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

Authors :
Clemow, David B.
Dewulf, Lode
Michaels, Debra L.
Nolan, Martha R.
Cantrell, Susan A.
Kogelnik, Andreas M.
Koren, Gideon
Mikita, J. Stephen
Source :
Therapeutic Innovation and Regulatory Science; March 2014, Vol. 48 Issue: 2 p145-154, 10p
Publication Year :
2014

Abstract

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.

Details

Language :
English
ISSN :
21684790 and 21684804
Volume :
48
Issue :
2
Database :
Supplemental Index
Journal :
Therapeutic Innovation and Regulatory Science
Publication Type :
Periodical
Accession number :
ejs42163746
Full Text :
https://doi.org/10.1177/2168479014522469