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International Clinical Trials
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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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