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The challenges of pediatric clinical trials

It’s well known that pediatric clinical studies are a minefield of error; and this is why pharmaceutical companies everywhere continue to keep their distance. A report published in the British Journal of Clinical Pharmacology found that smaller profit margins, problems with blood sampling, issues with trial recruitment, and other ethical concerns were among the most detrimental hurdles to overcoming the industry-wide issue. With the possibility of research sites effectively running large randomised controlled trials now a near impossibility, pharama’s absence in children’s healthcare has, unfortunately, left its scars. On average, 50–90% of medicines prescribed are ‘off label’ – meaning that they’ve not been tested for their safety and efficacy in children; with this same report finding that up to 90% of newborns in intensive care could be receiving unlicensed or ‘off label’ drugs.

While this problem won’t be solved overnight, or within the space of a single article, it’s absolutely essential that the trial recruitment issues are addressed as they are perhaps the most easily solvable. Here at Citruslabs, we know a thing or two about patient recruitment - with over 3 million happy patients registered on our recruitment databases. Today, we shine a light on the patient engagement problems corroding the clinical trial recruitment process; and provide some solutions in the hope of raising clinical trial enrollment in this area.

Meet the parents

The number one reason behind patient recruitment issues in paediatric clinical studies is a lack of trust by the parent/guardian. With a national health survey published late last year reporting that over half of states in the US have seen declines in the numbers of essential kindergarten vaccinations, it is no surprise that non-mandatory studies have had little interest. So, how are research sites supposed to recruit in an age where some are becoming more and more suspicious of modern medicine?

While the solution is simple, its implementation is more complex. As most would agree, education is paramount to discrediting ignorance - but one well-structured argument is probably not going to convert followers of hearsay into subscribers to the Lancet. This is why going out and meeting with patients and their guardians must be made into an industry-wide initiative.

Research sites must put in the extra effort to ensure the patient-research relationship is founded on solid foundations. Researchers should make connections with their local clinics, nurseries and schools to have parents/guardians familiarise themselves with the concept of clinical research. A recent survey by Clinical Leader estimates that about half of Americans are not aware of clinical studies and the clinical trial process; and, with paediatric studies already facing more internal issues than perhaps any other form, the last thing this type of clinical research needs is a lack of public awareness.

Make it accessible

While in-person meetings are invaluable for making that essential bond, face-to-face contact isn’t really an option right now; leaving the industry with a limited number of solutions. Yet, all is not lost as a lot of these options could bring in a lot of publicity for the industry if used correctly. Take a look at our breakdown of the alternative clinical protocol with the potential to save paediatric research below.

Social media campaigns

Research sites need to advertise their clinical studies in ways that appeal to the general public. Their methods have to feel fresh yet relevant to everyday life. Make sure to market your study online; mobile advertising is fast becoming the most popular way to sell products/services. Social media is also an ideal platform for raising awareness. It’s estimated that 2.56 billion people are on social media worldwide, so making a profile on Facebook or Twitter puts your study among the masses. To find out more about the power of social media and its results on patient engagement, check out our previous article available here.

Digital educational resources

Similar can be said about digital educational resources. Over the lockdown period, more and more children have been using online material to substitute for in-person teaching. Programs like BBC Bitesize have seen increases in usership across the platform. Clinical research recruiters might want to think about hiring digital content creators to produce material targeted at candidates and their guardians. For instance, the National Heart, Lung and Blood Institute runs an infographic-style page on their website that answers a wide range of FAQs in the simplest way possible.

Video-call services

Whether we have been using them to telecommute or keep in touch with shielding loved ones, video call services have truly saved us all over this tough period. With Zoom reporting a leap in usership from 10 million to 200 million over the last 3 months, it would be unwise for research sites to ignore this new method of communication when it comes to modifying their patient recruitment and engagement metrics. Connecting with parents and guardians via video-call technology is a must today. To ensure that research sites get the most out of their meetings, check out our previous article on patient-researcher communication here.

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.

  • Interested in finding out more? Get in touch with us here, and check out our archives for all our top tips and tricks on running successful clinical trials in today's constantly changing industry.

Still a little unsure? Check out what our customers have to say about us here.


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