Document Detail

Ethical issues in cooperative cancer therapy trials from a statistical viewpoint. II. Specific issues.
MedLine Citation:
PMID:  4037245     Owner:  NLM     Status:  MEDLINE    
Quality collaborative clinical trials cannot be run without the complete commitment of every investigator. The clinician must provide quality data and must submit the data on time. The statistical office and protocol coordinator are responsible for maintaining confidentiality and for keeping a watchful eye on the overall conduct of the study. Safety monitoring of experimental drugs or drug combinations is a central responsibility, since individual investigators generally only see the statistical reports on the study, rather than the raw data. It is critical that interim statistical reports be interpreted correctly so as not to affect accrual adversely. A separate issue discussed in this article is the answering of negative questions. Can therapy be reduced and still obtain equal efficacy? Such studies are based on sound ethical considerations, but they are hazardous since they could lead to serious worsening in cure rates.
J J Shuster; J P Krischer; J M Boyett
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  The American journal of pediatric hematology/oncology     Volume:  7     ISSN:  0192-8562     ISO Abbreviation:  Am J Pediatr Hematol Oncol     Publication Date:  1985  
Date Detail:
Created Date:  1985-10-15     Completed Date:  1985-10-15     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7908071     Medline TA:  Am J Pediatr Hematol Oncol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  64-70     Citation Subset:  E; IM    
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MeSH Terms
Antineoplastic Agents / therapeutic use
Clinical Trials as Topic / methods*
Drug Evaluation
Ethics, Medical*
Information Dissemination
Neoplasms / drug therapy,  therapy*
Research Design
Research Subjects
Grant Support
U-10 CA 29139-03/CA/NCI NIH HHS
Reg. No./Substance:
0/Antineoplastic Agents

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