Authored by Melissa E. Daley, Communications & Marketing Manager, CISCRP
Clinical trials are standard common practice in cancer treatment for children, adolescents and young adults (AYA). The RACE (Research to Accelerate Cures and Equity) for Children Act requires that medications that are used to treat adult cancers also be assessed for use in pediatric populations, if certain criteria are met. SMEs from ICON, a global provider of consulting, and outsourced development and commercialization services to pharmaceutical, biotechnology, medical device and government and public health organizations, and Children’s Minnesota shared their experiences treating adolescent and young adult populations in light of the RACE for Children Act in a 15-minute Flash Webinar.
“Pediatric cancer is quite a different clinical area. When a child to young adult is newly diagnosed or has relapsed or refractory cancer, providers first look to clinical trials for recommended treatment,” says Missy Hansen, MSN, APRN, CPNP, CPHON, Pediatric Strategy Liaison, Center for Pediatric Clinical Development, ICON a former nurse practitioner now working in pediatric clinical development. “Even if there isn’t an open trial for the child to be enrolled on, providers will often recommend treatment according to a trial, if that trial is what we know to be the best treatment option for that child’s disease.”
It’s important to provide clear and complete information about clinical research participation to parents, caregivers, and pediatric/AYA patients.
“We have to educate families on what a clinical trial is. A lot of times, when a parent hears the word ‘trial’, they think it’s experimental. It’s really looking at what can give you the best quality of life and event-free survival,” says Lori Ranney, DNP, APRN, CPNP, CPHON, Children’s Minnesota, a nurse practitioner. “We look at the family as a whole, and if it’s appropriate, involve children and AYA populations in the discussion.”
Hospitals and other treatment facilities may also include their child-family-life interdisciplinary teams and social workers to provide additional support and resources.
Children’s Minnesota is a large pediatric oncology institution that also has a well-known referral center. About 90% of eligible patients are treated through participation in clinical trials. Children’s Minnesota works to partner with the four surrounding states – Wisconsin, North Dakota, South Dakota, and Iowa – with the goal of bringing care closer to home for patients.
“The RACE for Children Act is updated legislation that went into effect in the summer of 2020. It specifically targets pediatric cancer. The intent is to get more cancer drugs studied in children, thereby ultimately getting new and improved and aid-proof drugs to the children,” says Missy. The RACE for Children Act expands prior legislation and policies designed to increase the development of pediatric drugs, treatments and therapies and eliminates the orphan exemption for pediatric studies for cancer drugs directed at relevant molecular targets (1).
One way to provide medications and treatments to children, particularly in a rare disease space, where there is a limited number of patients, is to consider that some adolescents may be able to receive similar dosages that adults receive, particularly older adolescents, due to their underlying organ maturation. Taking a patient’s physical maturation into account allows for more adolescents to participate in clinical research, even if they are not yet 18 years old. Minor children (under the age of 18 years old) cannot legally provide informed consent to participate in clinical research. They are asked to provide “assent” or “dissent”, meaning they agree or do not agree to take part. To participate in this process, the child must be mature enough to understand the trial and what it entails. (2)
Children’s Minnesota’s AYA Center tailors care to adolescent’s and young adults’ distinct needs, which can significantly impact outcomes. “We strive to make our AYAs feel individualized,” explains Lori. “We have formed a team of physicians, nurse practitioners, and nurses that focus on AYA patients and their individual needs. The AYA population is a unique one. We want to make sure we are helping them gain independence, by looking at what is important to them, such as friends, school and socialization. We have also formed an AYA support group, where patients go out and do fun activities together, so they can see that there are other people living like them, that can connect to in ways that they can’t necessarily connect to their other friends.”
You can learn more by accessing the webinar recording here. View CISCRP’s library of webinars and podcasts here.
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(2) https://www.cancer.gov/about-cancer/treatment/clinical-trials/patient-safety/childrens-assent
