Publication delay of randomized trials on 2009 influenza a (H1N1) vaccination

PLoS ONE

Volumn 6, Issue 12, 2011, Pages

  Ioannidis, John P A ^a   Manzoli, Lamberto ^b   de Vito, Corrado ^c   D'Addario, Maddalena ^c   Villari, Paolo ^c  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CHIETI   (Italy)

^c SAPIENZA UNIVERSITY OF ROME   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

INFLUENZA VACCINE;

CONFIDENCE INTERVAL; DRUG SAFETY; HAZARD RATIO; HUMAN; IMMUNOGENICITY; INFLUENZA A (H1N1); INFLUENZA VACCINATION; PUBLICATION; PUBLICATION DELAY; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SAMPLE SIZE; SYSTEMATIC REVIEW; ACCESS TO INFORMATION; ARTICLE; INFECTION CONTROL; INFLUENZA VIRUS A H1N1; METABOLISM; METHODOLOGY; PANDEMIC; STATISTICAL MODEL; STATISTICS; TIME; VACCINATION;

ACCESS TO INFORMATION; COMMUNICABLE DISEASE CONTROL; HUMANS; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA VACCINES; MODELS, STATISTICAL; PANDEMICS; PUBLISHING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS; VACCINATION;

EID: 82555175804     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0028346     Document Type: Review

References (28)

1. Leung GM, Nicoll A, (2010) Reflections on pandemic (H1N1) 2009 and the international response. PLoS Med 7: e1000346.
2. Manzoli L, De Vito C, Salanti G, D'Addario M, Villari P, et al. (2011) Meta-analysis of the immunogenicity and tolerability of pandemic influenza A 2009 (H1N1) vaccines. PLoS ONE 6: e24384.
3. European Medicines Agency (2009) Pandemic influenza A(H1N1)v vaccines authorised via the core dossier procedure. Explanatory note on scientific considerations regarding the licensing of pandemic A(H1N1)v vaccines. EMEA/608259/2009 rev. http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/11/WC500007567.pdf (accessed 4 October 2011).
4. PLoS Medicine Editors (2010) Journals, academics, and pandemics. PLoS Med 7: e1000282.
5. Xing W, Hejblum G, Leung GM, Valleron AJ, (2010) Anatomy of the epidemiological literature on the 2003 SARS outbreaks in Hong Kong and Toronto: a time-stratified review. PLoS Med 7: e1000272.
6. Lheritier V, Chapuis F, (2005) Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 331: 19.
7. Dickersin K, Min YI, (1993) NIH clinical trials and publication bias. Online J Curr Clin Trials Doc No 50 [4967 words; 53 paragraphs].
8. Dickersin K, Min YI, Meinert CL, (1992) Factors influencing publication of research results. Follow-up of applications submitted to two institutional review boards. JAMA 267: 374-378.
9. Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR, (1991) Publication bias in clinical research. Lancet 337: 867-872.
10. Ioannidis JP, (1998) Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA 279: 281-286.
11. Krzyzanowska MK, Pintilie M, Tannock IF, (2003) Factors associated with failure to publish large randomized trials presented at an oncology meeting. JAMA 290: 495-501.
12. Stern JM, Simes RJ, (1997) Publication bias: evidence of delayed publication in a cohort study of clinical research projects. BMJ 315: 640-645.
13. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, et al. (2008) Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 3: e3081.
14. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM, (2009) Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 6: e1000144.
15. Young NS, Ioannidis JP, Al-Ubaydli O, (2008) Why current publication practices may distort science. PLoS Med 5: e201.
16. Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, et al. (2009) Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med 361: 2424-2435.
17. Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, et al. (2009) Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med 361: 2405-2413.
18. Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, et al. (2009) A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med 361: 2414-2423.
19. Ioannidis JP, Karassa FB, (2010) The need to consider the wider agenda in systematic reviews and meta-analyses: breadth, timing, and depth of the evidence. BMJ 341: c4875.
20. Liang XF, Li L, Liu DW, Li KL, Wu WD, et al. (2011) Safety of Influenza A (H1N1) Vaccine in Postmarketing Surveillance in China. N Engl J Med 364: 638-647.
21. Jackson LA, Patel SM, Swamy GK, Frey SE, Creech CB, et al. (2011) Immunogenicity of an inactivated monovalent 2009 H1N1 influenza vaccine in pregnant women. J Infect Dis 204: 854-863.
22. López-Macías C, Ferat-Osorio E, Tenorio-Calvo A, Isibasi A, Talavera J, et al. (2011) Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico. Vaccine 29: 7826-7834.
23. Food and Drug Administration (2010) Influenza A (H1N1) 2009 Monovalent. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm (accessed 4 October 2011).
24. European Medicines Agency (2011) Medicines authorised during pandemic. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000251.jsp&murl=menus/special_topics/special_topics.jsp&mid=WC0b01ac05801db932 (accessed 4 October 2011).
25. European Medicines Agency (2011) European public health assessment reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d125&jsenabled=true (accessed 4 October 2011).
26. Rising K, Bacchetti P, Bero L, (2008) Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med 5: e217.
27. Lee K, Bacchetti P, Sim I, (2008) Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med 5: e191.
28. PLoS Currents: Influenza. http://knol.google.com/k/plos-currents-influenza# (accessed October 24, 2011).