Mitigating the impact of disasters and emergencies on clinical trials site conduct: A site perspective following major and minor unforeseen events

Lunt, Helen; Heenan, Helen

doi:10.1016/j.conctc.2019.100487

Cited by 9 publications

(8 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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%

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

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

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

View full text Add to dashboard Cite

show abstract

“…Although there are multiple publications about generic emergency preparedness in health settings, there is minimal information focusing on clinical trial sites [16,17] and we provide recommendations on this respect (Fig. 1).…”

Section: Discussionmentioning

confidence: 99%

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)

et al. 2020

View full text Add to dashboard Cite

Purpose The COVID-19 pandemic has forced healthcare stakeholders towards challenging decisions. We analyse the impact of the pandemic on the conduct of phase I-II trials for paediatric cancer during the first month of state of alarm in Spain. Methods A questionnaire was sent to all five ITCC-accredited Spanish Paediatric Oncology Early Phase Clinical Trial Units, including questions about impact on staff activities, recruitment, patient care, supply of investigational products, and legal aspects. Results All units suffered personnel shortages and difficulties in enrolling patients, treatment continuity, or performing trial assessments. Monitoring activity was frequently postponed (73%), and 49% of ongoing trials interrupted recruitment. Only two patients could be recruited during this period (75% reduction in the expected rate). Conclusions The COVID-19 crisis has significantly impacted clinical research practice and access to innovation for children with cancer. Structural and functional changes are under way to better cope with the expected future restrictions.

show abstract

Section: Discussionmentioning

confidence: 99%

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

Verdú‐Amorós

Hladun

et al. 2020

Preprint

View full text Add to dashboard Cite

Purpose: The COVID-19 pandemic has forced healthcare stakeholders towards challenging decisions. We analyse the impact of the pandemic on the conduct of phase I-II trials for paediatric cancer during the first month of state of alarm in Spain.Methods: A questionnaire was sent to all five ITCC-accredited Spanish Paediatric Oncology Early-Phase Clinical Trial Units, including questions about impact on staff activities, recruitment, patient care, supply of investigational products and legal aspects.Results: All units suffered personnel shortages and difficulties in enrolling patients, treatment continuity or performing trial assessments. Monitoring activity was frequently postponed (73%), and 49% of on-going trials interrupted recruitment. Only two patients could be recruited during this period (75% reduction in the expected rate).Conclusions: The COVID-19 crisis has significantly impacted clinical research practice and access to innovation for children with cancer. Structural and functional changes are under way to better cope with the expected future restrictions.

show abstract

Mitigating the impact of disasters and emergencies on clinical trials site conduct: A site perspective following major and minor unforeseen events

Cited by 9 publications

References 9 publications

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

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

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)

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)

Contact Info

Product

Resources

About