Commentary: Confidentiality of interim trial data - The emerging crisis

Clinical Trials

Volumn 12, Issue 1, 2015, Pages 15-17

  Nissen, Steven E ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; GLYCOSYLATED HEMOGLOBIN; MURAGLITAZAR; PLACEBO; ROSIGLITAZONE;

CARDIOVASCULAR DISEASE; CONFIDENTIALITY; DIABETES MELLITUS; DRUG APPROVAL; GLUCOSE BLOOD LEVEL; HEALTH CARE POLICY; HUMAN; NOTE; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; 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: 84922343061     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774514561661     Document Type: Note

References (5)

1. Nissen SE, Wolski K and Topol EJ.Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA 2005; 294: 2581-2586.
2. Nissen SE and Wolski K.Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457-2471 (Erratum in N Engl J Med 2007; 357: 100).
3. US Department of Health and Human Services, Food and Drug Administration and Center for Drug Evaluation and Research (CDER). 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
4. Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013; 369: 1317-1326.
5. European Medicines Agency. Publication and access to clinical-trial data. Draft for Public Consideration 24 June 2013, http://www.ema.europa.eu/docs/en-GB/document-library/Other/2013/06/WC500144730.pdf library/Other/2013/06/WC500144730.pdf