Literature DB >> 30105359

Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness.

Jacqueline Corrigan-Curay1, Leonard Sacks1, Janet Woodcock1.   

Abstract

Mesh：

Year:  2018        PMID： 30105359     DOI： 10.1001/jama.2018.10136

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


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  86 in total

1.  Design and Evaluation of an External Control Arm Using Prior Clinical Trials and Real-World Data.

Authors:  Steffen Ventz; Albert Lai; Timothy F Cloughesy; Patrick Y Wen; Lorenzo Trippa; Brian M Alexander
Journal:  Clin Cancer Res       Date:  2019-06-07       Impact factor: 12.531

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.  Practical Application of Real-World Evidence in Developing Cancer Therapies.

Authors:  Marjorie G Zauderer
Journal:  JCO Clin Cancer Inform       Date:  2019-07

Review 4.  Risks and Benefits of Attention-Deficit/Hyperactivity Disorder Medication on Behavioral and Neuropsychiatric Outcomes: A Qualitative Review of Pharmacoepidemiology Studies Using Linked Prescription Databases.

Authors:  Zheng Chang; Laura Ghirardi; Patrick D Quinn; Philip Asherson; Brian M D'Onofrio; Henrik Larsson
Journal:  Biol Psychiatry       Date:  2019-04-17       Impact factor: 13.382

5.  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

6.  Association of Antidepressant Use With Adverse Health Outcomes: A Systematic Umbrella Review.

Authors:  Elena Dragioti; Marco Solmi; Angela Favaro; Paolo Fusar-Poli; Paola Dazzan; Trevor Thompson; Brendon Stubbs; Joseph Firth; Michele Fornaro; Dimitrios Tsartsalis; Andre F Carvalho; Eduard Vieta; Philip McGuire; Allan H Young; Jae Il Shin; Christoph U Correll; Evangelos Evangelou
Journal:  JAMA Psychiatry       Date:  2019-12-01       Impact factor: 21.596

7.  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

8.  Mobile apps for real-world evidence in health care.

Authors:  Madison Milne-Ives; Michelle Helena van Velthoven; Edward Meinert
Journal:  J Am Med Inform Assoc       Date:  2020-06-01       Impact factor: 4.497

9.  Methodological considerations when analysing and interpreting real-world data.

Authors:  Til Stürmer; Tiansheng Wang; Yvonne M Golightly; Alex Keil; Jennifer L Lund; Michele Jonsson Funk
Journal:  Rheumatology (Oxford)       Date:  2020-01-01       Impact factor: 7.580

Review 10.  Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative.

Authors:  J Stephen Mikita; Jules Mitchel; Nicolle M Gatto; John Laschinger; James E Tcheng; Emily P Zeitler; Arlene S Swern; E Dawn Flick; Christopher Dowd; Theodore Lystig; Sara B Calvert
Journal:  Ther Innov Regul Sci       Date:  2020-06-22       Impact factor: 1.778
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