Literature DB >> 30883700

The US Food and Drug Administration's Real-World Evidence Framework: A Commitment for Engagement and Transparency on Real-World Evidence.

M Khair ElZarrad1, Jacqueline Corrigan-Curay1.   

Abstract

Year:  2019        PMID: 30883700     DOI: 10.1002/cpt.1389

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


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  6 in total

1.  The Medicines Intelligence Centre of Research Excellence: Co-creating real-world evidence to support the evidentiary needs of Australian medicines regulators and payers.

Authors:  Nicole Pratt; Ximena Camacho; Claire Vajdic; Louisa Degenhardt; Tracey-Lea Laba; Jodie Hillen; Christopher Etherton-Beer; David Preen; Louisa Jorm; Natasha Donnolley; Alys Havard; Sallie-Anne Pearson
Journal:  Int J Popul Data Sci       Date:  2022-06-13

2.  Indicators of retention in remote digital health studies: a cross-study evaluation of 100,000 participants.

Authors:  Abhishek Pratap; Elias Chaibub Neto; Phil Snyder; Carl Stepnowsky; Noémie Elhadad; Daniel Grant; Matthew H Mohebbi; Sean Mooney; Christine Suver; John Wilbanks; Lara Mangravite; Patrick J Heagerty; Pat Areán; Larsson Omberg
Journal:  NPJ Digit Med       Date:  2020-02-17

Review 3.  Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.

Authors:  Hans-Georg Eichler; Franz Koenig; Peter Arlett; Harald Enzmann; Anthony Humphreys; Frank Pétavy; Brigitte Schwarzer-Daum; Bruno Sepodes; Spiros Vamvakas; Guido Rasi
Journal:  Clin Pharmacol Ther       Date:  2019-10-01       Impact factor: 6.875

4.  Real-time autOmatically updated data warehOuse in healThcare (ROOT): an innovative and automated data collection system.

Authors:  Hyun Ae Jung; Oksoon Jeong; Dong Kyung Chang; Sehhoon Park; Jong-Mu Sun; Se-Hoon Lee; Jin Seok Ahn; Myung-Ju Ahn; Keunchil Park
Journal:  Transl Lung Cancer Res       Date:  2021-10

Review 5.  Use of Real-World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design.

Authors:  Simon Dagenais; Leo Russo; Ann Madsen; Jen Webster; Lauren Becnel
Journal:  Clin Pharmacol Ther       Date:  2021-11-28       Impact factor: 6.903

6.  Patient Satisfaction with Once-Daily Single-Tablet Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (DRV/c/FTC/TAF): A Real-World Study of Patient Self-Reported Outcomes in HIV-1-Diagnosed Adults.

Authors:  Joyce LaMori; Antoine Seignez; Lise Radoszycki
Journal:  Patient Prefer Adherence       Date:  2022-01-13       Impact factor: 2.711

  6 in total

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