@article{fdi:010077069,
  title = {{I}nclusion of pregnant women in antiretroviral drug research : what is needed to move forwards ?},
  author = {{F}airlie, {L}. and {W}aitt, {C}. and {L}ockman, {S}. and {M}oorhouse, {M}. and {A}brams, {E}. {J}. and {C}layden, {P}. and {B}offito, {M}. and {K}hoo, {S}. and {R}ees, {H}. and {C}ournil, {A}mandine and {V}enter, {W}. {F}. and {S}erenata, {C}. and {C}hersich, {M}.},
  editor = {},
  language = {{ENG}},
  abstract = {{I}ntroduction {T}o adequately ascertain drug safety and efficacy, drug trials need to include participants from all groups likely to receive the medication following approval. {P}regnant women, however, are mostly excluded from trials, and women participating are often required to use highly effective contraception and taken off study product (even off study) if they conceive. {T}here is little commercial incentive for including pregnant women in clinical trials, even when preclinical animal and human pharmacokinetic and safety data appear reassuring. {W}ith this conservative approach, large numbers of pregnant women are exposed to drug postlicensing with little known about drug safety and efficacy, and little done to systematically monitor outcomes of pregnancy exposure. {D}iscussion {T}he article focuses on antiretrovirals for treating and preventing {HIV}, and presents potential approaches which could extend to other therapeutic areas, to obtaining adequate and timely data to inform use of these drugs in this population. {M}ost importantly the pregnancy risk profile of investigational agents can be systematically stratified from low to high risk, based on guidelines from regulatory bodies. {T}his stratification can determine the progress through preclinical work with animals and non-pregnant women to opportunistic studies among women who become pregnant on a clinical trial or within routine clinical treatment. {S}tratification can include pregnant women in clinical trials, concurrent with {P}hase {II}/{III} trials in non-pregnant adults, and ultimately to postmarketing surveillance for outcomes in pregnant women and their infants. {E}ach step can be enabled by clear criteria from international and local regulatory bodies on progression through study phases, standardized protocols for collecting relevant data, collaborative data sharing, pregnancy outcomes surveillance systems supported by committed funding for these endeavours. {C}onclusions {A} formalized step-wise approach to including pregnant women in antiretroviral drug research should become the new norm. {S}ystematic implementation of this approach would yield more timely and higher quality pregnancy dosing, safety and efficacy data. {T}hrough more vigorous action, regulatory bodies could responsibly overcome reluctance to include pregnant women in drug trials. {F}unders, researchers and programme implementers need to be galvanized to progressively include pregnant women in research - the use of newer, more effective drugs in women is at stake (349).},
  keywords = {{HIV} ; teratogen ; drug dosing ; maternal health ; child health ; antiretroviral ; pregnancy ; dolutegravir ; birth defects},
  booktitle = {},
  journal = {{J}ournal of the {I}nternational {A}ids {S}ociety},
  volume = {22},
  numero = {9},
  pages = {e25372 [10 p.]},
  year = {2019},
  DOI = {10.1002/jia2.25372},
  URL = {https://www.documentation.ird.fr/hor/fdi:010077069},
}