Finding Better Ways to Fill Gaps in Pediatric Health Research

Viergever, Roderik F.; Rademaker, Carin M. A.

doi:10.1542/peds.2013-1207

Cited by 8 publications

(4 citation statements)

References 6 publications

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“…Other studies have made clear that registered clinical trials are dominated by research into non-communicable diseases (80%), less than 20% of trials recruit children, more than 60% are sponsored by universities or hospitals and more than 50% investigate drugs. 15 16 24 …”

Section: Discussionmentioning

confidence: 99%

Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

Viergever

Li²

2015

BMJ Open

175

159

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ObjectivesTo analyse developments (and their causes) in the number and proportion of clinical trials that were registered in different parts of the world after the International Committee of Medical Journal Editors (ICMJE) announced in 2004 that it would require registration of clinical trials as a condition for publication.SettingThe International Clinical Trials Registry Platform (ICTRP).DesignThe ICTRP database was searched for all clinical trials that were registered up to 31 December 2013.ResultsThe ICTRP database contained data on 186 523 interventional clinical trials. The annual number of registered clinical trials increased from 3294 in 2004 to 23 384 in 2013. Relative to the number of clinical trial research publications, the global number of registered clinical trials increased fivefold between 2004 and 2013, rising particularly strongly between 2004 and 2005. In certain regions, especially Asia, the annual number of registered trials increased more gradually and continued to increase up to 2013. In India and Japan, two countries with marked but more gradual increases, these increases only happened after several local measures were implemented that encouraged and enforced registration. In most regions, there was a trend toward trials being registered at local registries.ConclusionsClinical trial registration has greatly improved transparency in clinical trial research. However, these improvements have not taken place equally in all parts of the world. Achieving compliance with registration requires a coalescence of global and local measures, and remains a key challenge in many countries. Poor quality of registered trial data and the inaccessibility of trial protocols, results and participant-level data further undermine the potential benefits of clinical trial registration. National and regional registries and the ICTRP have played a leading role in achieving the successes of trial registration to date and should be supported in addressing these challenges in the future.

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Section: Discussionmentioning

confidence: 99%

Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

Viergever

Li²

2015

BMJ Open

175

159

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“…Globally, 90% of the world's research capacity and funding is focused on 10% of the world's children in high-income countries (HICs). 14 Pediatric hospitalists with additional GH expertise are both needed and well positioned to support clinical research capacity building in LMICs in collaboration with LMIC colleagues and in accordance with local research regulations, including in areas of quality improvement (QI) and implementation science.…”

Section: Introductionmentioning

confidence: 99%

Pediatric Hospital Medicine and Global Health: A Fitting Niche for an Emerging Subspecialty

Haq

Rule

Coria

et al. 2021

The American Journal of Tropical Medicine and Hygiene

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As North American hospitals serve increasingly diverse patient populations, including recent immigrants, refugees, and returned travelers, all pediatric hospitalists (PHs) require foundational competency in global health, and a subset of PHs are carving out niches focused in global health. Pediatric hospitalists are uniquely positioned to collaborate with low- and middle-income country clinicians and child health advocates to improve the health of hospitalized children worldwide. Using the 2018 WHO standards for improving the quality of care for children and adolescents worldwide, we describe how PHs’ skills align closely with what the WHO and others have identified as essential elements to bring high-quality, sustainable care to children in low- and middle-income countries. Furthermore, North American global health hospitalists bring home expertise that reciprocally benefits their home institutions.

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“…Globally, paediatric health and research development has lagged behind health research in adults [1]. Addressing this research gap and conducting studies with children has the potential to lead to innovations in healthcare which can substantially improve their health and quality of life [2].…”

Section: Introductionmentioning

confidence: 99%

How should assent to research be sought in low income settings? Perspectives from parents and children in Southern Malawi

et al. 2019

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Background Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent. However, there remain uncertainties about how to judge when children are ready to give assent and about appropriate assent processes. Malawi does not yet have detailed guidelines on assent. Understanding perspectives among children and their parents can assist in developing contextually-appropriate assent guidance. Methods Qualitative research was conducted with children and parents in three settings in Southern Malawi (low- and high-income urban and rural), to take account of any variations between socioeconomic and cultural contexts. In each setting, interviews were conducted with parents and their children who had participated in paediatric research to understand their experiences of assent and views on appropriate assent practice. Focus groups were also conducted with children and parents, to understand broader social perspectives. Results We found widespread support for involving children in decisions on research participation. Participants identified a range of factors that affect children’s capacity to give assent, including intellectual capacity, emotional development, life experience and cultural norms. Age was often mentioned as a consideration, but deemed an unreliable sole indicator of capacity to assent. In relation to appropriate assent processes, participants emphasised considerations such as supporting effective understanding and minimizing harms. Views on how to achieve these aims varied; for example, there were different ideas about the appropriate order in which to approach children and parents, and about whose decision to respect in the event of disagreement. Conclusions Parents and children agreed about the value of involving children in decisions on research, and about the need to promote children’s decision-making capacity while respecting parents’ interests in children’s welfare. Developing practical guidance that meets these principles is challenging, particularly given the need for flexible approaches that suit different study types, children’s capacities and family environments. Further discussion within the Malawi research and ethics community will help develop contextually-appropriate guidelines.

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Finding Better Ways to Fill Gaps in Pediatric Health Research

Cited by 8 publications

References 6 publications

Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013

Pediatric Hospital Medicine and Global Health: A Fitting Niche for an Emerging Subspecialty

How should assent to research be sought in low income settings? Perspectives from parents and children in Southern Malawi

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