Literature DB >> 28715550

Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data.

Jonathan P Jarow1, Lisa LaVange1, Janet Woodcock1.   

Abstract

Mesh：

Year:  2017        PMID： 28715550     DOI： 10.1001/jama.2017.9991

Source DB:  PubMed          Journal:  JAMA        ISSN： 0098-7484            Impact factor:   56.272


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  51 in total

1.  The Expanding Role of Real-World Evidence Trials in Health Care Decision Making.

Authors:  David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2019-03-06

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

Review 3.  Diabetes Technology and Therapy in the Pediatric Age Group.

Authors:  David M Maahs; Rayhan Lal; Shlomit Shalitin
Journal:  Diabetes Technol Ther       Date:  2019-02       Impact factor: 6.118

4.  Real-World Evidence: Promise and Peril For Medical Product Evaluation.

Authors:  Sanket S Dhruva; Joseph S Ross; Nihar R Desai
Journal:  P T       Date:  2018-08

5.  Pharmacoepidemiology in the era of real-world evidence.

Authors:  Sengwee Toh
Journal:  Curr Epidemiol Rep       Date:  2017-10-19

Review 6.  Use of Real-World Evidence in US Payer Coverage Decision-Making for Next-Generation Sequencing-Based Tests: Challenges, Opportunities, and Potential Solutions.

Authors:  Patricia A Deverka; Michael P Douglas; Kathryn A Phillips
Journal:  Value Health       Date:  2020-03-26       Impact factor: 5.725

7.  Validation and Refinement of a Pain Information Model from EHR Flowsheet Data.

Authors:  Bonnie L Westra; Steven G Johnson; Samira Ali; Karen M Bavuso; Christopher A Cruz; Sarah Collins; Meg Furukawa; Mary L Hook; Anne LaFlamme; Kay Lytle; Lisiane Pruinelli; Tari Rajchel; Theresa Tess Settergren; Kathryn F Westman; Luann Whittenburg
Journal:  Appl Clin Inform       Date:  2018-03-14       Impact factor: 2.342

Review 8.  Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies.

Authors:  Gita Thanarajasingam; Lori M Minasian; Frederic Baron; Franco Cavalli; R Angelo De Claro; Amylou C Dueck; Tarec C El-Galaly; Neil Everest; Jan Geissler; Christian Gisselbrecht; John Gribben; Mary Horowitz; S Percy Ivy; Caron A Jacobson; Armand Keating; Paul G Kluetz; Aviva Krauss; Yok Lam Kwong; Richard F Little; Francois-Xavier Mahon; Matthew J Matasar; María-Victoria Mateos; Kristen McCullough; Robert S Miller; Mohamad Mohty; Philippe Moreau; Lindsay M Morton; Sumimasa Nagai; Simon Rule; Jeff Sloan; Pieter Sonneveld; Carrie A Thompson; Kyriaki Tzogani; Flora E van Leeuwen; Galina Velikova; Diego Villa; John R Wingard; Sophie Wintrich; John F Seymour; Thomas M Habermann
Journal:  Lancet Haematol       Date:  2018-06-18       Impact factor: 18.959

9.  Clinical outcomes and complications between FLACS and conventional phacoemulsification cataract surgery: a PRISMA-compliant Meta-analysis of 25 randomized controlled trials.

Authors:  Li Chen; Chen Hu; Xiao Lin; Hao-Yu Li; Yi Du; Yi-Hua Yao; Jun Chen
Journal:  Int J Ophthalmol       Date:  2021-07-18       Impact factor: 1.779

Review 10.  Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain: a Retrospective Cohort Study in the US Fee-for-Service Medicare Population.

Authors:  Laxmaiah Manchikanti; Amol Soin; Dharam P Mann; Sanjay Bakshi; Vidyasagar Pampati; Alan D Kaye; Joshua A Hirsch
Journal:  Curr Pain Headache Rep       Date:  2019-08-06
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