaudhury
Journal:  Nat Rev Nephrol       Date:  2020-08-24       Impact factor: 28.314

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