British Medical Journal
24 May 2014 (Vol 348, Issue 7959)
http://www.bmj.com/content/348/7959

Editorial
Delayed publication of vaccine trials
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g3259 (Published 16 May 2014)
Christopher W Jones, attending physician1, Timothy F Platts-Mills, assistant professor2
Excerpt
Why are we waiting? Sponsors, authors, and editors all contribute to delays
Among medical interventions to improve human health, vaccination has been and remains one of the most important.1 Given the huge number of deaths from influenza pandemics in recent history, the ability to rapidly develop effective vaccines for new strains of influenza is particularly critical. Making and testing a new influenza vaccine that can be administered to the public takes six months or less.2 For example, the pandemic A/H1N1 2009 influenza strain was first identified in April of 2009; four vaccines were approved by the US Food and Drug Administration in September. After the approval of a vaccine, however, important questions remain regarding dosage, effectiveness, and safety. These questions are best answered by randomized clinical trials, and getting complete results from these trials to policy makers, clinicians, and the general public in a timely manner is essential.
The problems of delayed publication and non-publication of clinical trials have been described in a variety of settings.3 4 5 In this issue of The BMJ, Manzoli and colleagues (doi:10.1136/bmj.g3058) examine delays to publication and non-publication for the vitally important area of vaccine trials.6…

Research
Non-publication and delayed publication of randomized trials on vaccines: survey
BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g3058 (Published 16 May 2014)
Cite this as: BMJ 2014;348:g3058
Lamberto Manzoli, associate professor12, Maria Elena Flacco, resident physician13, Maddalena D’Addario, resident physician45, Lorenzo Capasso, PhD student12, Corrado De Vito, assistant professor6, Carolina Marzuillo, assistant professor6, Paolo Villari, professor6, John P A Ioannidis, professor78
Accepted 24 April 2014
Abstract
Objective
To evaluate the extent of non-publication or delayed publication of registered randomized trials on vaccines, and to investigate potential determinants of delay to publication.
Design
Survey.
Data sources
Trials registry websites, Scopus, PubMed, Google.
Study selection
Randomized controlled trials evaluating the safety or the efficacy or immunogenicity of human papillomavirus (HPV), pandemic A/H1N1 2009 influenza, and meningococcal, pneumococcal, and rotavirus vaccines that were registered in ClinicalTrials.gov, Current Controlled Trials, WHO International Clinical Trials Registry Platform, Clinical Study Register, or Indian, Australian-New Zealand, and Chinese trial registries in 2006-12. Electronic databases were searched up to February 2014 to identify published manuscripts containing trial results. These were reviewed and classified as positive, mixed, or negative. We also reviewed the results available in ClinicalTrials.gov.
Main outcome measures
Publication status of trial results and time from completion to publication in peer reviewed journals.
Data synthesis
Cox proportional hazards regression was used to evaluate potential predictors of publication delay.
Results
We analysed 384 trials (85% sponsored by industry). Of 355 trials (404,758 participants) that were completed, 176 (n=151,379) had been published in peer reviewed journals. Another 42 trials (total sample 62 \,765) remained unpublished but reported results in ClinicalTrials.gov. The proportion of trials published 12, 24, 36, and 48 months after completion was 12%, 29%, 53%, and 73%, respectively. Including results posted in ClinicalTrials.gov, 48 months after study completion results were available for 82% of the trials and 90% of the participants. Delay to publication between non-industry and industry sponsored trials did not differ, but non-industry sponsored trials were 4.42-fold (P=0.008) more likely to report negative or mixed findings. Negative results were reported by only 2% of the published trials.
Conclusions
Most vaccine trials are published eventually or the results posted in ClinicalTrials.gov, but delays to publication of several years are common. Actions should focus on the timely dissemination of data from vaccine trials to the public.