Life Sciences Horizons Brochure 2025 - Flipbook - Page 44
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2025 Horizons Life Sciences and Health Care
Clinical trial diversity in the EU: Women in general, and pregnant and
lactating women
Gender equality continues to be a hot topic in the EU,
and significant advancements have been made to
increase the inclusion of women in clinical trials. The
Council for Harmonization of Technical Requirements
for Pharmaceuticals for Human Use (ICH) began
producing gender focused clinical trial guidelines as
far back as the 1990’s. However, it is only comparatively
recently that representation of women in clinical trials
has improved.
The Clinical Trial Regulation (Regulation (EU) No 536/2014, CTR),
which came in to force on 31 January 2022, requires that, unless
otherwise justified, trial subjects must be representative of the
target population for the applicable medicinal product, but there
are no binding metrics in the EU for the inclusion of women, or
subsets of women, in clinical trials. The trial protocol should
include a justification for the gender allocation of subjects and,
if a specific gender group is excluded from or under-represented
in the clinical trial, an explanation of the reasons and justification
for these exclusion criteria.
The European Parliament (“EP”) has raised concerns regarding
the CTR. In 2016, the EP called for the implementation of the CTR
to be evaluated as it does not specify any considerations regarding
women, other than for pregnant and lactating women. In 2023,
members of the EP acknowledged that women are significantly
underrepresented in clinical research, as sex and gender differences
are not a focus in the design and analyses of clinical trials; even for
conditions where women are often disproportionally affected, such
as neurological disorders. Some field experts argue that not having
specific requirements on the proportion of woman trial subjects or
separate sample size calculations for both sexes, is problematic
from a benefit-risk point of view.
The conditions for inclusion of pregnant and lactating women
in clinical trials focus on the care that must be taken to avoid any
adverse impact on the health of the (unborn) child. At the same
time, there is an increasing acknowledgement of the need to
generate data for medicinal products in pregnant and lactating
women. The inclusion of pregnant and lactating women in
clinical trials, provided appropriate safeguards are in place, can be
useful in identifying pregnancy related changes in pharmacokinetics
and/or efficacy essential to provide an appropriate benefit-risk
evaluation. The ICH is working on robust guidance on the
inclusion of pregnant and lactating women in clinical trials
which require an assessment of the potential benefits of the
investigational medicinal product, and of clinical trial
participation of pregnant and lactating women against
the uncertainty and potential risks.
Hein van den Bos
Partner
Amsterdam
Bonella Ramsay
Counsel
London
Julia Mischie
Associate
Amsterdam
Samantha van Dijk
Junior Associate
Amsterdam
