Literature DB >> 28738116

Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices.

Sanket S Dhruva1,2,3, Carolyn M Mazure4,5, Joseph S Ross1,6,7,8,9, Rita F Redberg10,11,12.   

Abstract

Mesh：

Year:  2017        PMID： 28738116      PMCID： PMC5818834          DOI： 10.1001/jamainternmed.2017.3148

Source DB:  PubMed          Journal:  JAMA Intern Med        ISSN： 2168-6106            Impact factor:   21.873


× No keyword cloud information.
  4 in total

Review 1.  Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices.

Authors:  Sanket S Dhruva; Lisa A Bero; Rita F Redberg
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2011-03-01

2.  Representation of blacks, women, and the very elderly (aged > or = 80) in 28 major randomized clinical trials.

Authors:  W D Hall
Journal:  Ethn Dis       Date:  1999       Impact factor: 1.847

3.  Sex based subgroup differences in randomized controlled trials: empirical evidence from Cochrane meta-analyses.

Authors:  Joshua D Wallach; Patrick G Sullivan; John F Trepanowski; Ewout W Steyerberg; John P A Ioannidis
Journal:  BMJ       Date:  2016-11-24

4.  Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals.

Authors:  Nicholas S Downing; Nilay D Shah; Joseph H Neiman; Jenerius A Aminawung; Harlan M Krumholz; Joseph S Ross
Journal:  Trials       Date:  2016-04-14       Impact factor: 2.279
  4 in total
  5 in total

1.  Ensuring Fairness in Machine Learning to Advance Health Equity.

Authors:  Alvin Rajkomar; Michaela Hardt; Michael D Howell; Greg Corrado; Marshall H Chin
Journal:  Ann Intern Med       Date:  2018-12-04       Impact factor: 25.391

2.  Filling the Regulatory Gap: Potential Role of Institutional Review Boards in Promoting Consideration of Sex as a Biological Variable.

Authors:  Korrina A Duffy; Tracy A Ziolek; C Neill Epperson
Journal:  J Womens Health (Larchmt)       Date:  2020-04-08       Impact factor: 2.681

3.  Omitted Affiliation and Disclaimer.

Authors: 
Journal:  JAMA Intern Med       Date:  2017-09-01       Impact factor: 21.873

4.  Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?

Authors:  Stephanie R Fox-Rawlings; Laura B Gottschalk; Laurén A Doamekpor; Diana M Zuckerman
Journal:  Milbank Q       Date:  2018-09       Impact factor: 4.911

5.  Demographic Characteristics of Participants in Trials Essential to US Food and Drug Administration Vaccine Approvals, 2010-2020.

Authors:  Audrey D Zhang; Jeremy Puthumana; Alexander C Egilman; Jason L Schwartz; Joseph S Ross
Journal:  J Gen Intern Med       Date:  2021-03-03       Impact factor: 5.128
  5 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.