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The impact of paediatric medical trauma in clinical trials

Up to 80% of children and their families experience paediatric medical trauma after medical interactions or significant illnesses. Patient-centric paediatric clinical trials can help mitigate the risk of potentially life-long implications of medical trauma and improve trial outcomes.

Many children dislike going to the doctor. It can be a stressful experience at best, frightening and traumatic at worst. Children in clinical trials must typically undergo more procedures and engage in clinical activities more often, increasing their exposure to potentially stressful or even traumatising experiences. On this World Children’s Day, we are placing the spotlight on an important challenge in paediatric clinical trials — paediatric medical trauma. 

Paediatric medical trauma is troublingly common, and thanks to the efforts of advocates like those in the Paediatric Medical Trauma Working Group, it is well-documented and mitigation strategies are available. However, there is a stark lack of research on its impact in clinical trials. To ensure safe and effective paediatric clinical trials, we must understand the potential effects of paediatric medical trauma and create strategies that maximise a positive patient experience, mitigate trauma and influence long-term health outcomes.

The Paediatric Medical Trauma Working Group shared their personal and professional insights in a recent panel with ICON's SPACE (Supporting Parents and Carers Everywhere), outlining some of the challenges, potential solutions and the mutual benefit of mitigation strategies for patients and the trial operations. 

What is paediatric medical trauma? 

Paediatric medical traumatic stress is a complex set of psychological and physiological responses exhibited by children and their families in the face of pain, injury, serious illness, medical procedures and invasive or distressing treatment experiences1. The physical, psychological and emotional distress, anxiety and fear can lead to conditions like post-traumatic stress disorder (PTSD), which can profoundly affect a child's quality of life with long-term impact.

The prevalence of paediatric medical trauma is staggering – up to 80% of children and their families experience it after routine medical interactions or during management of severe acute or chronic illnesses. Between 25-30% of cases lead to even more severe outcomes, including intrusive thoughts, nightmares and severe or panic-level anxiety. Such stress disrupts daily functioning, hampers optimal recovery, impacts medical decision-making, and also reduces adherence to recommended medical treatment. These problems compound and result in consequences that can endure throughout the child’s life.

Expert insights on paediatric medical trauma 

ICON's SPACE (Supporting Parents and Carers Everywhere) community group invited members of a dedicated Paediatric Medical Trauma Working Group, comprised of members from varied backgrounds to join a panel discussion for ICON employees to share their personal experiences and insights on paediatric medical trauma in clinical trials. 

The expert panel members included:  

  • Jacqui Whiteway brings more than 18 years experience in clinical research to her current role as Senior Director and Head Pediatric Strategy Liaison in ICON’s Centre for Paediatric Clinical Development (CPCD). Driven by compassionate curiosity from her time as a scientist through working in a CRO environment providing input on hundreds of trials, Jacqui’s passion for paediatric clinical development arises from the need to devise optimal approaches for conducting challenging studies so that we can get safe therapeutics to children sooner.
  • Aaron Horowitz, Co-founder and CEO, Empath Labs: As a child he grew up with human growth hormone deficiency, giving himself shots throughout childhood to grow, through which he developed an immense sense of empathy and desire to support kids who are going through difficult medical treatments. His company creates different kinds of interactive companions that children care for in ways that reflect their own care journey.
  • Cristol Barrett O'Loughlin, Founder and CEO, Angel Aid Cares: Cristol had three older brothers with a fatal rare genetic disease called Hunter syndrome who passed away at 12, 18 and 19 years old. Through this, she gained an intimate understanding of the daily demand and chronic traumatic experience of caregiving in a palliative care environment. Angel Aid provides mental health and wellness tools as well as daily and weekly support groups for caregivers.
  • Melissa J. Hogan, Healthcare attorney, writer and consultant: Melissa’s profession as a healthcare attorney became unexpectedly useful when her youngest son was diagnosed with Hunter Syndrome at age two. The initial flood of positivity at finding a clinical trial for her son ebbed during the demanding first year of the first-in-human trial. Although she didn’t yet have the name for it, her son had experienced medical trauma and she didn’t have the resources to help them through it. To provide resources for other families, she co-authored a book with a leading expert on paediatric medical trauma, called “Afraid of the doctor: Every parent’s guide to preventing and managing medical trauma.”
  • Jana Benesh, Director of Therapeutic Expertise, ICON Center for Rare Diseases: Although a neuroscientist by training, Jana was drawn to clinical development after her young son was diagnosed with a rare neurological disease. Beginning during the years he participated in clinical research, her son experiences ongoing medical trauma from the frequent hospital visits and regular invasive procedures and treatments he receives. At ICON, she uses these personal experiences – and those gained from working with other rare disease families and patient advocacy organisations, and facilitating investigator-initiated and sponsored research programs at clinics – to help design studies that utilise optimal endpoints and limit participation burdens in rare disease clinical research.

Improving paediatric clinical trial design

Paediatric medical trauma has been a proverbial elephant in the room for some time, though it hasn’t yet been addressed in the industry. There is risk of trauma in all paediatric clinical trials for both the paediatric participants and their families. Addressing this risk early, by optimising trial design and protocol development, is the best solution to enhance the participant and family experience and improve clinical trial outcomes. Aaron Horowitz emphasised that mitigating medical trauma in trial design could improve adherence to the protocol, improve retention and ultimately decrease protocol deviations. 

As clinical researchers, the panelists shared that minimising the risk of medical trauma has a multifaceted set of benefits that can improve the mental health and well-being of children and their families with ripple effects that benefit the trials themselves. As Melissa J. Hogan aptly summarised, "There really is an ROI on this and a win-win in terms of knowledge, education and implementation."

Improving paediatric patient experience 

Only now that we are highlighting this “elephant in the room,” can industry directly employ tools and strategies to mitigate paediatric medical trauma in clinical trials. The Paediatric Medical Trauma Working Group shared some of the methods they employ and avenues for further development, including protocol design to identify and mitigate potential trauma, ways to provide support for children during trials and various methods to help families navigate the clinical trial process. Recognising this issue and implementing strategies to mitigate trauma can significantly enhance clinical trial outcomes and the experience for patients and their families. 

As we delve deeper into this uncharted territory, this focus on patient centricity and addressing paediatric medical trauma in clinical trials now promises a brighter, more healthful and empathetic future for all involved while getting safe medicines to children sooner 

 

Partner with ICON to gain deeper insight into your patients’ journey and design more patient-centric clinical trials informed by our experience on more than 399 paediatric trials in the last five years. 

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