Document Detail


Organization and ethical aspects of randomized trials in gynecologic oncology.
MedLine Citation:
PMID:  11144687     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Randomized trials remain often the most reliable method for evaluating the efficacy of therapies in Gynaecological Oncology. However, a trial can only be ethical acceptable if well conceived and well executed. One of the most important ethical issues in randomized trials is the informed consent. Patients must always be aware that they are part of an experiment and give voluntary informed consent. Only in very rare occasions an informed consent might be omitted (e.g. after agreement of a National Ethical Committee). Each randomized trial must have a good chance of settling an open question. The measures of outcome, should be carefully stated in the protocol. Each new protocol should be reviewed on at least 4 levels: by competent colleagues, an Ethical Review Board, a panel of scientists and the well-informed patient. Every randomized trial should be published in a peer reviewed medical journal, also when the results are negative or when the trial is stopped during accrual. Interim analyses of randomized trials result often in incorrect conclusions. These interim analyses should always be carefully planned and interpreted by an independent data-monitoring committee. International cooperative groups, such as the EORTC, often are the only organizations to perform large phase-III randomized trials. The creation of a Gynaecological Cancer Intergroup (GCIG) will increase the cooperation between the different international groups.
Authors:
I Vergote
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Verhandelingen - Koninklijke Academie voor Geneeskunde van België     Volume:  62     ISSN:  0302-6469     ISO Abbreviation:  Verh. K. Acad. Geneeskd. Belg.     Publication Date:  2000  
Date Detail:
Created Date:  2000-12-28     Completed Date:  2001-03-01     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0413210     Medline TA:  Verh K Acad Geneeskd Belg     Country:  Belgium    
Other Details:
Languages:  eng     Pagination:  385-95; discussion 395-8     Citation Subset:  IM    
Affiliation:
Dienst voor Verloskunde-Gynaecologie, Afdeling Gynaecologische Oncologie, Faculteit Geneeskunde, KULeuven, UZ-Gasthuisberg, Herestraat 49-B 3000 Leuven.
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MeSH Terms
Descriptor/Qualifier:
Ethics, Medical*
Female
Genital Neoplasms, Female* / therapy
Humans
Informed Consent
International Cooperation
Randomized Controlled Trials as Topic* / standards

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