February 2024 SOCRA Source Journal - Journal - Page 6
SELF STUDY
Ethical Considerations for Clinical Investigations
of Medical Products Involving Children
Draft Guidance for Industry, Sponsors, and IRBs
September 2022
SOCRA SELF STUDY
Part 2
IV. APPLICATION OF SUBPART
D TO PEDIATRIC CLINICAL
INVESTIGATIONS
IRBs should consider the
following when determining if
the regulatory criteria for clinical
investigations involving children
have been met.
A. Data to Support
Conducting Pediatric Clinical
Investigations
Multiple sources of information
may be used to inform the
design of an acceptable
pediatric clinical investigation.
Information from nonclinical
studies, bench testing or
modeling and simulation
(especially in the case of
devices), and literature may be
used to assess the potential
risks and benefits of initiating
the investigation in children.
Depending on the quality and
applicability of these data,
collection of relevant adult
data prior to initiation of a trial
6
in pediatric subjects may not
always be necessary. If relevant
adult data are available, those
data may inform the trial design
for pediatric subjects (see
Principle of Scientific Necessity,
section III.A). Early inclusion
of children in medical product
development or initiation of
clinical trials directly in children
may be appropriate. In some
cases, adult studies may not be
ethical or feasible. For example,
for a rare disease with high
pediatric mortality, there may
be few adults with the disease,
or adults may have a less severe
form with limited applicability to
the more severe pediatric form.
B. Design Considerations for
Clinical Investigations
Clinical investigations involving
children should be designed to
maximize the amount of
information gained and
minimize the number of
subjects involved.
SOCRA SOURCE © May 2023
The risks posed by the drug
or device in a pediatric
clinical investigation may vary
depending on
the particular subgroup of
pediatric patients. Factors to
consider when designing a
clinical
investigation and assessing
the potential risks to children
involved in the study include
the:
• Age and degree of
physiological maturity of the
child;
• Nature and natural history of
the clinical condition to be
treated;
• Current severity of the
condition to be treated in
the child;
• Presence of other
complicating clinical
conditions;
• Safety and effectiveness of
the drug or device that may
have been demonstrated