Response

Clinical Trials

Volumn 12, Issue 1, 2015, Pages 21-23

  Fleming, Thomas R ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; GLUCOSE;

ADVISORY COMMITTEE; CARDIOVASCULAR RISK; CAREGIVER; CONFIDENTIALITY; DECISION MAKING; GLYCEMIC CONTROL; HUMAN; MORBIDITY; MORTALITY; NON INSULIN DEPENDENT DIABETES MELLITUS; NOTE; PRIORITY JOURNAL; RESPONSIBILITY; 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: 84922371646     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774514563356     Document Type: Note

References (8)

1. Nissen S. Commentary: confidentiality of interim trial data: the emerging crisis. Clin Trials 2015; 12: 15-17.
2. London AJ. Commentary: data monitoring confidentiality and FDA transparency. Clin Trials 2015; 12: 12-14.
3. Chuang-Stein C, Jiang Q and Marchenko O. Commentary: preserving confidentiality of interim data. Clin Trials 2015; 12: 18-20.
4. US Code of Federal Regulations FDA Subpart H 21 CFR, Secs. 314.500-314.560, http://cfr.regstoday.com/21 cfr314.aspx#21-CFR-SUBPART-H (accessed 27 November 2014).
5. Food and Drug Administration. Guidance for industry. Diabetes mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf
6. Ellenberg S, Fleming T and DeMets D. Data monitoring committees in clinical trials: a practical perspective. West Sussex: John Wiley & Sons, Ltd, 2002.
7. Fleming TR. Protecting the confidentiality of interim data: addressing current challenges. Clin Trials 2015; 12: 5-11.
8. Fleming TR. Clinical trials: discerning hype from substance. Ann Intern Med 2010; 153: 400-406.