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Peter Gill's blog

A recent study in BMJ Open used the newly developed WHO International Clinical Trials Registry Platform (ICTRP) to find out how many current studies recruiting children for drug studies collect pharmacokinetic data.

The findings of the study were shocking: only one-quarter of 1,081 trials studying medicines in children collect pharmacokinetic information. Further, only one-third of the medicines identified as a priority by the European Medicines Agency actually collected data (at the time of the study in 2008).

Well what is pharmacokinetic data and why is it important? Pharmacokinetics refers to the study of external substances after they are ingested in the human body. For example, when you swallow a pill, pharmacokinetics explains how long it takes your body to absorb the medication, how long it takes your body to break it down and how long the drug works for.

When children are given medication, doctors, nurses, pharmacists and patients assume that drugs would not be available for children unless they have been rigorously tested and understood. In fact, the truth is quite different. Off-label (outside the product license) and unlicensed (without a license for use in children) prescription rates in children range from 11-80%. There are significant gaps and inadequacies in research conducted in children.

Children are not just small adults and have different safety and efficacy profiles of medications than adults due to differences in physiology, disease pathophysiology, pharmacokinetics and pharmacodynamics. Even adverse drug reactions occur more frequently in children with off-label prescribed drugs.

This vital problem needs to be addressed at multiple levels and the WHO has taken a lead role. The ICTRP will help to improve awareness and make it easier to access accurate, up-to-date, understandable information about clinical trials in children.

The WHO has also launched the ‘Make medicines child size’ campaign in 2007. Hopefully this will address the lack of child studies worldwide as only 38% of trials in children are conducted outside of North America. Clearly studies conducted on children in the US or UK cannot be directly applied to children in Sub-Saharan Africa or India.

Outside of the WHO, the StaR Child Health initiative was founded to improve the design, conduct, and reporting of paediatric research.

A spoonful of sugar to help the medicine go down is not enough. More is needed to understand drugs in children.

Is there an evidence base for children in primary care?

Peter Gill
Last edited 9th August 2011

A recent article in PlosONE of Cochrane reviews relevant to children in primary care states there is a mismatch between the focus of published research and the clinical activity for children in general practice. Not only in the UK but in a number of countries: Australia, Netherlands, US and the UK.

What’s odd is that in a condition such as asthma despite representing 3-5% of consultations, it is the focus of nearly one-quarter of all reviews. On the other hand, despite the increasing burden of skin conditions which lead to one-quarter of all visits only 7% of reviews were relevant.

Non-drug interventions (such as counseling) are an important part of general practice yet they are virtually non-existent in evidence syntheses and research funding. Over half of the reviews studied drug interventions in children while 69% of all controlled trials in children assess drug products.

Whilst the number of systematic reviews published is skyrocketing (over 2,500 in 2007 alone) there continues to be avoidable waste in the production and reporting of research evidence (read more on cebmblog’s recent post). Yet, there has not been a similar increase in children reviews in primary care. Since 2000, the percentage of reviews on children nearly tripled compared to a much smaller increase in primary care reviews.

Why the mismatch? Likely due to multiple factors: absence of primary trials, lack of author interests, public funding poorly correlates with disease burden, more interventions in certain conditions (such as asthma) than others, lack of additional academic training in child health and lack of an overall map of the evidence.

Despite the reasons the mismatch is clear and needs to be addressed. Further work needs to be done to look at how the reviews inform clinical practice. Improving the evidence base for children in primary care is a no-brainer. So how and who should sort this out? Initial steps should include encouraging Cochrane Review Groups, funders, and other relevant organizations to prioritize topics.

The recently created PROSPERO international register of systematic reviews is a step forward to help minimize waste.

Is there an evidence base for children in primary care? Not yet.

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