A Proposed Framework to Address Needs of Clinical Data for Informed Medication Use in Pregnancy

David B. Clemow, Lode Dewulf, Debra L. Michaels, Martha R. Nolan, Susan A. Cantrell, Andreas M. Kogelnik, Gideon Koren, J. Stephen Mikita

Research output: Contribution to journalArticlepeer-review

6 Scopus citations


The objective of this paper is to communicate a proposed framework for addressing research limitations and communication barriers that contribute to a lack of data for making clinical treatment decisions about medication use in pregnancy. To address this global public health concern, a cross-stakeholder coalition composed of several workstreams is proposed. The intent is to foster collaborative discussion regarding potential solutions to address gaps in communication, engagement, and data generation and collection. Topic areas that require focus include development of awareness initiatives, cultural transformation efforts, collaboration initiatives, research standards, data compilation projects, and new data capture methods. Objectives to aid these efforts are outlined, and collaboration among researchers, regulators, health care providers, and patients is emphasized.

Original languageEnglish
Pages (from-to)145-154
Number of pages10
JournalTherapeutic Innovation and Regulatory Science
Issue number2
StatePublished - Mar 2014
Externally publishedYes


  • data
  • drug
  • fetus
  • medication
  • medicine
  • newborn
  • pregnancy
  • pregnant


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