What should patients be told about noninferiority studies?

JAMA Internal Medicine

Volumn 177, Issue 10, 2017, Pages 1459-1460

  Menikoff, Jerry ^a  

^a U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; NOTE; PATIENT PARTICIPATION; PRIORITY JOURNAL; RESEARCH ETHICS; RISK ASSESSMENT; METHODOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ANTIINFECTIVE AGENT;

ANTI-BACTERIAL AGENTS; HUMANS; INFORMED CONSENT; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 85031330763     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2017.3825     Document Type: Note

References (2)

1. Doshi P, Hur P, Jones M, et al. Informed consent to study purpose in randomized clinical trials of antibiotics, 1991 through 2011 [published online August 21, 2017]. JAMA Intern Med. doi:10.1001 /jamainternmed.2017.3820
2. Food and Drug Administration. Justification of Non-Inferiority Margin for the Treatment of Complicated Skin and Skin Structure Infections; 2002. https://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4394b1-01-FDA.pdf. Accessed July 3, 2017.