Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Dec;10(23):8462-8474.
doi: 10.1002/cam4.4356. Epub 2021 Oct 23.

Intercontinental collaboration in clinical trials for children and adolescents with cancer-A systematic review by ACCELERATE

Teresa de Rojas  1 , Andrew J Pearson  1 , Nicole Scobie  2 , Leona Knox  3 , Darshan Wariabharaj  4 , Pamela Kearns  5 , Gilles Vassal  1   6 , Gregory Reaman  7
Affiliations

Intercontinental collaboration in clinical trials for children and adolescents with cancer-A systematic review by ACCELERATE

Teresa de Rojas et al. Cancer Med. 2021 Dec.

Abstract

Background: Since pediatric cancer drug development is a global enterprise, we sought to provide an overview of the landscape of intercontinental clinical trials in pediatric oncology opened over the last decade.

Methods: ClinicalTrials.gov was systematically searched to identify all clinical therapeutic trials which opened between 2010 and 2020 and recruited pediatric patients (<18 years) with cancer.

Results: Over the last 10 years, 295 (8.7%) of 3383 therapeutic pediatric cancer trials were international and 182 (5.4%) were intercontinental. Most intercontinental trials were phase-1 or 2, with 25% late-phase, 65% were sponsored by industry, and North America was involved in 92%. Industry-sponsored proportionally more phase-1 trials than academia (41% vs. 25%); conversely, academia sponsored more phase-2 and late-phase trials (39% and 31% vs. 36% and 21%, respectively) (p = 0.020). North America-Europe collaboration was predominantly industry sponsored as opposed to North America-Oceania and Europe-Oceania collaboration, more frequently academic (p < 0.0001). Most late-phase trials (18/20, 90%) focusing on pediatric malignancies were conducted by academic sponsors and 10 of these were conducted by Children's Oncology Group (COG)/National Cancer Institute in the United States and Oceania. There was no significant increase over time of intercontinental trials and a trend for a reduction in academic trials.

Conclusions: Despite the relative rarity of childhood malignancies, especially within molecular subtypes, only 5.4% of pediatric cancer trials were intercontinental. The number of intercontinental trials remains small, with no significant increase over the last decade. The ACCELERATE International Collaboration Working Group aims to identify existing hurdles and propose solutions to improve intercontinental collaboration in clinical research for the benefit of children and adolescents with cancer.

Keywords: adolescent cancer; childhood cancer; clinical research; clinical trials; drug development; international collaboration; rare diseases.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

FIGURE 1
FIGURE 1
PRISMA flow diagram showing the number of clinical trials identified and the eligibility process. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta‐Analyses
FIGURE 2
FIGURE 2
Location of international trials for (A) mono‐continental trials (n = 113); and (B) intercontinental trials (n = 182). The size of the bubbles shown in the bubble chart at the bottom‐left of each panel is proportional to the number of trials per continent. Of note: Central America has been considered as part of South America for the purposes of this study
FIGURE 3
FIGURE 3
Proportion of intercontinental trials investigating different types of malignancies. (A) Overview of all trials; (B) Hematologic malignancies; (C) Solid malignancies. CNS, central nervous system; GCT, germ cell tumors
FIGURE 4
FIGURE 4
Evolution over time in the number of trials for (A) all international trials (including intercontinental and mono‐continental trials); (B) all intercontinental trials; (C) intercontinental trials with the academic sponsor; (D) intercontinental trials with industry sponsor; (E–J) intercontinental trials by sponsor and phase
See this image and copyright information in PMC

References

    1. Gatta G, Botta L, Rossi S, et al. Childhood cancer survival in Europe 1999–2007: results of EUROCARE‐5—a population‐based study. Lancet Oncol. 2014;15:35‐47. - PubMed
    1. Trama A, Botta L, Foschi R, et al. Survival of European adolescents and young adults diagnosed with cancer in 2000–07: population‐based data from EUROCARE‐5. Lancet Oncol. 2016;17:896‐906. - PubMed
    1. Noone AM, Howlader N, Krapcho M, et al. SEER cancer statistics review, 1975–2015. National Cancer Institute; 2018. Accessed September 3, 2018. https://seer.cancer.gov/csr/1975_2015/
    1. The European Society for Paediatric Oncology : The SIOPE strategic plan; a European Cancer Plan for Children and Adolescents. 1st ed. SIOPE; 2015. Accessed October 15, 2021. https://worldspanmedia.s3‐eu‐west‐1.amazonaws.com/media/siope/PDF/the‐si...
    1. Vassal G, Zwaan CM, Ashley D, et al. New drugs for children and adolescents with cancer: the need for novel development pathways. Lancet Oncol. 2013;14:e117‐e124. - PubMed

Publication types