Is a New Protocol for Acute Lymphoblastic Leukemia Research or Standard Therapy?
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.
Julius Center for Health Sciences and Primary Care, Department of Medical Humanities and.
Sara A S
SA
Dekking
Julius Center for Health Sciences and Primary Care, Department of Medical Humanities and.
Rieke
R
van der Graaf
Leiden University Medical Center, Department of Pediatrics, Leiden, Netherlands;
Martine C
MC
de Vries
Wilhelmina Children's Hospital, Department of Pediatric Hematology, University Medical Center Utrecht, Utrecht, Netherlands;
Marc B
MB
Bierings
Julius Center for Health Sciences and Primary Care, Department of Medical Humanities and.
Johannes J M
JJ
van Delden
Center for Ethics, Humanities and Spiritual Care, Lerner College of Medicine, Cleveland Clinic, Cleveland, Ohio; and.
Eric
E
Kodish
Children's Mercy Hospital, Kansas City, Missouri jlantos@cmh.edu.
John D
JD
Lantos
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001215:Asparaginase / Q000008:administration & dosage; D002648:Child; D002985:Clinical Protocols; D003520:Cyclophosphamide / Q000008:administration & dosage; D003561:Cytarabine / Q000008:administration & dosage; D003630:Daunorubicin / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage; D019317:Evidence-Based Medicine / Q000941:ethics; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D015122:Mercaptopurine / Q000008:administration & dosage; D008727:Methotrexate / Q000008:administration & dosage; D009426:Netherlands; D011092:Polyethylene Glycols / Q000008:administration & dosage; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy*; D011241:Prednisone / Q000008:administration & dosage; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation / Q000941:ethics*; D014481:United States; D014750:Vincristine / Q000008:administration & dosage
D003561:Cytarabine; D011092:Polyethylene Glycols; D014750:Vincristine; C042705:pegaspargase; D003907:Dexamethasone; D003520:Cyclophosphamide; D015122:Mercaptopurine; D001215:Asparaginase; D002955:Leucovorin; D011241:Prednisone; D008727:Methotrexate; D003630:Daunorubicin