Performing research in pregnancy: Challenges and perspectives.
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.
Harvard Combined Dermatology Residency Program, Boston, Massachusetts.
Rebecca I
RI
Hartman
Department of Dermatology, Massachusetts General Hospital, 50 Staniford Street, Suite 240, Boston, Massachusetts IŁ. Electronic address: harvardskinstudies@partners.org.
Alexa B
AB
Kimball
D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence* / Q000379:methods; D000068598:Data Accuracy; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D012042:Registries; D012871:Skin Diseases / Q000188:drug therapy*; D014481:United States