Can Underpowered Clinical Trials Be Justified?

TitleCan Underpowered Clinical Trials Be Justified?
Publication TypeJournal Article
Year of Publication2004
AuthorsRosoff, PM
JournalIRB: Ethics & Human Research
Volume26
Issue3
Pagination16-19
Type of ArticleArticle
Publication Languageeng
ISSN Number01937758
Accession Number14683104
KeywordsClinical , DISEASES , Human , MEDICINE , Patients , THERAPEUTICS
AbstractThe article discusses several issues related to clinical trials. The goal of human clinical trials is to identify safe and effective therapies. To justify exposing individuals to the risks of new interventions physicians often balance the severity of the illness under study, the known and potential risks of the study and control therapies, and the possible benefit future patients with the same or similar illnesses might derive from the new intervention. Many investigators justify increased risks to subjects by conflating a combination of the availability of treatments and the chances of harm due to the disease itself. Indeed, they often rationalize the exposure to enormous risk if the medical condition is serious enough.
NotesRosoff, Philip M. 1; Affiliation: 1: Chief of division of Hematology-Oncology, Department of Pediatrics at Duke University Medical Center.; Source Info: May/Jun2004, Vol. 26 Issue 3, p16; Subject Term: CLINICAL trials; Subject Term: MEDICINE -- Research; Subject Term: PATIENTS; Subject Term: DISEASES; Subject Term: THERAPEUTICS; Subject Term: HUMAN experimentation in medicine; NAICS/Industry Codes: 541712 Reseach and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 4p; Document Type: Article
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