A model for dissemination and independent analysis of industry data

JAMA

Volumn 306, Issue 14, 2011, Pages 1593-1594

  Krumholz, Harlan M ^a,b   Ross, Joseph S ^a  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b YALE NEW HAVEN HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; ROFECOXIB;

CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CLINICAL RESEARCH; DATA ANALYSIS; DRUG EFFICACY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG RECALL; DRUG SAFETY; FALSE POSITIVE RESULT; FUNDING; HUMAN; INDEPENDENT VARIABLE; INFORMATION DISSEMINATION; NOTE; ORGANIZATION; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROCESS MODEL; PUBLIC-PRIVATE PARTNERSHIP; RESOURCE MANAGEMENT; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; TREATMENT PLANNING; VALIDATION PROCESS;

EID: 80053937620     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2011.1459     Document Type: Note

References (8)

1. Eyding D, Lelgemann M, Grouven U, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010; 341:c4737.
2. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med. 2009; 6(9):e1000144.
3. Marciniak TA. Memorandum: Cardiovascular events in RECORD, NDA 21-071/S035. FDA briefing document, advisory committee meeting for NDA 21071 Avandia (rosiglitazone maleate) table. June 14, 2010; http://www.fda.gov/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs / EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm218491.htm. Accessed September 7, 2011.
4. Ross JS, Madigan D, Konstam MA, Egilman DS, Krumholz HM. Persistence of cardiovascular risk after rofecoxib discontinuation. Arch Intern Med. 2010; 170(22):2035-2036.
5. Lyman GH, Kuderer NM. The strengths and limitations ofmeta-analyses based on aggregate data. BMC Med Res Methodol. 2005;5:14.
6. Kesselheim AS, Avorn J. The role of litigation in defining drug risks. JAMA. 2007; 297(3):308-311. (Pubitemid 46143310)
7. Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance. Arch Intern Med. 2009;169(21):1976-1985.
8. Winslow R. Medtronic funds Yale safety study. Wall Street Journal. August 2, 2011. http://online.wsj.com/article/ SB10001424053111903885604576486553944885000.html. Accessed September 7, 2011.