Abstract:MINI-REVIEW CONFLICT OF INTEREST PH and CW designed the structure for the review, performed the searches and analysed data. PH, CW, PB and KN wrote the manuscript and formulated the ideal study design for PK studies in pregnancy.
“…Therefore, such studies represent a missed opportunity and may yield confusing or contradictory results. 70,71 In any situation where a participant provides consent for their data and samples to be used in research, the investigators have a responsibility to undertake this to the highest possible standards to maximise the understanding of the clinical question. Recognising some of these challenges, the WHO and the IMPAACT study group hosted a 2-day consultation in 2019 to define best practice for pharmacokinetic studies in pregnant and breastfeeding women with HIV, and published guidance on these aspects of study design, sample collection and data analysis.…”
Section: Legislation and Legal Aspectsmentioning
confidence: 99%
“…It is increasingly recognised that datasets should be made findable, accessible, interoperable and reusable to others (FAIR), 84 but increasing awareness of these principles has not yet transformed practice. 71 It is recognised that a cultural shift is required to move towards widespread adoption of the recommendations. Whilst the principles apply to all trials and pharmacokinetic studies, there is particular importance in transparency of data arising from populations who are rare or difficult to recruit and where the research is believed to have involved some degree of risk.…”
Section: Collaboration Data Sharing and Reusabilitymentioning
“…Therefore, such studies represent a missed opportunity and may yield confusing or contradictory results. 70,71 In any situation where a participant provides consent for their data and samples to be used in research, the investigators have a responsibility to undertake this to the highest possible standards to maximise the understanding of the clinical question. Recognising some of these challenges, the WHO and the IMPAACT study group hosted a 2-day consultation in 2019 to define best practice for pharmacokinetic studies in pregnant and breastfeeding women with HIV, and published guidance on these aspects of study design, sample collection and data analysis.…”
Section: Legislation and Legal Aspectsmentioning
confidence: 99%
“…It is increasingly recognised that datasets should be made findable, accessible, interoperable and reusable to others (FAIR), 84 but increasing awareness of these principles has not yet transformed practice. 71 It is recognised that a cultural shift is required to move towards widespread adoption of the recommendations. Whilst the principles apply to all trials and pharmacokinetic studies, there is particular importance in transparency of data arising from populations who are rare or difficult to recruit and where the research is believed to have involved some degree of risk.…”
Section: Collaboration Data Sharing and Reusabilitymentioning
“…In our April themed issue on Therapeutic Innovations in Infectious Diseases , we published the first series of “Special Populations” reviews associated with a specific therapeutic area 21–24 and we are planning to continue this in the upcoming themed issue on Therapeutic Innovations in Neuroscience , scheduled for publication in April 2022.…”
“…A large portion of individuals worldwide who die each year from diarrhoeal disease are children, particularly with underlying malnutrition 9,10 . It is well documented that there are often altered physiological factors that can affect drug pharmacokinetics, leading in many cases to related safety and efficacy concerns in vulnerable populations, such as those with prevalent co‐morbidities, pregnant women, and young children, particularly those with malnutrition 11,12 …”
Section: What Harm Is Caused By This Neglect?mentioning
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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