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

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

doi:10.22541/au.161668217.75464337/v1

Cited by 12 publications

(17 citation statements)

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“…These 12 recommendations, grounded in ethics, are a resource for stakeholders working to improve care for pregnant people and their offspring through better evidence, and have informed calls for a more inclusive agenda [27,60,61]. Going forward, pharmaceutical companies can use the guidance to inform approaches to study design and research priorities; regulatory agencies can build on the recommendations in developing strategies for improving knowledge about pharmaceuticals in pregnancy; funders and agenda‐setters can cite guidance as they consider investment in and prioritization of research with pregnant people; oversight bodies can use the guidance in formulating a more ethical and inclusive approach to research protections; researchers can highlight recommendations that support important studies.…”

Section: Discussionmentioning

confidence: 99%

Ending the evidence gap for pregnancy, HIV and co‐infections: ethics guidance from the PHASES project

et al. 2021

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Introduction While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co‐infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy‐specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next‐generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co‐infections research. Discussion The 26‐member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics‐centred guidance for advancing timely, responsible HIV/co‐infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug‐related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post‐approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co‐infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. Conclusions There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for – and the promise of – advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.

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Section: Discussionmentioning

confidence: 99%

Ending the evidence gap for pregnancy, HIV and co‐infections: ethics guidance from the PHASES project

et al. 2021

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“…The prescribing advice for IM-CAB/RPV reflects this lack of data in that the regimen should be used only if benefit outweighs the risk and that alternative oral ART should be considered in line with appropriate guidelines [6,7]. The narrative on the inclusion of women in clinical trials has very much shifted to a focus on fair inclusion [17 ▪▪ ] and the concept of protecting women through not from research [18]. However, at the time of writing, the currently recruiting IM-CAB/RPV trials continue to exclude pregnant women and maintain the usual stringent requirements to avoid pregnancy [19].…”

Section: Pregnancymentioning

confidence: 99%

Clinical implementation of long-acting antiretroviral treatment in high-income countries: challenges and advantages

Waters

Sparrowhawk

2022

Current Opinion in HIV and AIDS

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Purpose of reviewLong-acting antiretroviral therapy (LA-ART) brings a paradigm shift to HIV care with injectable cabotegravir/rilpivirine (IM-CAB/RPV) in current or imminent use in several countries. This brings the usual opportunities and challenges of a new therapy, plus requirements to adapt services to reliably deliver injections and ensure patients understand advantages and limitations. We summarise key considerations for implementation in high-income countries.Recent findingsMonthly IM-CAB/RPV is noninferior to oral ART and monthly IM-CAB/RPV to 1-monthly in carefully selected virally suppressed people. The numerically higher virological failure rate on two-monthly IM-CAB/RPV warrants close attention and careful monitoring. Implementation projects report positive experiences for patients and staff, but also barriers. Data is needed in younger people, pregnancy/breastfeeding, and in those with detectable viraemia secondary to suboptimal adherence.SummaryWe highlight a paucity of real-world data and key unanswered questions. Existing data on injection techniques may have implications for training; monitoring of outcomes is crucial to ensure clinical trial results are replicated in real-life. Better understanding of treatment failure, and individualised therapy, is crucial, and it is important to repeat patient preference surveys as new data emerges to ensure decisions are based on the most recent evidence of benefit vs risk.

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“…For our purposes, a “neglected population” is “a population in whom there is insufficient evidence to inform the safe and effective use of medication.” Clinical trials often stipulate stringent eligibility criteria which are not reflective of the real‐life clinical population who require treatment. Many clinical and demographic factors impact on disease burden and drug disposition, and whilst it is increasingly recognized that it is ethically imperative to study drugs in the populations in whom they are to be used, this is rarely the case in practice 16 . An increasing body of work argues for and exemplifies the study of drugs in pregnant and lactating women and their infants, young children, and adolescents, 17,18 but even in these there remains an unacceptable delay between the time of drug licensing and the availability of data to inform safe and effective use in such populations 19 .…”

Section: What Is a Neglected Population?mentioning

confidence: 99%

“…For our purposes, a "neglected population" is "a population in whom there is insufficient evidence to inform the safe and effective use of burden and drug disposition, and whilst it is increasingly recognized that it is ethically imperative to study drugs in the populations in whom they are to be used, this is rarely the case in practice. 16 An increasing body of work argues for and exemplifies the study of drugs in pregnant and lactating women and their infants, young children, and adolescents, 17,18 but even in these there remains an unacceptable delay between the time of drug licensing and the availability of data to inform safe and effective use in such populations. 19 Where intersecting characteristics exist that render an individual "complex"-such as young, malnourished children with malaria or obese or elderly individuals with prevalent co-morbid conditions 20 -clinicians are forced to make a "best guess" as to the appropriate drug treatment for that individual, perhaps leading to segments of the population that are thrice neglected (the next vanguard, once the twice neglected receive their fair due in research).…”

Section: What Is a Neglected Population?mentioning

confidence: 99%

Twice neglected? Neglected diseases in neglected populations

Weld

Waitt

Barnes

et al. 2021

Brit J Clinical Pharma

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It is unfortunately true that clinicians lack the necessary evidence to know how to use medications properly in large sections of the population and do not have optimal treatments to use for many neglected tropical diseases (NTDs). NTDs often disproportionately affect neglected populations that are left out of research efforts, such as children and pregnant women. As reliable access to safe, effective preventives and treatments can break the cycle of poverty, illness, and ensuing debility that further perpetuates poverty, it is of paramount importance to investigate and develop new medicines for neglected populations suffering from NTDs. Furthermore, there is not only a need to develop and evaluate novel therapies, but also to ensure that these are affordable, available, and adapted to the communities who need them. The NIH has proposed a "4 C's" framework which is relevant for neglected diseases and populations and should be leveraged for the study of the Twice Neglected: Consider inclusion; Collect data from neglected populations with neglected conditions; Characterize differences through meaningful analysis; Communicate findings pertaining to neglected diseases and populations. With this editorial, the British Journal of Clinical Pharmacology hereby launches a call for high-quality articles focusing on NTDs in special populations, to facilitate and encourage the reversal of this dual neglect.

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

Cited by 12 publications

References 0 publications

Ending the evidence gap for pregnancy, HIV and co‐infections: ethics guidance from the PHASES project

Ending the evidence gap for pregnancy, HIV and co‐infections: ethics guidance from the PHASES project

Clinical implementation of long-acting antiretroviral treatment in high-income countries: challenges and advantages

Twice neglected? Neglected diseases in neglected populations

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