Research without results: Inadequate public reporting of clinical trial results

Contemporary Clinical Trials

Volumn 33, Issue 3, 2012, Pages 486-491

  Gopal, Ravi K ^a   Yamashita, Traci E ^a   Prochazka, Allan V ^a  

^a UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

Author keywords

Clinical trials; Food and Drug Administration; Publication bias; Transparency; Trial registries

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); DATA BASE; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; MEDICAL LITERATURE; MEDICAL RESEARCH; PUBLICATION; PUNISHMENT; QUANTITATIVE STUDY;

BIBLIOMETRICS; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; CONFIDENCE INTERVALS; DATA INTERPRETATION, STATISTICAL; DISCLOSURE; GOVERNMENT REGULATION; HUMANS; INFORMATION DISSEMINATION; LOGISTIC MODELS; NATIONAL INSTITUTES OF HEALTH (U.S.); ODDS RATIO; PUBLISHING; RESEARCH DESIGN; STATISTICS, NONPARAMETRIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84858795818     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2012.02.001     Document Type: Article

References (16)

1. Smyth R.M.D., Kirkham J.J., Jacoby A., Altman D.G., Gamble C., Williamson P.R. Frequency and reasons for outcome reporting bias in clinical trial: interviews with trialists. BMJ 2011, 342:c7153.
2. Kirkham J.J., Dwan K.M., Altman D.G., Gamble C., Dodd S., Smyth R., et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ 2010, 340:c365.
3. Chan A.W., Hrobjartsson A., Haahr M.T., Gotzsche P.C., Altman D.G. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004, 291(20):2457-2465.
4. Jüni P., Nartey L., Reichenbach S., Sterchi R., Dieppe P.A., Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004, 364(9450):2021-2029.
5. Turner E.H., Matthews A.M., Linardatos E., Tell R.A., Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008, 358(3):252-260.
6. Rosen C.J. The rosiglitazone story-lessons from an FDA Advisory Committee meeting. N Engl J Med 2007, 357(9):844-846.
7. Food and Drug Administration Modernization Act of 1997: Public law no. 105-115 § 113 2007.
8. Food and Drug Administration Amendments Act of 2007: Public law no. 110-85 § 113 2007.
9. National Library of Medicine. Clinical trials database [Available at], [accessed on November 29, 2010]. http://www.clinicaltrials.gov.
10. Zarin D.A., Tse T. Medicine. Moving toward transparency of clinical trials. Science 2008, 319(5868):1340-1342.
11. Fisher L.D., Van Belle G. Biostatistics: a methodology for the health sciences 1993, Wiley, New York.
12. Zarin D.A., Tse T., Williams R.J. The Clinicaltrials.gov results database-update and key issues. N Engl JMed 2011, 364(9):852-860.
13. Zarin D.A. Clinical trials registry expands. Interview by Bridget M. Kuehn. JAMA 2009, 302(1):22.
14. Ioannidis J.P. Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA 1998, 279(4):281-286.
15. Hopewell S., Clarke M.J., Stewart L., Tierney J. Time to publication for results of clinical trials. Cochrane Database Syst Rev 2007, 18(2).
16. Yarborough M., Sharp R.R. Restoring and preserving trust in biomedical research. Acad Med 2002, 77(1):8-14.