Intercontinental collaboration in clinical trials for children and adolescents with cancer—a systematic review by ACCELERATE

Teresa de Rojas*, Andrew J. Pearson, Nicole Scobie, Leona Knox, Darshan Wariabharaj, Pamela Kearns, Gilles Vassal, Gregory Reaman

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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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.

Original languageEnglish
Pages (from-to)8462-8474
Number of pages13
JournalCancer Medicine
Volume10
Issue number23
Early online date23 Oct 2021
DOIs
Publication statusPublished - Dec 2021

Bibliographical note

Funding Information:
This study was supported by the Andrew McDonough B+ Foundation. The authors thank Andrea Demadonna and Michael Vranken for their dedication and support to the activities of the ACCELERATE International Collaboration Working Group, and the Andrew McDonough B+ Foundation for financial support of ACCELERATE. The funding source had no role in study design, collection, analysis, or interpretation of data, or decision to submit results. Members of the ACCELERATE International Collaboration Working Group: Academia: Todd Alonzo, University of Southern California, USA; Andrea Biondi, Universit? degli Studi di Milano-Bicocca, Italy; Kathy Brodeur-Robb, C17 Council, Canada; Teresa de Rojas, ACCELERATE, Belgium; Maryam Fouladi, Nationwide Children?s Hospital, Columbus, USA; Thomas Gross, NIH (National Institute of Health), USA; Stephen Hunger, Children?s Hospital of Philadelphia, USA; Pamela Kearns, National Institute for Health Research (NIHR) Birmingham, UK; Geoff McCowage, Australasian Children's Cancer Trials, Australia; Alberto Pappo, St. Jude Children Research Hospital, USA; Andrew J Pearson, ACCELERATE, Belgium; Martin Schrappe, Klinik Fuer Allgemeine Paediatrie Der Universitaet Kiel, Germany; Maria Grazia Valsecchi, Universita' di Milano Bicocca, Italy; Gilles Vassal, Gustave Roussy Cancer Campus, France; Brenda Weigel, University of Minnesota, USA; Peter Wejbora, Children?s Cancer Institute Australia, Australia; James Whitlock, The Hospital for Sick Children, Canada; Michel Zwaan, Princess Maxima Center, Netherlands. Advocacy: Vickie Buenger, Coalition Against Childhood Cancer (CAC2); Leona Knox, Solving Kids? Cancer UK, UK; Donna Ludwinski, Solving Kids? Cancer, USA; Nicole Scobie, Zo?4life, Switzerland. Industry: Elly Barry, Day One Biopharmaceuticals, USA; Kathleen Neville, Johnson and Johnson, USA; Anjali Sharma, Amgen, USA; Darshan Wariabharaj, Janssen Research & Development, LLC, USA. Regulators: Dominik Karres, European Medicines Agency, Netherlands; Gregory Reaman, Food & Drug Administration, USA.

Publisher Copyright:
© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Keywords

  • adolescent cancer
  • childhood cancer
  • clinical research
  • clinical trials
  • drug development
  • international collaboration
  • rare diseases

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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