Literature DB >> 29733448

Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG).

Hongbo Yuan1, M Sanni Ali2,3, Emily S Brouwer4,5, Cynthia J Girman6, Jeff J Guo7, Jennifer L Lund8, Elisabetta Patorno9, Jonathan L Slaughter10, Xuerong Wen11, Dimitri Bennett12.   

Abstract

On December 8, 2016, the New England Journal of Medicine published a sounding board on Real World Evidence (RWE)1 by the US Food and Drug Administration (FDA) leadership. While the value of RWE based on nonrandomized observational studies was appreciated, such as for hypothesis generating, safety, and measuring quality in healthcare delivery, the authors expressed concerns on the quality of data sources and the ability of methodologies to control for confounding. In response, we offer a few considerations regarding these concerns.
© 2018 American Society for Clinical Pharmacology and Therapeutics.

Year:  2018        PMID： 29733448     DOI： 10.1002/cpt.1086

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


  5 in total

Review 1.  Propensity Score Methods in Health Technology Assessment: Principles, Extended Applications, and Recent Advances.

Authors:  M Sanni Ali; Daniel Prieto-Alhambra; Luciane Cruz Lopes; Dandara Ramos; Nivea Bispo; Maria Y Ichihara; Julia M Pescarini; Elizabeth Williamson; Rosemeire L Fiaccone; Mauricio L Barreto; Liam Smeeth
Journal:  Front Pharmacol       Date:  2019-09-18       Impact factor: 5.810

2.  How well can we assess the validity of non-randomised studies of medications? A systematic review of assessment tools.

Authors:  Elvira D'Andrea; Lydia Vinals; Elisabetta Patorno; Jessica M Franklin; Dimitri Bennett; Joan A Largent; Daniela C Moga; Hongbo Yuan; Xuerong Wen; Andrew R Zullo; Thomas P A Debray; Grammati Sarri
Journal:  BMJ Open       Date:  2021-03-24       Impact factor: 2.692

3.  Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making.

Authors:  Grammati Sarri; Elisabetta Patorno; Hongbo Yuan; Jianfei Jeff Guo; Dimitri Bennett; Xuerong Wen; Andrew R Zullo; Joan Largent; Mary Panaccio; Mugdha Gokhale; Daniela Claudia Moga; M Sanni Ali; Thomas P A Debray
Journal:  BMJ Evid Based Med       Date:  2020-12-09

4.  Identifying Patients With Inflammatory Bowel Diseases in an Administrative Health Claims Database: Do Algorithms Generate Similar Findings?

Authors:  Yizhou Ye; Sudhakar Manne; Dimitri Bennett
Journal:  Inquiry       Date:  2019 Jan-Dec       Impact factor: 1.730

Review 5.  Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review.

Authors:  Beate Aurich; Evelyne Jacqz-Aigrain
Journal:  Pharmaceutics       Date:  2021-05-11       Impact factor: 6.321
  5 in total

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