Clinical trials for paediatric cancers under new legislation in the USA

Affiliations

¹ Pediatric Therapeutics and Regulatory Science Initiative, Computational Health Informatics Program, Boston Children's Hospital, Boston, MA 02115, USA; Cancer Innovation and Regulation Initiative, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Division of Urological Surgery, Brigham and Women's Hospital, Boston, MA, USA.
² Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
³ Pediatric Therapeutics and Regulatory Science Initiative, Computational Health Informatics Program, Boston Children's Hospital, Boston, MA 02115, USA; Department of Pediatrics, Harvard Medical School, Boston, MA, USA. Electronic address: florence.bourgeois@childrens.harvard.edu.

Comment

Thomas J Hwang et al. Lancet Child Adolesc Health. 2023 Jul.

. 2023 Jul;7(7):e13.

doi: 10.1016/S2352-4642(23)00125-6.

¹ Pediatric Therapeutics and Regulatory Science Initiative, Computational Health Informatics Program, Boston Children's Hospital, Boston, MA 02115, USA; Cancer Innovation and Regulation Initiative, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Division of Urological Surgery, Brigham and Women's Hospital, Boston, MA, USA.
² Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
³ Pediatric Therapeutics and Regulatory Science Initiative, Computational Health Informatics Program, Boston Children's Hospital, Boston, MA 02115, USA; Department of Pediatrics, Harvard Medical School, Boston, MA, USA. Electronic address: florence.bourgeois@childrens.harvard.edu.

No abstract available

Conflict of interest statement

We declare no competing interests.

Impact of the EU Paediatric Medicine Regulation on new anti-cancer medicines for the treatment of children and adolescents.
Vassal G, de Rojas T, Pearson ADJ. Vassal G, et al. Lancet Child Adolesc Health. 2023 Mar;7(3):214-222. doi: 10.1016/S2352-4642(22)00344-3. Epub 2023 Jan 19. Lancet Child Adolesc Health. 2023. PMID: 36682367 Review.