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that 91% of medications for adults lacked data about the safety and efficacy for pregnant women, or determinations of risk to the fetus. In the case of highly lethal illnesses like Ebola and HIV/AIDS before the development of effective therapies, the exclusion of pregnant women from potentially life-saving clinical therapies results in them being "protected to death".
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As a result of excluding pregnant women from clinical trials, the safety and efficacy of therapies cannot be evaluated for them. Over 80% of pregnant women are regularly prescribed therapies that are untested in pregnant populations. A study of medications approved by the FDA from 1980 to 2010 showed
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cannot give consent to participate in the research. Some clinical research could also result in unexpected harm to the fetus. Other concerns are that pregnant women are potentially more vulnerable to negative side effects than other populations. It has also been hypothesized that pregnant women could
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Several projects and coalitions have formed to promote the inclusion of pregnant women in clinical research. These include the
Coalition to Advance Maternal Therapeutics, which consists of twenty member organizations, and the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies
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generally agree that clinical trials should include pregnant women. Because pregnancy changes the way the body metabolizes drugs, it is otherwise difficult to predict how drugs tested in non-pregnant adults will affect pregnant women. In order to treat illness in pregnant women, clinical research
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or the perception of increased risk to the woman. Excluding pregnant women from research has also been called unethical, as it results in a scarcity of data about how therapies affect pregnant women and their fetuses. Despite consensus from bioethicists, researchers, and regulators that pregnant
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Conversely, the exclusion of pregnant women from clinical research has also been called unethical. The data regarding drug use and pregnancy is scarce and of poor quality. Therefore, pregnant women do not necessarily have the same access to informed, effective healthcare as other populations.
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clinical trials that could have included pregnant women instead excluded them. note that this “review” is not linked to in this article and that is a study about testing during an Ebola outbreak.
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Van Der Graaf, Rieke; Van Der Zande, Indira S. E.; Den
Ruijter, Hester M.; Oudijk, Martijn A.; Van Delden, Johannes J. M.; Oude Rengerink, Katrien; Groenwold, Rolf H. H. (2018).
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women should be included in clinical research, up to 95% of Phase IV clinical trials that could have included pregnant women did not, according to a 2013 review.
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be more susceptible to coercion than non-pregnant adults. There is insufficient data to support either of these two latter concerns, according to a 2020 review.
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concluding that "pregnant women should be presumed to be eligible for participation in biomedical research", a 2013 publication noted that about 95% of
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Heyrana, Katrina; Byers, Heather M.; Stratton, Pamela (2018). "Increasing the
Participation of Pregnant Women in Clinical Trials".
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There are several points of concern regarding clinical research with pregnant women. Some concern is related to the idea that the
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69:. However, the guidelines were interpreted to exclude pregnant women from any clinical trial. Despite a 1994
107:(PREVENT), a project that sought to increase the inclusion of pregnant women in vaccine trials during
202:"Fair inclusion of pregnant women in clinical trials: An integrated scientific and ethical approach"
301:"The Moral Imperative to Include Pregnant Women in Clinical Trials of Interventions for COVID-19"
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65:(FDA) enacted protections to limit reproductive-age women's exposure to
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260:"Ethics of Conducting Clinical Research in an Outbreak Setting"
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Ethical and Legal Issues of
Including Women in Clinical Studies
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Malhamé, Isabelle; d'Souza, Rohan; Cheng, Matthew P. (2020).
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19:have historically been excluded from
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53:Due to complications from the drugs
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121:Children in clinical research
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71:National Academy of Medicine
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305:Annals of Internal Medicine
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264:Annual Review of Virology
219:10.1186/s13063-017-2402-9
360:Clinical research ethics
126:Clinical research ethics
164:10.1001/jama.2018.17716
94:Promoting participation
365:Human subject research
49:Limiting participation
32:Ethical considerations
103:must involve them.
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158:(20): 2077–2078.
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