TY - JOUR
T1 - Clinical Data for Informed Medication Use in Pregnancy
T2 - Strengths, Limitations, Gaps, and a Need to Continue Moving Forward
AU - Clemow, David B.
AU - Dewulf, Lode
AU - Koren, Gideon
AU - Mikita, J. Stephen
AU - Nolan, Martha R.
AU - Michaels, Debra L.
AU - Cantrell, Susan A.
AU - Kogelnik, Andreas M.
N1 - Funding Information:
One collaboration effort focused on the safety of medication use in pregnancy is EUROmediCAT. This partnership is comprised of several academic centers and governmental registries, with financial support provided by the EU under the 7th Framework Program. Its aim is to build a European central database and associated software system for reproductive safety postmarketing evaluation for antiepileptics, insulin analogues, antiasthmatics, and antidepressants by combining an existing network of congenital anomaly registers in Europe with existing health care databases that will cover over 3.7 million births from 1995 to 2010. CHICOS, another 7th Framework Program tasked with describing potential mother-child cohorts and registries in Europe, has teamed up with EUROmediCAT. This group’s first report demonstrates the collaborative potential of the project and the need for standardization of data collected, such as stage of pregnancy recruitment, medication dose and timing, and stillbirth or abortion case data collection, as well as data transfer format, data coding and collection, confirmation processes, and follow-up duration.
PY - 2014/3
Y1 - 2014/3
N2 - The objective of this paper is to explore the strengths, weaknesses, gaps, and needs in research on medication use in pregnancy, where opportunities have been bypassed to develop standards and collaborations for collecting data to better understand how medications can impact clinical outcomes in pregnant women and developing fetuses. The availability of existing data and the methods of its capture are reviewed, including registries, claims and health record databases, and meta-analyses. The paper focuses on why these efforts have not fundamentally provided benefit-risk information and clinical treatment algorithms for medication use in pregnant women. Methodological issues, such as lack of standardization and central data collection, are discussed. Common barriers are examined, including a lack of awareness and education, cultural hurdles, collaboration deficiency, and an insufficient development of new data collection methods.
AB - The objective of this paper is to explore the strengths, weaknesses, gaps, and needs in research on medication use in pregnancy, where opportunities have been bypassed to develop standards and collaborations for collecting data to better understand how medications can impact clinical outcomes in pregnant women and developing fetuses. The availability of existing data and the methods of its capture are reviewed, including registries, claims and health record databases, and meta-analyses. The paper focuses on why these efforts have not fundamentally provided benefit-risk information and clinical treatment algorithms for medication use in pregnant women. Methodological issues, such as lack of standardization and central data collection, are discussed. Common barriers are examined, including a lack of awareness and education, cultural hurdles, collaboration deficiency, and an insufficient development of new data collection methods.
KW - data
KW - drug
KW - medication
KW - medicine
KW - pregnancy
KW - pregnant
UR - https://www.scopus.com/pages/publications/84895500792
U2 - 10.1177/2168479014523006
DO - 10.1177/2168479014523006
M3 - ???researchoutput.researchoutputtypes.contributiontojournal.article???
AN - SCOPUS:84895500792
SN - 2168-4790
VL - 48
SP - 134
EP - 144
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
IS - 2
ER -