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Kids, cancer, and clinical research
How to ensure pediatric cancer patients and their families are at the forefront of pediatric cancer research
Alexandra Paúl, MD, Medical Strategy Lead, Pediatric and Rare Disease Center of Excellence
Ali Smyth, PhD, Clinical Scientist, Pediatric and Rare Disease Center of Excellence
Feb 15, 2022

A diagnosis of pediatric cancer can be a heartbreaking journey for children, families, and physicians. Often the best treatment option for a child or adolescent with cancer is a clinical trial. These trials involve the most vulnerable patients, and the experience will shape the rest of their lives.

As we prepare for International Childhood Cancer Day on February 15, we think it is important to discuss what patient-centricity means in these trial designs, and how we can create a more positive experience for patients and their caregivers.

International Childhood Cancer Day is a global collaborative campaign to raise awareness about childhood cancer, and to express support for children and adolescents with cancer, the survivors and their families. A key component of the campaign is the importance of addressing the whole needs of the child.

Beyond the diagnosis

Children and adolescents have complex emotional lives in the best circumstances. When they are navigating cancer, these complexities can be amplified. A child in pain, or a frustrated adolescent may fight against the treatment experience, especially when they know that their outcome is not what it was expected to be.

They may feel scared, hopeless, lonely or resentful about their diagnosis and how, treatment or a trial is pulling them away from their friends and life. They may reject any treatment as a way to regain some of that control.

To make clinical trials as engaging as possible, sponsors need to make the emotional, psychological, cognitive and physical needs of patients’ part of the trial plan. That starts with acknowledging that patients and families possess important insights that can help trial planners build better trials.

Inviting patients and caregivers to provide feedback on trial designs and at key points throughout the trial can help deliver the best possible care and support. It also gives patients back some of the power in what can feel like a powerless experience. Being asked what they need, and responding with respect to their perspective and preferences can make them feel like their voices are being heard.

Tips for creating a patient-centric trial for children:

  1. Look at the experience through the lens of the child. When planning a pediatric cancer trial, sponsors should be cognizant of the age of all eligible patients and how that will affect their priorities and concerns. This can inform the selection of age-related tools (videos, animated figures, graphics) as well as how questions and concerns are addressed. Adapting communication style in materials and site training, and acknowledging their level of understanding according to their age and maturity will lead to a more engaging experience for patients and parents.
  2. Incorporate lessons from past trials. Reviewing data and design decisions from previous trials can help sponsors adopt best practices for treating pediatric cancer populations. It can help them address young patients’ needs, designate realistic endpoints and specific eligibility criteria, and avoid protocol barriers from previous trials.
  3. Provide access to trial information. Patients and families need to know what to expect from a trial when deciding whether to commit. Providing honest, age-appropriate answers, keeping them informed about study related issues, and communicating the benefits (and risks) that can come from trial participation, will ensures they prove that you value their participation and ensure informed consent and assent.
  4. Incorporate patient feedback into trial design. Sponsors and CROs should actively seek out patient and family feedback on what they are looking for in a trial experience, and how that experience can lower their burden and increase their comfort with trial participation. Capturing that feedback and implementing it into study planning and design will result in more patient-centric trials, and demonstrate to patients that their input is valued.
  5. Work with patient advocacy organizations. Patient advocacy organizations are essential partners for sponsors to include in the development of pediatric cancer programs. These groups have close connections with a broad population of patients and families, and insights into their needs, expectations, and frustrations with the research process. While each patient and family’s circumstances will be unique, when sponsors engage these organizations in the trial planning process, they can address the challenges and concerns faced by all potential patients, ensuring a more inclusive trial experience.

RACE for Future

Insights from patients and families have always delivered huge value to pediatric cancer programs. The impact of their voices will become even more significant with the recent revision of the US Food and Drug Administration’s RACE for Children Act (Research to Accelerate Cures and Equity). RACE is intended to expand treatment options for pediatric cancer patients by requiring all new oncology drugs be tested in children as well as adults if the molecular targets are relevant to pediatric cancer. This change will likely lead to more innovative pediatric cancer studies, which could drive further increase in pediatric cancer survivorship.

 

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