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The Critical Role of Academic Clinical Trials in Pediatric Cancer Drug Approvals: Design, Conduct, and Fit for Purpose Data for Positive Regulatory Decisions | Journal of Clinical Oncology
The development of effective treatments for children with cancer has long been a focus of academic pediatric oncologists and a matter of strong international academic collaboration. Disease-focused academic consortia have been very successful in conducting multiagent and multimodality clinical trials aiming to optimize frontline and salvage treatment regimens.
The Critical Role of Academic Clinical Trials in Pediatric Cancer Drug Approvals: Design, Conduct, and Fit for Purpose Data for Positive Regulatory Decisions | Journal of Clinical Oncology
Critical Role of Academic Clinical Trials in Pediatric Cancer Drug Approvals: Design, Conduct, and Fit for Purpose Data for Positive Regulatory Decisions The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript.
Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies
Highlights • ALK is an important oncogene and target in several paediatric tumours. • There are many ALK inhibitors but a small number of children with ALK malignancies. • Focused and sequential development of ALK inhibitors is required. • There are now more trials of ALK inhibitors and regulatory submissions than in 2017. Abstract The first (2017) and sixth (2021) multistakeholder Paediatric Strategy Forums focused on anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies.
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