Delayed publication of vaccine trials

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 The authors searched …