Literature DB >> 28232726

Accelerating development of scientific evidence for medical products within the existing US regulatory framework.

Rachel E Sherman1, Kathleen M Davies1, Melissa A Robb1, Nina L Hunter1, Robert M Califf1,2.   

Abstract

Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about the optimal use of medical products in real-world practice. Here, we argue that contrary to widespread impressions, existing FDA regulations embody sufficient flexibility to accommodate the emerging tools and methods needed to achieve this goal.

Mesh：

Year:  2017        PMID： 28232726     DOI： 10.1038/nrd.2017.25

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


  4 in total

1.  Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010.

Authors:  Robert M Califf; Deborah A Zarin; Judith M Kramer; Rachel E Sherman; Laura H Aberle; Asba Tasneem
Journal:  JAMA       Date:  2012-05-02       Impact factor: 56.272

2.  Transforming Evidence Generation to Support Health and Health Care Decisions.

Authors:  Robert M Califf; Melissa A Robb; Andrew B Bindman; Josephine P Briggs; Francis S Collins; Patrick H Conway; Trinka S Coster; Francesca E Cunningham; Nancy De Lew; Karen B DeSalvo; Christine Dymek; Victor J Dzau; Rachael L Fleurence; Richard G Frank; J Michael Gaziano; Petra Kaufmann; Michael Lauer; Peter W Marks; J Michael McGinnis; Chesley Richards; Joe V Selby; David J Shulkin; Jeffrey Shuren; Andrew M Slavitt; Scott R Smith; B Vindell Washington; P Jon White; Janet Woodcock; Jonathan Woodson; Rachel E Sherman
Journal:  N Engl J Med       Date:  2016-12-15       Impact factor: 91.245

3.  Real-World Evidence - What Is It and What Can It Tell Us?

Authors:  Rachel E Sherman; Steven A Anderson; Gerald J Dal Pan; Gerry W Gray; Thomas Gross; Nina L Hunter; Lisa LaVange; Danica Marinac-Dabic; Peter W Marks; Melissa A Robb; Jeffrey Shuren; Robert Temple; Janet Woodcock; Lilly Q Yue; Robert M Califf
Journal:  N Engl J Med       Date:  2016-12-08       Impact factor: 91.245

4.  Association of Off-label Drug Use and Adverse Drug Events in an Adult Population.

Authors:  Tewodros Eguale; David L Buckeridge; Aman Verma; Nancy E Winslade; Andrea Benedetti; James A Hanley; Robyn Tamblyn
Journal:  JAMA Intern Med       Date:  2016-01       Impact factor: 21.873
  4 in total
  15 in total

1.  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

2.  Flexibility in the FDA approach to orphan drug development.

Authors:  Nina L Hunter; Gayatri R Rao; Rachel E Sherman
Journal:  Nat Rev Drug Discov       Date:  2017-09-01       Impact factor: 84.694

3.  Identifying outcomes that are important to patients with ocular hypertension or primary open-angle glaucoma: a qualitative interview study.

Authors:  Jimmy T Le; Kareshma Mohanty; Amanda K Bicket; Michelle E Tarver; Malvina Eydelman; Tianjing Li
Journal:  Ophthalmol Glaucoma       Date:  2019-07-31

Review 4.  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

5.  A Sponsor's View on Postmarketing Regulatory Commitments Involving Human Drug Products.

Authors:  Laura McKinley; Milton L Pressler; Mary A Hiatt; William Gregory
Journal:  Clin Pharmacol Ther       Date:  2021-07-12       Impact factor: 6.903

6.  Informing single-arm clinical trials with external controls.

Authors:  Ruthie Davi; Nirosha Mahendraratnam; Arnaub Chatterjee; C Jill Dawson; Rachel Sherman
Journal:  Nat Rev Drug Discov       Date:  2020-12       Impact factor: 112.288

7.  Different Weights of the Evidence-Based Medicine Triad in Regulatory, Health Technology Assessment, and Clinical Decision Making.

Authors:  Evelyn Schlegl; Pierre Ducournau; Jörg Ruof
Journal:  Pharmaceut Med       Date:  2017-07-11

Review 8.  Clinical Trial Generalizability Assessment in the Big Data Era: A Review.

Authors:  Zhe He; Xiang Tang; Xi Yang; Yi Guo; Thomas J George; Neil Charness; Kelsa Bartley Quan Hem; William Hogan; Jiang Bian
Journal:  Clin Transl Sci       Date:  2020-04-10       Impact factor: 4.689

9.  Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality.

Authors:  Rebecca A Miksad; Amy P Abernethy
Journal:  Clin Pharmacol Ther       Date:  2017-12-06       Impact factor: 6.875

Review 10.  Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week.

Authors:  Alexander C Fanaroff; Robert M Califf; Robert A Harrington; Christopher B Granger; John J V McMurray; Manesh R Patel; Deepak L Bhatt; Stephan Windecker; Adrian F Hernandez; C Michael Gibson; John H Alexander; Renato D Lopes
Journal:  J Am Coll Cardiol       Date:  2020-08-04       Impact factor: 24.094
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