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Cancer Clinical Trial Eligibility Criteria


Generally speaking, children constitute a rather healthy population. However, they are still affected by more or less severe diseases – even some diseases specific to the paediatric population. When looking at the main causes of death in paediatrics, childhood cancer is number one worldwide. There are approximately 300,000 children between 0 and 19 years of age diagnosed with cancer each year. Progress has been made for curing childhood cancer, especially in high-income countries where cure rates of 80% are achieved in specific indications, and even a five-year overall survival rate of 90% in acute lymphoblastic leukaemia (1-3). The main reason for these remarkable advancements is clinical research, including clinical trials. However, even when long-term survival is achieved, many survivors of childhood cancer experience long-term adverse effects as well as growth and developmental impacts from the disease or treatment.

While it is generally not possible to prevent cancer in children, the most effective strategy to reduce the burden of cancer in children is to focus on prompt, correct diagnosis followed by effective therapy. Unfortunately, childhood cancer therapies are limited. More clinical research is needed to develop new, children-adapted, safe, and effective treatments for childhood cancer. Deplorably, almost all cancer trials have a minimum age of eligibility of 18 years, with no scientific or ethical rationale. As a result, children and adolescents are generally excluded from trials for new cancer treatments, even when the treatments target cancers that occur in both adults and children. While there are sometimes paediatric clinical trials of novel cancer therapies, these trials are usually conducted several years after drug approval in adults, or not at all.

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Dr Martine Dehlinger-Kremer, PhD, MS, is Vice President of Scientific Affairs, Pediatric Subject Matter Expert, Center for Pediatric Clinical Development, PRA Health Sciences. Dr Dehlinger-Kremer’s expertise spans 30+ years in the research industry, including 29 years of experience in global regulatory affairs, medical affairs, and paediatric leadership. Prior to joining PRA, she served in several executive leadership roles at global CROs and has experience in global drug development in more than 40 countries.

Dr Mark Sorrentino, MD, Vice President, Center for Pediatric Clinical Development,PRA Health Sciences, has 20 years of experience in the pharmaceutical and biotech industries. Prior to joining PRA, he spent five years as the global chair and founder of the paediatric practice area at a leading CRO. In addition to working at CROs, Dr Sorrentino has served as the global chief medical officer at ADMA Biologics and as director of medical science at MedImmune.
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