Let Kids Be Kids – How DCTs Are Key to Pediatric Clinical Trials

Author: MRN

Any parent (family member, carer, babysitter, teacher) will tell you that when a child’s routine changes, so does their behavior. Whether the child is 6 or 16, when there is disruption in their daily lives, there is stress, anxiety, frustration and very often the lack of ability to express what exactly it is that is upsetting them. When this happens, those closest to them will experience the fallout. It may come in the form of reclusiveness, explosive behaviors or through acting out. This creates additional stressors for parents, carers, teachers, and (if there are) siblings.1,2

One of the greatest disrupters of life, let alone family life, is illness – particularly severe or chronic illness of a child. You may be tempted to think that the younger the child is, the easier it will be for them to adapt – but you try telling a teenager that they may be limited in what they can do. Of course, there is often more than one child to think about as well – if the child has siblings, they will also experience the disruption to daily life. So, what has any of this got to do with pediatric clinical trials?

Well, simply put, it is something that SHOULD BE considered when designing a pediatric clinical study, regardless of the age of children eligible to enroll. The level of disruption to not only the child’s life, but their family life is something that will most likely play a significant role in continued engagement and retention in trials.

Difficulties With Retention In Pediatric Studies

A study of 559 pediatric trials showed that 19% were discontinued early, and for 37% of these trials the most common reason for discontinuation was issues retaining patients.3

Another study found that there were multiple reasons for withdrawal from a study – most of which were due to the impact on the child’s daily life. Things such as too many daily treatments doses, too many hospital visits, and lack of compensation to cover the expenses of parents missing work, and the number potentially traumatic procedures such as frequent blood draws were all major contributing factors to choosing to withdraw from a study.4 And the unspoken factor here is time – everything takes time, time that a child should be spending simply being a child. Playing, learning, making friends – all the things that are essential for a child’s development into a healthy, balanced adults.5

Let Kids Be Kids

The “simple solution” to the identified problems is to find ways to minimize the impact clinical trial participation will have on the child. It’s critical for Sponsors and researchers to look for solutions that allow the family to live as “normal” a life as possible – where parents can go to work, children to school, and adjustments to the family routine is negligible.

There are multiple ways to do this, but all involve a level of decentralization of the trial – in short bringing the trial to the patient in some way or another. Depending on the trial protocol itself, there are numerous ways to do this:

  1. Via Technology Designed for DCTs – whether it’s through wearable devices or online consultations with the study team, in today’s world technology should be considered – especially if the trial does not call for many in-person procedures or administration of the investigational medicinal product (IMP).
  1. Community Sites/Pharmacies – this may require more from the sponsor in terms study set-up. They will need to find and validate suitable research sites in communities where they anticipate enrolment to take place. Alternatively, they can look to use Site Networks, which will remove the heavy lifting behind site selection and site location selection. Further community-focused site networks, such as MRN’s global network, they will be able to provide a number of site solutions, as well as access to a myriad of patient populations.
  1. In-home Healthcare Providers (HCPs) – again, without the use of a solution provider, this may prove to an additional burden for sponsors to manage, especially as pediatric trials will usually require HCPs to have specialist training. The use of a solution provider such as MRN can eliminate this burden. With nearly 20-years’ experience in Home Trial Support, we have access to a network of HCPs, including those with specialist training. Further, a range of procedures can be administered in the home – from health check and assessment to blood draws, centrifugation and IMP delivery and administration.

Depending on the complexity of the trial, it maybe that a combination of the above solutions is the best answer, or at least part of the answer – creating a hybrid trial of traditional hospital visit and community-based/remote solutions.

Ultimately, whichever is best for a successful trial, it should be what is best for the child participating in that trial – creating a situation where sponsors, sites, and families win.

Learn how MRN’s Home Trial Support can support pediatric trials here.

References:

  1. Bocknek E. The Importance of Routines for Kids, Zero to Thrive, https://zerotothrive.org/routines-for-kids/, Last Accessed Mar 2025.
  2. RaisingChildren.net.au. Family routines: how and why they work, https://raisingchildren.net.au/preschoolers/family-life/routines-rituals-rules/family-routines, Last Accessed Mar 2025.
  3. Pica N, Bourgeois F. Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children, Pediatrics. 2016 Sep;138(3):e20160223. doi: 10.1542/peds.2016-0223.
  4. Chiaruttini G, et al. Challenges in Paediatric Clinical Trials: How to Make It Feasible, The Management of Clinical Trials, InTech, June 2018.
  5. Saacs D. Let children be children, Journal of Paediatrics and Child Health 53 (2017) 99–100. doi:10.1111/jpc.13474
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