Ethical issues in therapeutic use and research in pregnant and breastfeeding women

Weld, Ethel D.; Bailey, Theodore C.; Waitt, Catriona

doi:10.1111/bcp.14914

Cited by 39 publications

(24 citation statements)

References 73 publications

(109 reference statements)

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“…The lack of inclusion of pregnant and breastfeeding women in clinical trials also means an inequity of access to newer and potentially more effective and tolerable ARV medications. 33 …”

Section: Background – the Perspective Of Consultants In Sexual Health And Hiv Medicinementioning

confidence: 99%

“…Weld et al 33 describe how through decades of activism, the paradigm in HIV has shifted from ‘a paternalistic framework of protecting women from research to a perspective of protecting women through research’ and how this is particularly relevant with regards to pregnancy. An example of this comes from Fairlie et al , 34 who suggest a step-wise approach to including pregnant women in trials.…”

Section: Background – the Perspective Of Consultants In Sexual Health And Hiv Medicinementioning

confidence: 99%

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From presumptive exclusion towards fair inclusion: perspectives on the involvement of women living with HIV in clinical trials, including stakeholders’ views

Namiba

Kwardem

Dhairyawan

et al. 2022

Therapeutic Advances in Infection

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2journals.sagepub.com/home/tai black women were under-recruited by around 35%. They also found that despite most of the global burden of HIV being in low and low-middle-income countries, most of the trials were carried out in high and high-middle-income countries. A systematicreview 5 of HIV cure research published in 2015 found that women, as well as older people and those of non-white ethnicities were profoundly under-represented.This pattern of under-recruitment is not only seen in HIV, but in many disease areas including cardiovascular disease, 7 cancer, 8 and mental health conditions. 9 Sex and gender differences 10 in the prevalence,incidence, 11 symptomatology, andprogression 12 of a range of diseases have been described, as have differences in responses to treatment. These differences in treatment responses are likely to be attributable to differences in how the body deals with a drug (pharmacokinetics) and the effect of the drug on the body (pharmacodynamics). This may affect the efficacy and tolerability of thedrug. 13 Importantly, sex 14 and gender 15 inequalities 16 in social and economic power also have a large impact on health outcomes, affecting health-seeking behaviour, access to, and utilisation of healthcare services.journals.sagepub.com/home/tai 13Visit SAGE journals online journals.sagepub.com/ home/tai

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“…The lack of inclusion of pregnant and breastfeeding women in clinical trials also means an inequity of access to newer and potentially more effective and tolerable ARV medications. 33 …”

Section: Background – the Perspective Of Consultants In Sexual Health And Hiv Medicinementioning

confidence: 99%

Section: Background – the Perspective Of Consultants In Sexual Health And Hiv Medicinementioning

confidence: 99%

From presumptive exclusion towards fair inclusion: perspectives on the involvement of women living with HIV in clinical trials, including stakeholders’ views

Namiba

Kwardem

Dhairyawan

et al. 2022

Therapeutic Advances in Infection

View full text Add to dashboard Cite

show abstract

“…This evidence base must be established using inclusive research, from the perspective of age, gender, gravidity, ethnicity and morbidity. Specific examples of cases for inclusion are highlighted by Weld et al, 3 Soofi, 4 and Magavern et al 5 The rationale of excluding pregnant women from clinical research is similar to that of excluding dementia patients in that the approach is protectionist. The pregnant women, fetus and dementia patient can be viewed as vulnerable and needing to be protected from research.…”

mentioning

confidence: 99%

“…Therefore, as Weld et al write, this needs to shift to protection through research. 3 Several particularly potent examples of harm are discussed; the withholding of effective HIV therapy due to lack of inclusive research, and the exclusion of women from trials for Ebola, which carried an untreated mortality risk of 80% for pregnant women and even higher risk for the untreated infant. 3 Soofi also outlines options to facilitate rather than exclude dementia patients from research participation.…”

mentioning

confidence: 99%

“…3 Several particularly potent examples of harm are discussed; the withholding of effective HIV therapy due to lack of inclusive research, and the exclusion of women from trials for Ebola, which carried an untreated mortality risk of 80% for pregnant women and even higher risk for the untreated infant. 3 Soofi also outlines options to facilitate rather than exclude dementia patients from research participation. 4 The lack of inclusion of various ethnic groups in genetic research stems from a history of abuse leading to mistrust between establishment science and medicine and minority groups.…”

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confidence: 99%

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Ethics in clinical pharmacology: Facilitating public trust

Magavern

Piasecki

Cohen

et al. 2021

Brit J Clinical Pharma

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The COVID-19 global pandemic setting has highlighted the role of trust in mediating relationships between experts, who design, manufacture, market and prescribe medication, and the lay public, who ingest medication. 1 Ethical interventions in science and medicine are intended to cultivate and preserve trust within the larger community. Therefore, this themed issue revolves around the timely topic of ethics in clinical pharmacology. This is a very broad remit, as reflected in this issue which touches on a number of different aspects of pharmacology, from the inception of a medical problem, to inclusivity in research and clinical trials, the ethical review of research proposals, and priority in vaccine distribution.

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Society for birth defects research and prevention's multidisciplinary research needs workshop 2022: A call to action

Basu

Howdeshell

Rasmussen

et al. 2023

Birth Defects Research

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The Society for Birth Defects Research and Prevention (BDRP) strives to understand and protect against potential hazards to developing embryos, fetuses, children, and adults by bringing together scientific knowledge from diverse fields. The theme of 62nd Annual Meeting of BDRP, “From Bench to Bedside and Back Again”, represented the cutting‐edge research areas of high relevance to public health and significance in the fields of birth defects research and surveillance. The multidisciplinary Research Needs Workshop (RNW) convened at the Annual Meeting continues to identify pressing knowledge gaps and encourage interdisciplinary research initiatives. The multidisciplinary RNW was first introduced at the 2018 annual meeting to provide an opportunity for annual meeting attendees to participate in breakout discussions on emerging topics in birth defects research and to foster collaboration between basic researchers, clinicians, epidemiologists, drug developers, industry partners, funding agencies, and regulators to discuss state‐of‐the‐art methods and innovative projects. Initially, a list of workshop topics was compiled by the RNW planning committee and circulated among the members of BDRP to obtain the most popular topics for the Workshop discussions. Based on the pre‐meeting survey results, the top three discussion topics selected were, A) Inclusion of pregnant and lactating women in clinical trials. When, why, and how? B) Building multidisciplinary teams across disciplines: What cross‐training is needed? And C) Challenges in applications of Artificial Intelligence (AI) and machine learning for risk factor analysis in birth defects research. This report summarizes the key highlights of the RNW workshop and specific topic discussions.

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Ethical issues in therapeutic use and research in pregnant and breastfeeding women

Abstract: Principles of Justice, Autonomy, Beneficence and Non-maleficence underpin the ethical design of clinical trials in pregnant and lactating women.

Cited by 39 publications

References 73 publications

From presumptive exclusion towards fair inclusion: perspectives on the involvement of women living with HIV in clinical trials, including stakeholders’ views

From presumptive exclusion towards fair inclusion: perspectives on the involvement of women living with HIV in clinical trials, including stakeholders’ views

Ethics in clinical pharmacology: Facilitating public trust

Society for birth defects research and prevention's multidisciplinary research needs workshop 2022: A call to action

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