Defining the Research Category in Pediatric Phase I Oncology Trials

TitleDefining the Research Category in Pediatric Phase I Oncology Trials
Publication TypeJournal Article
Year of Publication2015
AuthorsLad, PM, Dahl, R
JournalAccountability in Research: Policies & Quality Assurance
Date Published2015
Publication Languageeng
ISBN Number08989621
KeywordsClinical , Drug , Informed , IRB , Medical , Monitoring , ONCOLOGY , Pediatrics , quality
AbstractClinical research studies in children are classified by risk into three major categories. These are as follows: a) minimal risk studies, b) more than minimal risk studies but with benefit, and c) studies with minor increase over minimal risk but with no benefit. Pediatric Phase I oncology trials, which are conducted in a highly vulnerable population of severely ill children with cancer, are designed to establish safety and to determine the maximum tolerated dose (MTD), as well as establish dose limiting toxicity (DLT). These types of studies can be associated with significant risk. The research design of such high- risk studies, which comprise short-term treatments with varying doses, is generally not associated with any clinical benefit. Classification of the research category in these pediatric studies poses a special problem for the Institutional Review Board (IRB) with major implications for the consenting process. The challenges associated with the classification of such studies are discussed in this article. 
NotesLad, Pramod M. 1; Dahl, Rebecca 1; Affiliations: 1: Human Subjects Protection Program, Children’s Hospital Los Angeles, Los Angeles, California, USA; Issue Info: 2015, Vol. 22 Issue 3, p139; Thesaurus Term: QUALITY assurance; Subject Term: PEDIATRICS -- Practice; Subject Term: MEDICAL research; Subject Term: CLINICAL trials; Subject Term: DRUG tolerance; Subject Term: ONCOLOGY; Author-Supplied Keyword: clinical research; Author-Supplied Keyword: informed consent; Author-Supplied Keyword: IRB; Author-Supplied Keyword: monitoring; Author-Supplied Keyword: pediatrics; Author-Supplied Keyword: quality assurance; Number of Pages: 9p; Document Type: Article