The forgotten children of clinical research
After attending numerous clinical research conferences in 2019, we were shocked to see just how little diversity was being highlighted as an issue in our industry. Even more disheartened when we realised how little discussion was being had, and how next to nothing is being put into action to rectify the situation. Since then, we’ve put together a white paper to help encourage clinical research teams to be more inclusive and offer guidance on how, ranted a little via numerous blogs, and created factsheets to help drive home the benefits of being more diverse for all. One area that we’ve admittedly not given enough focus though, is the importance of clinical trials for children. So, we’re going to fix that now.
Treating children with the unknown
No one wants to think about a child living with an illness. But the reality is, it’s really important that those in the clinical research industry in particular, do. The situation we find ourselves in right now is this: only around 50% of drugs approved by the FDA have been labelled for use in children. That means that doctors routinely treat children with drugs that have been tested in adults and approved for use in adults, but are likely to have not been tested in children. And that’s a problem.
In the same way that males and females, and people of different ethnicities respond differently to drugs, children respond differently to how adults do. So, if drugs used to treat children are only tested on adults how do we even know that:
1. They work
2. They don’t have any adverse side effects.
On top of this, as a child grows, their metabolism changes. So how a drug affects a new-born may be quite different from how it affects an adolescent.
Robert (Skip) Nelson, Deputy Director and Senior Ethicist of the Office of Pediatric Therapeutics at the FDA, says: “The child may have a different susceptibility to side effects over time, even if the dose remains the same. Or we may need to use a different dose to have the same treatment effect. We may think we can predict some of these differences, but we really can’t without studying them.”
Realistically, if drugs haven’t been tested across child populations, there’s simply no way of knowing if they could potentially do more harm than good. Is that a risk we should really be taking?
The World Health Organization explains the importance clearly by stating: Children are a unique population with distinct developmental and physiological differences from adults. Clinical trials in children are essential to develop age-specific, empirically verified therapies and interventions to determine and improve the best medical treatment available.
Why do children feel forgotten about in clinical research?
Well, there was a point where science treated children as simply a smaller version of adults. They were expected to react similarly to adults when given the same drugs. The only amendments possibly made would be that children were prescribed a lower dose or frequency based on weight or height. What that wouldn’t account for is the fact that children’s brains, internal organs, nervous systems and metabolic processes are all incredibly different to adults.
The good news is that we’ve obviously come a long way from that sort of reasoning and now there are clinical trials dedicated to researching the effects of drugs on children. However, as we said, we’ve still got a long way to go to achieve relative equality across all ages.
Important considerations for children as participants
The informed consent and assent process is complex and information heavy. When communicating with anyone, but particularly young people, it’s really important to make the process as engaging, clear and understandable as possible. Of course, with so many regulations and legalities to follow, it’s not a simple job. But it can be done.
Our white paper - Improving the Informed Consent Process for Improved Clinical Trial Recruitment - offers insight into psychology techniques that can enhance your strategy, highlights the biggest issues you may face, and provides guidance on how to create an effective informed consent process. In addition, you can consult our checklist to make sure that any materials you create for your clinical study has the impact it should on your participant population and follows best practice.
The simple truth is that children are underrepresented in clinical research. And with the knowledge and resources that we have today, it’s unacceptable to rely on drugs tested on adults to be the treatment we give to children, too. Especially as we’re fully aware that children’s responses to these treatments aren’t proven to be the same as adults.
So, as the conversation around diversity in clinical research develops, let’s all make sure that we don’t just focus on gender or ethnicity, but involve children too. Even better, let’s turn those conversations into taking action.