Patient participation in paediatric
clinical trials involves the entire family,
which presents unique challenges
for both subjects and researchers.
Logistical challenges on the family, such
as transportation, childcare for other
children, and balancing the substantial
commitments of time and effort, often
result in lengthy recruitment times
and narrower patient populations for
paediatric clinical trials. These same
challenges also make evaluability,
patient retention, and treatment
compliance a struggle.
Fortunately, recent innovations in trial
designs are addressing some of these
barriers to recruitment and participation.
Their new technologies and procedures
help alleviate burdens for the subjects
and their families without compromising
the integrity of clinical trial procedures
or the measurement of endpoints.
The Paediatric Patient Journey
To conceptualise the patient journey in
the paediatric research space, imagine
a parent of three children who agrees to
have one child participate in a clinical
trial. The challenges involved in simply
getting to the clinic may mean excusing
them from school, taking time off work,
scheduling a babysitter for the other two
children, or herding all three children
into the car and finding ways to keep
them entertained while at the clinic.
Families may also face additional
challenges, such as changing
or unstable housing, financial
concerns, unreliable transportation,
and changing phone numbers (1).
These barriers and more can lead to
poor treatment compliance or visit
attendance during the course of the
trial, or even to early withdrawal from
the study
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