The changing structure of industry-sponsored clinical research: Pioneering data sharing and transparency

Annals of Internal Medicine

Volumn 158, Issue 12, 2013, Pages 914-915

  Kuntz, Richard E ^a  

^a MEDTRONIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BONE MORPHOGENETIC PROTEIN 2;

CLINICAL RESEARCH; EDITORIAL; HUMAN; LAW SUIT; MEDICAL INFORMATION; PATIENT SAFETY; PRIORITY JOURNAL; PUBLIC HEALTH; SYSTEMATIC REVIEW (TOPIC);

BONE MORPHOGENETIC PROTEIN 2; CONFLICT OF INTEREST; DRUG INDUSTRY; HUMANS; INTERVERTEBRAL DISC DEGENERATION; PUBLICATION BIAS; RECOMBINANT PROTEINS; SPINAL FUSION; TRANSFORMING GROWTH FACTOR BETA;

EID: 84879176717     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-158-12-201306180-00011     Document Type: Editorial

References (10)

1. Ross JS, Krumholz HM. Ushering in a new era of open science through data sharing: the wall must come down. JAMA. 2013;309:1355-6. [PMID: 23508736]
2. Rathi V, Dzara K, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, et al. Sharing of clinical trial data among trialists: a cross sectional survey. BMJ. 2012;345:e7570. [PMID: 23169870]
3. Alsheikh-Ali AA, Qureshi W, Al-Mallah MH, Ioannidis JP. Public availability of published research data in high-impact journals. PLoS One. 2011;6: e24357. [PMID: 21915316]
4. National Academy of Sciences. Sharing Clinical Research Data: Workshop Summary. Institute of Medicine; 2013. Accessed at www.iom.edu/Reports/2013/Sharing-Clinical-Research-Data.aspx on 14 May 2013.
5. Eichler HG, Abadie E, Breckenridge A, Leufkens H, Rasi G. Open clinical trial data for all? A view from regulators. PLoS Med. 2012;9:e1001202. [PMID: 22505851]
6. 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:e1000144. [PMID: 19901971]
7. Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169: 1756-61. [PMID: 19858432]
8. Simmonds MC, Brown JV, Heirs MK, Higgins JP, Mannion RJ, Rodgers MA, et al. Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion. A meta-analysis of individual-participant data. Ann Intern Med. 2013;158:877-89.
9. Fu R, Selph S, McDonagh M, Peterson K, Tiwari A, Chou R, et al. Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion. A systematic review and meta-analysis. Ann Intern Med. 2013;158: 890-902.
10. Zarin D. Benefits of Sharing Clinical Research Data. Presented at the Institute of Medicine Workshop on Sharing Clinical Research Data, Washington, DC, 4 -5 October 2012. Accessed at www.iom.edu/Reports/2013/Sharing-Clinical-Research-Data.aspx on 14 May 2013.