Impact of COVID-19 on pediatric clinical research in France

Flamein, Florence; Gottrand, Frédéric; Patel, Maya; Hankard, R.

doi:10.1503/cmaj.75416

Cited by 2 publications

(3 citation statements)

References 1 publication

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although inclusion of children seems valuable, the extreme heterogeneity of these trials in terms of products, design, inclusion criteria, clinical endpoints and sample sizes calls for caution. 27,28 While providing children access to otherwise unavailable drugs, many trials appear unlikely to yield sufficient data to draw reasonable conclusions about their pharmacokinetics, dosing or safety putting children at risk of toxicities for little discernible benefits for them and the community at large. 29 In addition, while children should not be exposed to unnecessary risk from products that have not shown indication of safety and benefit in adult studies, deferring pediatric medicines evaluation until after completion of late-stage adult trials may delay access to effective treatments and increase children exposure to experimental use of medicines outside clinical trials.…”

Section: Evolving Understanding Of Covid-19 In Children and Implicati...mentioning

confidence: 99%

Section: Current Research Landscape Of Covid-19 Pharmacologic Treatmentsmentioning

confidence: 99%

See 1 more Smart Citation

Pediatric COVID-19 Therapeutics

Morin

Lallemant

Garcia-Prats

et al. 2021

Pediatric Infectious Disease Journal

View full text Add to dashboard Cite

Children, although at lower risk of poor outcomes from COVID-19 relative to adults, still stand to benefit from therapeutic interventions. Understanding of COVID-19 clinical presentation and prognosis in children is essential to optimize therapeutic trials design. This perspective illustrates how to collectively accelerate pediatric COVID-19 therapeutic research and development, based on the experience of the Global Accelerator for Paediatric Formulations.

show abstract

Section: Evolving Understanding Of Covid-19 In Children and Implicati...mentioning

confidence: 99%

Section: Current Research Landscape Of Covid-19 Pharmacologic Treatmentsmentioning

confidence: 99%

Pediatric COVID-19 Therapeutics

Morin

Lallemant

Garcia-Prats

et al. 2021

Pediatric Infectious Disease Journal

View full text Add to dashboard Cite

show abstract

“…Although there have been, for instance, reports in oncology 3 , 4 , 5 (including pediatric oncology 6 , 7 ) there have been none of such extent for the broad field of pediatrics, where recent work includes calls to mitigate the impact on ongoing and future trials. 8 , 9 This is perhaps because children are less directly impacted by the COVID-19 disease. Nonetheless, pediatric clinical research organization has been greatly affected by the pandemic.…”

mentioning

confidence: 99%

Early Impact of Severe Acute Respiratory Syndrome Coronavirus 2 on Pediatric Clinical Research: A Pan-European and Canadian Snapshot in Time

Mantha

Flamein

Turner

et al. 2021

The Journal of Pediatrics

Self Cite

View full text Add to dashboard Cite

Objective To capture the early effects of the SARS-CoV-2 pandemic on pediatric clinical research. Study design Pediatric clinical research networks from 20 countries and 50 of their affiliated research sites completed two surveys over one month from early May to early June 2020. Networks liaised with their affiliated sites and contributed to the interpretation of results through pan-European group discussions. Based on SARS-CoV-2 first detection dates, countries formed one early and one late detecting cluster. We tested the hypothesis that this clustering influenced clinical research. Results Research sites were first impacted by the pandemic in mid-March 2020 (03/16 ±10 days, the same date as lockdown initiation, P = .99). From first impact up until early June, site initiation and feasibility analysis processes were affected for ˃50% of the sites. Staff were redirected to COVID-19 research for 44% of the sites and 75.5% of sites were involved in pediatric COVID-19 research (only 6.3% reported COVID cases in their other pediatric trials). Mitigations were used, but differently between the early and late detecting country clusters and between countries with and without a pediatric COVID-19 research taskforce. Positive effects include the development of teleworking capacities. Conclusions Through this collaborative effort from pediatric research networks, we found that pediatric trials were affected and conducted with a range of unequally applied mitigations across countries during the pandemic. The global impact might be greater than captured. In a context where clinical research is increasingly multinational, this report reveals the importance of collaboration between National Networks.

show abstract

Impact of COVID-19 on pediatric clinical research in France

Cited by 2 publications

References 1 publication

Pediatric COVID-19 Therapeutics

Pediatric COVID-19 Therapeutics

Early Impact of Severe Acute Respiratory Syndrome Coronavirus 2 on Pediatric Clinical Research: A Pan-European and Canadian Snapshot in Time

Contact Info

Product

Resources

About