Is a New Protocol for Acute Lymphoblastic Leukemia Research or Standard Therapy?

Sara A S Dekking, Rieke van der Graaf, Martine C de Vries, Marc B Bierings, Johannes J M van Delden, Eric Kodish, John D Lantos

Journal: Pediatrics 2015;136(3):566-70

PMID: 26283776

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Abstract

In the United States, doctors generally develop new cancer chemotherapy for children by testing innovative chemotherapy protocols against existing protocols in prospective randomized trials. In the Netherlands, children with leukemia are treated by protocols that are agreed upon by the Dutch Childhood Oncology Group. Periodically, the Dutch Childhood Oncology Group revises its protocols. Sometimes, these revisions are categorized as research, sometimes as treatment. In this Ethics Rounds, we analyze whether enrollment in a new protocol ought to be considered research and, if so, we discuss the implications of that designation. Our discussion highlights the different ways different countries approach complex issues of research ethics.

Address: Julius Center for Health Sciences and Primary Care, Department of Medical Humanities and.; Leiden University Medical Center, Department of Pediatrics, Leiden, Netherlands;; Wilhelmina Children's Hospital, Department of Pediatric Hematology, University Medical Center Utrecht, Utrecht, Netherlands;; Center for Ethics, Humanities and Spiritual Care, Lerner College of Medicine, Cleveland Clinic, Cleveland, Ohio; and.; Children's Mercy Hospital, Kansas City, Missouri [email protected].

DOI: 10.1542/peds.2014-2327

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MeSH Terms: Antineoplastic Combined Chemotherapy Protocols, Asparaginase, Child, Clinical Protocols, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone, Evidence-Based Medicine, Humans, Leucovorin, Mercaptopurine, Methotrexate, Netherlands, Polyethylene Glycols, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Prednisone, Risk Assessment, Therapeutic Human Experimentation, United States, Vincristine