Performing research in pregnancy: Challenges and perspectives.

Abstract:

:There are numerous barriers to conducting clinical research in pregnancy, including ethical considerations, logistical difficulties, and federal regulations. Due to these challenges, there is a paucity of data on the safe and appropriate use of dermatologic therapies in pregnancy, even for easily accessed over-the-counter topical products, as well as for commonly prescribed medications. Given the lack of human safety data, the Food and Drug Administration pregnancy labeling system previously placed a high priority on animal data but was recently revised to highlight human data and pregnancy registries. The latter can provide prospective observational data on medication use in pregnant women, while avoiding many of the pitfalls of conducting clinical trials in this population; nevertheless, registry enrollment for dermatologic drugs remains low. Dermatologists must increase awareness of pregnancy registries and encourage patient enrollment to close this knowledge gap.

journal_name

Clin Dermatol

journal_title

Clinics in dermatology

authors

Hartman RI,Kimball AB

doi

10.1016/j.clindermatol.2016.02.014

subject

Has Abstract

pub_date

2016-05-01 00:00:00

pages

410-5

issue

3

eissn

0738-081X

issn

1879-1131

pii

S0738-081X(16)30029-3

journal_volume

34

pub_type

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