Challenges in early phase clinical trials for childhood cancer during the COVID-19 pandemic: A report from the New Agents Group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP)

Rubio‐San‐Simón, Alba; Verdú‐Amorós, Jaime; Hladun, Raquel; Ribelles, Antonio Juan; Molero, Mari Carmen; Guerra‐García, Pilar; Pérez‐Martínez, Antonio; Castañeda, Alicia; Cañete, Adela; Rojas, Teresa de; Moreno, Lucas; Bautista, Francisco

doi:10.21203/rs.3.rs-28826/v1

Cited by 2 publications

(3 citation statements)

References 6 publications

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“… 6 , 18 , 19 , 20 , 21 For patients who make it to a treatment centre, the pandemic has created additional obstacles to obtaining quality care, including enrolment in clinical trials. 9 This global survey demonstrates that the effect is larger than previously described in single-region studies, 10 , 11 and is particularly marked in centres located in low-income and middle-income countries. Importantly, the effects of the pandemic on paediatric cancer care are largely independent of the number of COVID-19 cases at either the institution level or the national level.…”

Section: Discussionmentioning

confidence: 62%

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Global effect of the COVID-19 pandemic on paediatric cancer care: a cross-sectional study

Graetz

Agulnik

Ranadive

et al. 2021

The Lancet Child & Adolescent Health

101

143

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Background Although mortality due to COVID-19 has been reportedly low among children with cancer, changes in health-care services due to the pandemic have affected cancer care delivery. This study aimed to assess the effect of the COVID-19 pandemic on childhood cancer care worldwide. Methods A cross-sectional survey was distributed to paediatric oncology providers worldwide from June 22 to Aug 21, 2020, through the St Jude Global Alliance and International Society for Paediatric Oncology listservs and regional networks. The survey included 60 questions to assess institution characteristics, the number of patients diagnosed with COVID-19, disruptions to cancer care (eg, service closures and treatment abandonment), adaptations to care, and resources (including availability of clinical staff and personal protective equipment). Surveys were included for analysis if respondents answered at least two thirds of the items, and the responses were analysed at the institutional level. Findings Responses from 311 health-care professionals at 213 institutions in 79 countries from all WHO regions were included in the analysis. 187 (88%) of 213 centres had the capacity to test for SARS-CoV-2 and a median of two (range 0–350) infections per institutution were reported in children with cancer. 15 (7%) centres reported complete closure of paediatric haematology-oncology services (median 10 days, range 1–75 days). Overall, 2% (5 of 213) of centres were no longer evaluating new cases of suspected cancer, while 43% (90 of 208) of the remaining centers described a decrease in newly diagnosed paediatric cancer cases. 73 (34%) centres reported increased treatment abandonment (ie, failure to initiate cancer therapy or a delay in care of 4 weeks or longer). Changes to cancer care delivery included: reduced surgical care (153 [72%]), blood product shortages (127 [60%]), chemotherapy modifications (121 [57%]), and interruptions to radiotherapy (43 [28%] of 155 institutions that provided radiotherapy before the pandemic). The decreased number of new cancer diagnoses did not vary based on country income status (p=0·14). However, unavailability of chemotherapy agents (p=0·022), treatment abandonment (p<0·0001), and interruptions in radiotherapy (p<0·0001) were more frequent in low-income and middle-income countries than in high-income countries. These findings did not vary based on institutional or national numbers of COVID-19 cases. Hospitals reported using new or adapted checklists (146 [69%] of 213), processes for communication with patients and families (134 [63%]), and guidelines for essential services (119 [56%]) as a result of the pandemic. Interpretation The COVID-19 pandemic has considerably affected paediatric oncology services worldwide, posing substantial disruptions to cancer diagnosis and management, particularly in low-income and middle-income countries. This study emphasises the urgency of an equitably distributed robust glo...

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Section: Discussionmentioning

confidence: 62%

“…Paediatric oncology care is reliant on prompt evaluation and diagnosis, referral to tertiary centres, multidisciplinary subspecialised teams, timely and coordinated multimodal therapy, and access to supportive care, all of which have been affected by this pandemic. 9 , 10 , 11 …”

Section: Introductionmentioning

confidence: 99%

Global effect of the COVID-19 pandemic on paediatric cancer care: a cross-sectional study

Graetz

Agulnik

Ranadive

et al. 2021

The Lancet Child & Adolescent Health

101

143

View full text Add to dashboard Cite

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“…Yet the impact on clinical research 1 , 2 is unclear, even more so that different medical specialties may have been impacted differently. 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.…”

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

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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.

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Challenges in early phase clinical trials for childhood cancer during the COVID-19 pandemic: A report from the New Agents Group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP)

Cited by 2 publications

References 6 publications

Global effect of the COVID-19 pandemic on paediatric cancer care: a cross-sectional study

Global effect of the COVID-19 pandemic on paediatric cancer care: a cross-sectional study

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

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