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:10.1007/s12094-020-02399-3

Cited by 13 publications

(13 citation statements)

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“…It has also led to a sudden rift in the medical research on diseases other than COVID-19, making the rare disease research more challenging and slower. Numerous experiments and clinical trials have been abandoned, suspended, or post-poned (15,16). Many have paused on their ongoing clinical research to focus on SARS-CoV-2 related research or made substantial modifications to ensure safe clinical care in the hospital.…”

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confidence: 99%

Research and Management of Rare Diseases in the COVID-19 Pandemic Era: Challenges and Countermeasures

Chowdhury

Sium

Anwar

2021

Front. Public Health

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The ongoing coronavirus disease 2019 (COVID-19) pandemic has disrupted every aspect of our life. The need to provide high-level care for an enormous number of patients with COVID-19 infection during this pandemic has impacted resourcing for and restricted the routine care of all non-COVID-19 conditions. Since the beginning of the pandemic, the people living with rare disorders, who represent a marginalized group of the population even in a normal world, have not received enough attention that they deserve. Due to the pandemic situation, they have experienced (and experiencing) an extreme inadequacy of regular clinical services, counseling, and therapies they need, which have made their life more vulnerable and feel more marginalized. Besides, the clinicians, researchers, and scientists working on rare genetic diseases face extra challenges due to the pandemic. Many ongoing research projects and clinical trials for rare and genetic diseases were stalled to avoid patients' and research staff's transmission to COVID-19. Still, with all the odds, telehealth and virtual consultations for rare disease patients have shown hope. The clinical, organizational, and economic challenges faced by institutions, patients, their families, and the caregivers during the pandemic indicate the importance of ensuring continuity of care in managing rare diseases, including adequate diagnostics and priority management strategies for emergencies. In this review, we endeavored to shed light on the issues the rare disease community faces during the pandemic and the adaptations that could help the rare disease community to better sustain in the coming days.

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confidence: 99%

Research and Management of Rare Diseases in the COVID-19 Pandemic Era: Challenges and Countermeasures

Chowdhury

Sium

Anwar

2021

Front. Public Health

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“…Another important key learning from COVID-19 trials has been the need for studies to adapt to emerging internal and external information. 4 , 5 , 9 – 14 It is crucial to do so without undermining the integrity and validity of the study. 15 For regulatory studies, this often means that the type-I-error is strictly controlled, and treatment effects are unbiased.…”

Section: Improving Trial Efficiencymentioning

confidence: 99%

Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group

Ramanan

Modi

Aurich³

et al. 2021

Pediatr Res

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Background The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners. Methods We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity. Findings We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent–patient–public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area.

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“…Although there are multiple publications about the impact of generic emergency situations in health settings [ 30 ],[ 31 ], there is minimal information that focuses specifically on repercussions on paediatric clinical trials sites [ 17 ],[ 18 ]. The American Society of Clinical Oncology (ASCO) recently published an analysis of the impact of COVID-19 on the conduct of oncology clinical trials [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

“…The European Society of Medical Oncology [ 15 ] and international paediatric Oncology Societies [ 16 ] have developed guidelines to mitigate the deleterious effects of the pandemic on the treatment of cancer patients. However, data regarding real-world impact on cancer clinical research during COVID-19 are scarce [ 17 ],[ 18 ].…”

Section: Introductionmentioning

confidence: 99%

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

Rubio‐San‐Simón

André

Cefalo

et al. 2020

European Journal of Cancer

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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.

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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 13 publications

References 14 publications

Research and Management of Rare Diseases in the COVID-19 Pandemic Era: Challenges and Countermeasures

Research and Management of Rare Diseases in the COVID-19 Pandemic Era: Challenges and Countermeasures

Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group

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

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