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Medicines in Pregnancy Forum: Proceedings on Ethical and Legal Considerations

  • Ethics Special Section: Meeting Report
  • Published:
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Abstract

To raise awareness and promote dialogue leading to action, this article provides proceedings on ethical and legal considerations associated with medicine use during pregnancy discussed during the 2014 DIA Medicines and Pregnancy Forum. A key focus of discussion at the forum was “When is it ethically appropriate to include or unethical not to include pregnant patients in clinical studies, and how can ethical barriers be addressed?” Also debated was the question “What are the most appropriate methods to collect and share data on medication use in pregnancy, and what is the best process for sharing such information?” Goals of the forum were to gain participant alignment on answers to these ethical questions, offer rationale for the answers, and provide insight into which stakeholders might be needed to facilitate discussion and action. Participants felt that under the right circumstances, drug research in pregnant women is justified and necessary. Multiple ideas and opinions on the handling of pregnant patients in clinical research, treating pregnant women in clinical practice, and communicating data to physicians and patients are presented.

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Author information

Authors and Affiliations

  1. Lilly Corporate Center, Lilly USA LLC, Indianapolis, IN, 46285, USA

    David B. Clemow PhD

  2. Society for Women’s Health Research, Washington, DC, USA

    Martha R. Nolan JD

  3. DIA, Horsham, PA, USA

    Debra L. Michaels MS, RD, LD & Susan A. Cantrell BS Pharm, RPh

  4. Open Medicine Institute, Mountain View, CA, USA

    Andreas M. Kogelnik MD, PhD

  5. UCB, Brussels, Belgium

    Lode Dewulf MD, DPM, FFPM

Authors
  1. David B. Clemow PhD
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  2. Martha R. Nolan JD
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  3. Debra L. Michaels MS, RD, LD
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  4. Andreas M. Kogelnik MD, PhD
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  5. Susan A. Cantrell BS Pharm, RPh
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  6. Lode Dewulf MD, DPM, FFPM
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Corresponding author

Correspondence to David B. Clemow PhD.

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Clemow, D.B., Nolan, M.R., Michaels, D.L. et al. Medicines in Pregnancy Forum: Proceedings on Ethical and Legal Considerations. Ther Innov Regul Sci 49, 326–332 (2015). https://doi.org/10.1177/2168479015572373

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  • DOI: https://doi.org/10.1177/2168479015572373

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