Literature DB >> 30485777

The FDA Sentinel Initiative - An Evolving National Resource.

Richard Platt1, Jeffrey S Brown1, Melissa Robb1, Mark McClellan1, Robert Ball1, Michael D Nguyen1, Rachel E Sherman1.   

Abstract

Mesh：

Year:  2018        PMID： 30485777     DOI： 10.1056/NEJMp1809643

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  43 in total

1.  Using Real-World Data to Predict Findings of an Ongoing Phase IV Cardiovascular Outcome Trial: Cardiovascular Safety of Linagliptin Versus Glimepiride.

Authors:  Elisabetta Patorno; Sebastian Schneeweiss; Chandrasekar Gopalakrishnan; David Martin; Jessica M Franklin
Journal:  Diabetes Care       Date:  2019-06-25       Impact factor: 19.112

2.  The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics.

Authors:  David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2019-03-12

3.  Using and improving distributed data networks to generate actionable evidence: the case of real-world outcomes in the Food and Drug Administration's Sentinel system.

Authors:  Jeffrey S Brown; Judith C Maro; Michael Nguyen; Robert Ball
Journal:  J Am Med Inform Assoc       Date:  2020-05-01       Impact factor: 4.497

Review 4.  Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.

Authors:  Sruthi Adimadhyam; Erin F Barreto; Noelle M Cocoros; Sengwee Toh; Jeffrey S Brown; Judith C Maro; Jacqueline Corrigan-Curay; Gerald J Dal Pan; Robert Ball; David Martin; Michael Nguyen; Richard Platt; Xiaojuan Li
Journal:  J Am Soc Nephrol       Date:  2020-10-19       Impact factor: 10.121

5.  Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy.

Authors:  Janet Sultana; Francesco Trotta; Antonio Addis; Jeffrey S Brown; Miguel Gil; Francesca Menniti-Ippolito; Federica Milozzi; Samy Suissa; Gianluca Trifirò
Journal:  Drug Saf       Date:  2020-01       Impact factor: 5.606

6.  Evaluation of the US Food and Drug Administration Sentinel Analysis Tools Using a Comparator with a Different Indication: Comparing the Rates of Gastrointestinal Bleeding in Warfarin and Statin Users.

Authors:  Ryan M Carnahan; Joshua J Gagne; Christian Hampp; Charles E Leonard; Sengwee Toh; Candace C Fuller; Sean Hennessy; Laura Hou; Noelle M Cocoros; Genna Panucci; Tiffany Woodworth; Austin Cosgrove; Aarthi Iyer; Elizabeth A Chrischilles
Journal:  Pharmaceut Med       Date:  2019-02

7.  Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement.

Authors:  Neel M Butala; Jordan B Strom; Kamil F Faridi; Dhruv S Kazi; Yuansong Zhao; J Matthew Brennan; Jeffrey J Popma; Changyu Shen; Robert W Yeh
Journal:  JACC Cardiovasc Interv       Date:  2020-07-15       Impact factor: 11.195

8.  Chemotherapy-induced peripheral neuropathy (CIPN) and its treatment: an NIH Collaboratory study of claims data.

Authors:  Jennifer S Gewandter; Amber S Kleckner; James H Marshall; Jeffrey S Brown; Lesley H Curtis; Javier Bautista; Robert H Dworkin; Ian R Kleckner; Noah Kolb; Supriya G Mohile; Karen M Mustian
Journal:  Support Care Cancer       Date:  2019-09-07       Impact factor: 3.603

9.  Regulatory-grade clinical trial design using real-world data.

Authors:  Mark S Levenson
Journal:  Clin Trials       Date:  2020-02-17       Impact factor: 2.486

10.  Artificial Intelligence, Real-World Automation and the Safety of Medicines.

Authors:  Andrew Bate; Steve F Hobbiger
Journal:  Drug Saf       Date:  2020-10-07       Impact factor: 5.606
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