| Ethical issues in cooperative cancer therapy trials from a statistical viewpoint. II. Specific issues. | |
| | |
MedLine Citation:
|
PMID: 4037245 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
J J Shuster; J P Krischer; J M Boyett |
Related Documents
:
|
15860765 - Increasing the degrees of freedom in existing group randomized trials: the df* approach. 2697015 - Ensuring data quality in a multicenter clinical trial: remote site data entry, central ... 3060315 - Statistical properties of randomization in clinical trials. 17591655 - Pharmacological models in healthy volunteers: their use in the clinical development of ... 18499695 - Em-random forest and new measures of variable importance for multi-locus quantitative t... 9832965 - Time-dependent sensitization--possible implications for clinical psychopharmacology. |
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 |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Antineoplastic Agents
/
therapeutic use Biometry Clinical Trials as Topic / methods* Confidentiality Drug Evaluation Ethics, Medical* Humans Information Dissemination Neoplasms / drug therapy, therapy* Probability Research Design Research Subjects |
| Grant Support | |
ID/Acronym/Agency:
|
U-10 CA 29139-03/CA/NCI NIH HHS |
| Chemical | |
Reg. No./Substance:
|
0/Antineoplastic Agents |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Ethical issues in cooperative cancer therapy trials from a statistical viewpoint. I. A general overv...
Next Document: Transient granulocyte maturation arrest: discovery by flow cytometry of a variant form of agranulocy...