How to run clinical trials involving children
The United Nations, in partnership with the World Health Organisation (WHO), signed the Millennium Declaration back in 2000; and 20 years on, 3 and half of these targets have been met (including the halving extreme poverty; the closure of gender disparity in education; and the providing of safe drinking water). At the top of these targets is the reducing global child mortality - a topic of great importance especially over the last 5 months. With the US mortality rate at around 0.06% for this age group, this pandemic has made clear the differences of immunity, compared to their adult counterparts, that may define how young people react to disease and treatment.
Today, we take a look at the key clinical protocol needed to run successful clinical studies concerning children. Remember: never work with children unless you are 100% clear on the particulars of paediatric care, so bare in mind that this guide only covers the essentials. Check out our breakdown below.
Regardless of location, all clinical studies are subject to strict regulation - and clinical trials for children are no different. Trials running under EU regulation will need to submit a Paediatric Investigation Plan to the European Medicine Agency. In the US, the Paediatric Research Equity Act requires clinical trials to carry out a similar assessment, the Paediatric Study Plan (PSP). While they carry different labels, these required reports have a lot in common.
The intent of the PSP is “to assess the safety and effectiveness of a drug/biologic for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the drug or biological product is safe and effective”. A further thing to note is that a company with approval for testing their product on adults, does not have approval for children - which is a common pitfall for research sites everywhere. Safety is paramount and before fda clinical trials can commence these requirements must be met.
When working through your PSP or its equivalent, this is also the perfect time to reach out to potential and/or existing clinical trial sponsors. In fact, the mandatory legislation also encourages sponsors to identify pediatric studies as early as possible in product development to shorten the lengthy application process. Getting in contact with clinical trial sponsors as early as possible is recommended.
Recruiting and engaging
Most paediatric studies recruit candidates at local surgeries, nurseries and schools. On average, 50–90% of medicines prescribed are ‘off label’ – meaning that they’ve not been tested for their safety and efficacy in children. Most of these research sites report issues with trial recruitment as a reason for this cause of action.
Recent research by Bavdekar (2013) shows that multiple detrimental factors are in play when the guardian considers their child’s participation. The factors are as follows:
Parents or guardians fear harm to the child.
Parents may be reluctant to enrol children in research studies that do not offer perceivable immediate benefit.
The childhood population is smaller and healthier than the adult population.
There are complex ethical issues associated with paediatric research studies, including difficulties in gaining consent.
The future of paediatric clinical studies will involve clinical trial recruitment making the key point of contact with parents/guardians. It’s apparent that there doesn’t seem to be a lot of patient confidence among these crucial groups. To rectify this, clinical research recruiters need to hone in on the humanitarian.
According to a recent poll, when it comes to charitable giving, people are often ruled by their hearts, not their heads. On the whole, a more personal narrative is preferred by the public when considering charitable action. A study by The Independent found that a third of respondents were more inclined to give to a cause if it has helped someone close to them. So, when recruiting candidates for paediatric studies, it is wise to be in touch with your emotions and empathize with the individual.
Here at Citruslabs, we've created the ideal patient recruitment dashboard to help any researcher improve their current metrics. With over 3 million patients on record, we ensure research sites are connected to a thoroughly educated and engaged pool of participants; so, it is no wonder why we have such high patient confidence! Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use dashboard is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment starts here.