Who Should Go First in Trials with Scarce Agents?: The Views of Potential Participants

TitleWho Should Go First in Trials with Scarce Agents?: The Views of Potential Participants
Publication TypeJournal Article
Year of Publication2007
AuthorsPentz, RD, Flamm, AL, Sugarman, J, Cohen, MZ, Zhiheng, X, Herbst, RS, Abbruzzese, JL
JournalIRB: Ethics & Human Research
Volume29
Issue4
Pagination1-6
Type of ArticleArticle
Publication Languageeng
ISSN Number01937758
Accession Number26225989
Keywordsaids , Clinical , Drug , HEALTH , Medical , PUBLIC , United
AbstractThe article reports on issues and topics concerning the Food and Drug Administration (FDA)'s disapproval on the demands from AIDS activists in the nineteen eighties for access to drugs in the U.S. This decision has resulted in multiple programs to increase access including single patient treatment Investigational New Drug (IND) applications, treatment IND for groups of patients, and a streamlined approval process for promising agents.
NotesPentz, Rebecca D. 1 Flamm, Anne L. 2 Sugarman, Jeremy 3 Cohen, Marlene Z. 4,5,6,7 Zhiheng Xu 8 Herbst, Roy S. 9,10 Abbruzzese, James L. 11; Affiliation: 1: Professor, Hematology and Oncology in Research Ethics, Winship Cancer Institute, Emory University, Atlanta, GA 2: Visiting Assistant Professor, Case University School of Law, Cleveland, OH 3: Harvey M. Meyerhoff Professor, Bioethics and Medicine, Berman Institute of Bioethics and Department of Medicine, Johns Hopkins University, Baltimore 4: John S. Dunn, Sr., Distinguished Professor, Oncology Nursing, University of Texas Health Science Center Houston School of Nursing 5: Assistant Dean, University of Texas Health Science Center Houston School of Nursing 6: Chair, Department of Integrative Nursing Care, University of Texas Health Science Center Houston School of Nursing 7: Professor, Department of Symptom Research, University of Texas M.D. Anderson Cancer Center, Houston, TX 8: Biostatician, Department of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, GA 9: Chief, Section of Thoracic Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX 10: Codirector, Phase I Clinical Trials Working Group, University of Texas M.D. Anderson Cancer Center, Houston, TX 11: Chair, Department of GI Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX; Source Info: Jul/Aug2007, Vol. 29 Issue 4, p1; Subject Term: AIDS activists; Subject Term: HEALTH services accessibility; Subject Term: DRUG development; Subject Term: CLINICAL trials; Subject Term: MEDICAL laws & legislation; Subject Term: PUBLIC health administration; Subject Term: UNITED States; Company/Entity: UNITED States. Food & Drug Administration; NAICS/Industry Codes: 923120 Administration of Public Health Programs; Number of Pages: 6p; Document Type: Article
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