Commentary: Preserving confidentiality of interim data

Clinical Trials

Volumn 12, Issue 1, 2015, Pages 18-20

  Chuang Stein, Christy ^a   Jiang, Qi ^b   Marchenko, Olga ^c  

^a PFIZER INC   (United States)

^b AMGEN INC   (United States)

^c IQVIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARDIOVASCULAR RISK; CONFIDENTIALITY; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG SURVEILLANCE PROGRAM; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; NOTE; PATIENT MONITORING; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PUBLICATION; RESPONSIBILITY; RISK ASSESSMENT; RISK FACTOR; TOTAL QUALITY MANAGEMENT; UNITED STATES; ANONYMIZATION; CLINICAL TRIAL (TOPIC); FEMALE; MALE; ORGANIZATION AND MANAGEMENT; PROCEDURES; PROFESSIONAL STANDARD; STANDARDS;

CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA ANONYMIZATION; FEMALE; HUMANS; MALE;

EID: 84922387452     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774514562032     Document Type: Note

References (2)

1. Chakravarty A, Chuang-Stein C, Jiang Q, et al. Evaluation and review of strategies to assess cardiovascular risk in clinical trials in patients with type 2 diabetes mellitus. Submitted for publication, 2014.
2. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry and investigators. Safety reporting requirements for INDs and BA/BE studies, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm227351.pdf (2012, accessed 27 October 2014).