A recent study in the journal Pediatrics reported that only 29% of clinical studies in children have been published. This finding reinforces previous studies that there is significant publication bias in paediatric studies. These findings are a cause for serious concern.

What is publication bias? Essentially, it is the selected publication of studies based on the results, such as only publishing studies that demonstrate a drug works while not publishing studies that demonstrate harms.

Publication bias is a serious problem in healthcare and can have a large influence on treatment decisions by only providing limited information. Researchers have demonstrated substantial publication bias in certain areas such as the antidepressant medication reboxetine.

Several initiatives have been spearheaded to help reduce publication bias. The creation of open-access journals have shifted the focus from the importance of the results (as judged by a journal editorial committee) to the methodological rigour by which the study was completed.

But more importantly has been the creation of online trial registries, such as ClinicalTrials.gov launched in 2000. These registries serve as central databases of all the current and on-going clinical studies. Registration is optional, however in 2005 the ICMJE made registration of clinical trials as a pre-requisite of publication. Although this does not represent all journals, it sent a strong message of the importance of registration.

However despite the creation of trial registries, less than half of US based National Institute of Health (i.e. government) funded trials in children were registered on ClinicalTrials.gov. Another important finding was the lack of information included on the registries. One-third of all clinical studies terminated early did not provide any information about why they were stopped. The situation was similar for suspended studies with one quarter not providing information.

Were these studies stopped because of harms? Were the investigators no longer able to recruit children to enroll? Whatever the reason the studies were stopped, this information must be made public.

Registration of all clinical studies involving children must be made mandatory. This is the only way to minimise publication bias and increase the reporting of research. This would create massive industry uproar, but is it ethical to enroll children in a clinical study without having it publicly registered? At a minimum any trial that receives government funded must be registered.

However registration of studies is only one element of the formula. What about the dissemination of the results? Less than 10% of completed studies in children had results posted and publicly available. With the low publication rates of registered studies, and the even lower rate of posting results, how much information is still missing?

Indeed progress has been made to increase the quality and transparency of clinical studies in children but more is needed. We cannot assume that because trial registries exist that they are being used. Complacency must be replaced with compliance. It seems that more often than not, the little ones have the biggest problems.

The recent post on whether Christmas is bad for you inspired further questions on the evidence behind holiday season myths. There is a common misconception that poinsettias (Euphorbia pulcherrima for the botanists) are poisonous. Grandparents tell stories to new parents that they must be vigilant to ensure that children don’t ingest the plant’s leaves.

But what is the evidence?

A study published in 1996 in the American Journal of Emergency Medicine sought to provide an answer. The authors evaluated 849,575 plant exposures reported to the American Association of Poison Control Centers. Poinsettia exposures accounted for 22,793 cases, or nearly 3%, of which nearly all occurred in December and January. Not surprisingly, 94% of poinsettia exposures were in children.

But were they poisonous? No. None were fatal. In fact, only 4% of patients required treatment in a health care facility and fewer than 7% developed toxicity. Most reactions were mild - children that ingested leaves may experience diarrhea and vomiting or have an allergic reaction to the skin.

Poinsettias are not toxic. They don’t stalk family homes waiting for the opportune time to poison children with their attractive red leaves. Children that accidentally ingest poinsettia leaves rarely require treatment. In fact, the real concern is that they may be a choking hazard.

Well what are the real hazards around Christmas time? The Children's Hospital of Philadelphia website highlights the harms that children need to worry about. An unsuspecting culprit took the top spot: alcohol. Alcohol is a serious hazard in children that can lead to major health problems if ingested by children, even in small quantities. Be wary of leaving empty glasses around the house that could break and be ingested by children.

Similar to alcohol if you are in a cold enough climate, windshield washer fluid and antifreeze are serious hazards. The sweet tasting liquid that looks like Kool-Aid can lead to blindness, seizures, heart-rhythm changes and even death if ingested.

Other quintessential botanical Christmas symbols that are poisonous: holly. A handful of berries from the Illex opaca shrub can produce nausea, vomiting, diarrhea and drowsiness in children. The toxicity of kiss causing mistletoe is not supported by the evidence with most cases having a similar outcome as with poinsettia exposure. But with all substances, beware of large amounts.

Be on the look out for disc batteries (coin shaped circular ones) that can be a choking hazard if swallowed. If they become stuck in the esophagus or stomach, they can begin to leak their caustic contents and cause severe burns.

Irrespective of the hazard, most children swallow these objects when they are left unattended. When enjoying the holiday season this year, keep an eye on the curious children putting objects in their mouth and dispel the old urban myths that lack evidence. Happy Holidays.

On the eve of the 20th anniversary of the United Nations Convention on the Rights of the Child, which recognised the right of all children to "the enjoyment of the highest attainable standard of health", the editor of the Lancet Richard Horton was delivering a plenary address at the first summit of StaR Child Health in Amsterdam in 2009. In his address, he stated the:

“Lack of research, poor research, and poorly reported research are violations of children’s human rights.”

Individuals from various disciplines, including the World Health Organisation, the US Food and Drug Administration, and the European Medicines Agency, gathered together to discuss a topic of shared interest: the paucity and shortcomings of paediatric clinical trials.

The quality, quantity and relevance of data involving children are substantially lower than those involving adults. This problem persists despite knowledge that inadequate testing of medication in children may result in harmful or ineffective drugs being offered or beneficial drugs being withheld.

Indeed a systematic review sponsored by the World Health Organisation found that there were few guidelines relevant to the design, conduct and reporting of research in children. Most guidelines only seem to focus on what should be done, failing to address the important issue of how it should be completed.

The mission of StaR Child Health is to improve the design, conduct and reporting of research with children through the development and dissemination of evidence-based standards.

How best to achieve this monumental task? The StaR Child Health group is using a "knowledge to action" process that involves using a systematic process to review the current knowledge base, identify gaps, develop guidance and implementation strategies. An ambitious agenda that is gaining tremendous momentum.

Based the results of a systematic review and survey of key stakeholders, they have identified 10 priority issues. Each issue will be systematically addressed by a standard development group that will produce evidence summaries, identify gaps and develop a dissemination strategy. The priority issues include recruitment and informed consent, risk of bias, sample size, age-specific dosage and administration, safety and global health.

But more guidelines and standards will not change the conduct of trials unless they are implemented. StaR Child Health is leading in knowledge translation by involving multiple stakeholders from the beginning and is working with international partners, such as the GRIP Project, a global research network in paediatrics.

For the quality of health care for children across the world to improve, trials must be conducted that address the complexity of child health and provide reliable evidence-based answers. Now we can be confident that we have a bright StaR illuminating the path forward.