Inclusion of demographic-specific information in studies supporting US Food & Drug Administration approval of high-risk medical devices

JAMA Internal Medicine

Volumn 177, Issue 9, 2017, Pages 1390-1391

  Dhruva, Sanket S ^a,b   Mazure, Carolyn M ^a   Ross, Joseph S ^a,c,d   Redberg, Rita F ^e  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b VA CONNECTICUT HEALTHCARE SYSTEM   (United States)

^c YALE UNIVERSITY   (United States)

^d YALE NEW HAVEN HOSPITAL   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGE; DEMOGRAPHY; DEVICE APPROVAL; DEVICE SAFETY; ETHNIC DIFFERENCE; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; LETTER; MALE; MEDICAL DEVICE; MEDICAL DEVICE REGULATION; MIDDLE AGED; PRIORITY JOURNAL; RACE DIFFERENCE; SEX DIFFERENCE; THERAPY EFFECT; UNITED STATES; LEGISLATION AND JURISPRUDENCE; STATISTICS AND NUMERICAL DATA;

DEMOGRAPHY; DEVICE APPROVAL; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85029052676     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2017.3148     Document Type: Letter

References (6)

1. Dhruva SS, Bero LA, Redberg RF. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes. 2011; 4(2): 165-171.
2. Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals. Trials. 2016; 17: 199.
3. Hall WD. Representation of blacks, women, and the very elderly (aged > or = 80) in 28 major randomized clinical trials. Ethn Dis. 1999; 9(3): 333-340.
4. US Food & Drug Administration. FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data: August 2014. https://www.fda.gov/downloads/regulatoryinformation/legislation/significantamendmentstothefdcact/fdasia/ucm410474.pdf. Accessed June 5, 2017.
5. US Food & Drug Administration Office of Device Evaluation. Office of Device Evaluation Annual Report for Fiscal Year 1994. Silver Spring, MD: US Food & Drug Administration; 1995.
6. Wallach JD, Sullivan PG, Trepanowski JF, Steyerberg EW, Ioannidis JP. Sex based subgroup differences in randomized controlled trials: Empirical evidence from Cochrane meta-analyses. BMJ. 2016; 355: I5826.