Document Detail

Analysis and presentation. Clinical trials on prostate cancer.
MedLine Citation:
PMID:  9111615     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To present guidelines for the analysis and presentation of clinical trials on prostate cancer. METHODS: Textbooks in statistics and oncology were searched for information, as were separate articles on the topic. Previously published advice was fused with own experience. RESULTS: Minimum key points are given for the sections: Introduction, Materials and Methods, Results, Discussion, and Summary. The importance of 1 primary question in any clinical trial is stressed. The value of a detailed presentation of the trial design, the patient population and the inclusion/exclusion criteria, the characterization of the disease, the treatment schedules, and toxicity is underlined. Application of various statistical methods for different endpoints is suggested. Maturity of data, time for publication, and avoidance of publication bias are discussed. Some common pitfalls in the statistical analyses of clinical results are indicated. The impact of prognostic factors, proper staging procedures, and secondary treatments on the interpretation of survival analysis is pointed out. A shift from the (mis-)use of the P value in favor of confidence intervals is strongly encouraged. The use of comparing the survival of responders versus nonresponders is to be abandoned. A few practical hints concerning the presentation are offered. The minimum of data that should be presented in absolute numbers is indicated. Also, the data that should be provided in both graphic and numeric format are exemplified. Examples of essential graphic illustrations are provided. The need for improvements in the design analysis, and presentation of clinical trials is reemphasized. Finally, numerous references are listed. The article is addressed not only to authors and readers of clinical trials, but also to editors of medical journals. CONCLUSION: The suggested guidelines may be useful in the analysis, presentation, and interpretation of clinical trials on prostate cancer. Moreover, compliance with these guidelines may facilitate comparisons with other similar trials and also, the incorporation of single studies into metaanalyses.
S Friberg; A Taube; R Sylvester; J E Oesterling
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Urology     Volume:  49     ISSN:  0090-4295     ISO Abbreviation:  Urology     Publication Date:  1997 Apr 
Date Detail:
Created Date:  1997-05-12     Completed Date:  1997-05-12     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0366151     Medline TA:  Urology     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  54-65     Citation Subset:  IM    
Department of General Oncology, Karolinska Hospital, Stockholm, Sweden.
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MeSH Terms
Clinical Trials as Topic / methods*
Data Interpretation, Statistical
Patient Selection
Prostatic Neoplasms / therapy*
Quality Control

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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