What question did this study set out to answer?

To outline an integrated ethical and scientific framework that promotes the fair and early inclusion of pregnant women in clinical drug research.

January 29, 2018SHILAP Revista de lepidopterologíaOpen Access

Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach

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Authors

RGRieke van der GraafUniversity Medical Center Utrecht IZIndira S. E. van der ZandeUniversity of Groningen HRHester M. den RuijterPreventive Cardiology

Discussion

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Implication

Ethical analysis demonstrates necessary early-phase inclusion in pregnant women, highlighting shared multi-stakeholder responsibility to build safe drug evidence.

Key Points

To outline an integrated ethical and scientific framework that promotes the fair and early inclusion of pregnant women in clinical drug research.
Conceptual bioethical and regulatory policy analysis evaluating standard exclusion practices and drug development pipelines for maternal healthcare.
Recommends the active promotion and design of dedicated clinical trials enrolling pregnant individuals starting at the earliest phases of investigation.
Defines a shared, multi-stakeholder ethical responsibility spanning researchers, review committees, regulatory agencies, pharmaceutical sponsors, and journals to expand the maternal drug evidence base.

Cite This Study

Graaf et al. (2018) studied this question.

synapsesocial.com/papers/69dd4d7927c48be1bb40cc7c https://doi.org/10.1186/s13063-017-2402-9

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Implication

Ethical analysis demonstrates necessary early-phase inclusion in pregnant women, highlighting shared multi-stakeholder responsibility to build safe drug evidence.

Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach

Discussion

Member takes

Implication

Key Points

Cite This Study

Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach

Discussion

Member takes

Implication

Key Points

Cite This Study

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