Literature DB >> 30841738

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

David C Klonoff1.   

Abstract

Real-world evidence (RWE) is the clinical evidence about benefits or risks of medical products derived from analyzing real world data (RWD), which are data collected through routine clinical practice. This article discusses the advantages and disadvantages of RWE studies, how these studies differ from randomized controlled trials (RCTs), how to overcome barriers to current skepticism about RWE, how FDA is using RWE, how to improve the quality of RWE, and finally the future of RWE trials.

Keywords:  FDA; observational; pragmatic; randomized controlled trial; real-world evidence

Mesh：

Year:  2019        PMID： 30841738      PMCID： PMC7189159          DOI： 10.1177/1932296819832653

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN： 1932-2968


  38 in total

1.  Making inferences on treatment effects from real world data: propensity scores, confounding by indication, and other perils for the unwary in observational research.

Authors:  Nick Freemantle; Louise Marston; Kate Walters; John Wood; Matthew R Reynolds; Irene Petersen
Journal:  BMJ       Date:  2013-11-11

2.  Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.

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Journal:  Value Health       Date:  2017-09-15       Impact factor: 5.725

3.  An investigation into the durability of glycemic control in patients with type II diabetes initiated on canagliflozin or sitagliptin: A real-world analysis of electronic medical records.

Authors:  Carol H Wysham; Patrick Lefebvre; Dominic Pilon; Marie-Hélène Lafeuille; Bruno Emond; Rhiannon Kamstra; Michael Pfeifer; Mei Sheng Duh; Mike Ingham
Journal:  J Diabetes Complications       Date:  2018-10-31       Impact factor: 2.852

Review 4.  A pragmatic view on pragmatic trials.

Authors:  Nikolaos A Patsopoulos
Journal:  Dialogues Clin Neurosci       Date:  2011       Impact factor: 5.986

5.  Mining personal data using smartphones and wearable devices: a survey.

Authors:  Muhammad Habib ur Rehman; Chee Sun Liew; Teh Ying Wah; Junaid Shuja; Babak Daghighi
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6.  Unmeasured Confounders in Observational Studies Comparing Bilateral Versus Single Internal Thoracic Artery for Coronary Artery Bypass Grafting: A Meta-Analysis.

Authors:  Mario Gaudino; Antonino Di Franco; Mohamed Rahouma; Derrick Y Tam; Mario Iannaccone; Saswata Deb; Fabrizio D'Ascenzo; Ahmed A Abouarab; Leonard N Girardi; David P Taggart; Stephen E Fremes
Journal:  J Am Heart Assoc       Date:  2018-01-06       Impact factor: 5.501

Review 7.  The value of pragmatic and observational studies in health care and public health.

Authors:  Maxwell S Barnish; Steve Turner
Journal:  Pragmat Obs Res       Date:  2017-05-12

8.  Data sharing and the future of science.

Authors: 
Journal:  Nat Commun       Date:  2018-07-19       Impact factor: 14.919

Review 9.  Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012.

Authors:  Jennifer E Miller; David Korn; Joseph S Ross
Journal:  BMJ Open       Date:  2015-11-12       Impact factor: 2.692

10.  Development and Validation of a High-Quality Composite Real-World Mortality Endpoint.

Authors:  Melissa D Curtis; Sandra D Griffith; Melisa Tucker; Michael D Taylor; William B Capra; Gillis Carrigan; Ben Holzman; Aracelis Z Torres; Paul You; Brandon Arnieri; Amy P Abernethy
Journal:  Health Serv Res       Date:  2018-05-14       Impact factor: 3.402
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  9 in total

1.  Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices.

Authors:  David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2019-04-11

2.  The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial.

Authors:  Liana K Billings; Bue F Ross Agner; Yuksel Altuntas; Randi Grøn; Natalie Halladin; David C Klonoff; Nikolaos Tentolouris; Esteban Jódar
Journal:  J Diabetes Sci Technol       Date:  2020-02-28

3.  Continuous Ketone Monitoring Consensus Report 2021.

Authors:  Kevin T Nguyen; Nicole Y Xu; Jennifer Y Zhang; Trisha Shang; Ananda Basu; Richard M Bergenstal; Kristin Castorino; Kong Y Chen; David Kerr; Suneil K Koliwad; Lori M Laffel; Nestoras Mathioudakis; L Kurt Midyett; Joshua D Miller; James H Nichols; Francisco J Pasquel; Priya Prahalad; Mark R Prausnitz; Jane Jeffrie Seley; Jennifer L Sherr; Elias K Spanakis; Guillermo E Umpierrez; Amisha Wallia; David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2021-10-04

4.  Generalizing findings from a randomized controlled trial to a real-world study of the iLookOut, an online education program to improve early childhood care and education providers' knowledge and attitudes about reporting child maltreatment.

Authors:  Chengwu Yang; Carlo Panlilio; Nicole Verdiglione; Erik B Lehman; Robert M Hamm; Richard Fiene; Sarah Dore; David E Bard; Breanna Grable; Benjamin Levi
Journal:  PLoS One       Date:  2020-01-08       Impact factor: 3.240

5.  Generating real-world evidence from unstructured clinical notes to examine clinical utility of genetic tests: use case in BRCAness.

Authors:  Yiqing Zhao; Saravut J Weroha; Ellen L Goode; Hongfang Liu; Chen Wang
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6.  Analysis of a Real-World Progression Variable and Related Endpoints for Patients with Five Different Cancer Types.

Authors:  Aracelis Z Torres; Nathan C Nussbaum; Christina M Parrinello; Ariel B Bourla; Bryan E Bowser; Samuel Wagner; David C Tabano; Daniel George; Rebecca A Miksad
Journal:  Adv Ther       Date:  2022-04-17       Impact factor: 4.070

7.  Development and validation of a novel model for characterizing migraine outcomes within real-world data.

Authors:  Nada A Hindiyeh; Daniel Riskin; Kimberly Alexander; Roger Cady; Steven Kymes
Journal:  J Headache Pain       Date:  2022-09-21       Impact factor: 8.588

8.  Demographic Characteristics and Treatment Patterns Among Patients Receiving Palbociclib for HR+/HER2- Advanced Breast Cancer: A Nationwide Real-World Experience.

Authors:  Katalin Boér; Gábor Rubovszky; György Rokszin; Zsolt Abonyi-Tóth; Csenge Földesi; Magdolna Dank
Journal:  Onco Targets Ther       Date:  2021-07-01       Impact factor: 4.147

9.  Angiotensin-Converting Enzyme Inhibitors, Angiotensin Receptor Blockers, and COVID-19: Demonstrating the Actionability of Real-World Evidence.

Authors:  Sean Hennessy; Jordana B Cohen
Journal:  Am J Hypertens       Date:  2021-04-20       Impact factor: 3.080
  9 in total

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