Impact of COVID-19 in paediatric early-phase cancer clinical trials in Europe: A report from the Innovative Therapies for Children with Cancer (ITCC) consortium

Abstract

Introduction Data regarding real-world impact on cancer clinical research during COVID-19 are scarce. We analysed the impact of the COVID-19 pandemic on the conduct of paediatric cancer phase I-II trials in Europe through the experience of the Innovative Therapies for Children with Cancer (ITCC). Methods A survey was sent to all ITCC-accredited Early-Phase Clinical Trial Hospitals including questions about impact on staff activities, recruitment, patient care, supply of investigational products and legal aspects, between 1/March and 30/April/2020. Results Thirty-one out of 53 hospitals from 12 countries participated. Challenges reported included staff constraints (30% drop), reduction in planned monitoring activity (67% drop of site initiation visits and 64% of monitoring visits) and patient recruitment (61% drop compared to 2019). The percentage of phase I, phase II trials and molecular platforms closing to recruitment in at least one site was 48.5%, 61.3% and 64.3%, respectively. Additionally, 26% of sites had restrictions on performing trial assessments due to local contingency plans. Almost half of the units suffered impact upon pending contracts. Most hospitals (65%) are planning on improving organizational and structural changes. Conclusion The study reveals a profound disruption of paediatric cancer early phase clinical research due to the COVID-19 pandemic across Europe. Reported difficulties affected both patient care and monitoring activity. Efforts should be made to reallocate resources to avoid lost opportunities for patients and to allow the continued advancement of oncology research. Identified adaptations to clinical trial procedures may be integrated to increase preparedness of clinical research to futures crises.

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

“…This is in line with site initiation visits cancellation reported by the Innovative Therapies for Children with Cancer consortium. 6 …”

“…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.…”

Managing children with brain tumors during the COVID-19 era: Don’t stop the care!

“…In order to limit the negative impact on patients, the EMA (European Medicines Agency) and many scientific societies have issued recommendations and guidelines in order to support the conduct of clinical trials in this patient setting while continuing to ensure patient safety. Nevertheless, a negative impact has been reported on ongoing and starting studies, especially in recruitment and enrollment, with protocol deviations as patients miss hospital visits as well as delayed data reporting or monitoring activity [29] , [30] .…”

Minimizing the Impact of the COVID-19 Epidemic on Oncology Clinical Trials: Retrospective Study of Beijing Cancer Hospital

“…Participants may no longer be able to visit the hospital to receive treatment [4], resulting in protocol deviations. The regular monitoring and auditing of trials may also be affected [5], leading trials to be postponed or terminated; this in turn can delay marketing of drugs and even lead to the scrapping of development plans for new drugs. Several studies from several countries have reported obvious decreases in the numbers of participants newly enrolled in trials, and many oncology clinical trials were suspended in April 2020 in several countries [6][7][8].…”