Proceedings of the fourth Seattle symposium in biostatistics: clinical trials:
Gespeichert in:
| Körperschaft: | |
|---|---|
| Weitere Verfasser: | |
| Format: | Tagungsbericht Buch |
| Sprache: | English |
| Veröffentlicht: |
New York ; Heidelberg [u.a.]
Springer
2013
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| Schriftenreihe: | Lecture notes in statistics
1205 : Proceedings |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | VIII, 249 S. Ill. 24 cm |
| ISBN: | 9781461452447 |
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Datensatz im Suchindex
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| adam_text | Titel: Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials
Autor: Seattle Symposium in Biostatistics: Clinical Trials, 2010, Seattle, Wash
Jahr: 2013
Contents
Preface............................................................................. v
Part I Biomarkers: Role in the Design and Interpretation
of Clinical Trials
The Role and Potential of Surrogate Outcomes in Clinical
Trials: Have We Made Any Progress in the Past Decade?................... 3
David L. DeMets
On the Use of Biomarkers to Elucidate Clinical Trial Results:
Examples from the Women s Health Initiative............................... 21
Ross L. Prentice and Shanshan Zhao
On the Use of Biomarkers in Vaccine Research and Development......... 35
Steven G. Self
Part II Biomarkers: Issues in Individualized Therapy
Recent Developments in the Use of Clinical Trials to Support
Individualizing Therapies: A Regulatory Perspective....................... 49
Robert T. O Neill
Oncology Clinical Trials in the Genomic Era................................. 63
Richard Simon and Jyothi Subramanian
Using SNPs to Characterize Genetic Effects in Clinical Trials.............. 81
B.S. Weir
Part III Issues in Multi-Regional Clinical Trials
Why Is This Subgroup Different from All Other Subgroups?
Thoughts on Regional Differences in Randomized Clinical Trials......... 95
Janet Wittes
vii
viii
Contents
Part IV Safety
Quantitative Risk/Benefit Assessment: Where Are We?..................... 119
Christy Chuang-Stein
Identifying and Addressing Safety Signals in Clinical Trials:
Some Issues and Challenges.................................................... 137
Thomas R. Fleming
Past, Present, and Future of Drug Safety Assessment....................... 157
Robert Temple
Part V Special Topics
Designing, Monitoring, and Analyzing Group Sequential
Clinical Trials Using the RCTdesign Package for R........................ 177
Daniel L. Gillen and Scott S. Emerson
Genetic Markers in Clinical Trials............................................. 209
B.S. Weir and P.J. Heagerty
Addresses for Contact Authors (in the same order as the papers).......... 247
|
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| author_facet | Fleming, Thomas R. Seattle Symposium in Biostatistics: Clinical Trials Seattle, Wash |
| author_sort | Seattle Symposium in Biostatistics: Clinical Trials Seattle, Wash |
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| classification_rvk | SI 856 |
| ctrlnum | (OCoLC)826626884 (DE-599)BSZ377459429 |
| discipline | Mathematik |
| format | Conference Proceeding Book |
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| spelling | Seattle Symposium in Biostatistics: Clinical Trials 2010 Seattle, Wash. Verfasser (DE-588)1029591067 aut Proceedings of the fourth Seattle symposium in biostatistics: clinical trials Thomas R. Fleming ... eds. New York ; Heidelberg [u.a.] Springer 2013 VIII, 249 S. Ill. 24 cm txt rdacontent n rdamedia nc rdacarrier Lecture notes in statistics 1205 : Proceedings Clinical trials / Statistical methods / Congresses Biometry / Congresses (DE-588)1071861417 Konferenzschrift gnd-content Fleming, Thomas R. (DE-588)103147966X edt Lecture notes in statistics 1205 : Proceedings (DE-604)BV002447846 1205 : Proceedings HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=025685697&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Proceedings of the fourth Seattle symposium in biostatistics: clinical trials Lecture notes in statistics |
| subject_GND | (DE-588)1071861417 |
| title | Proceedings of the fourth Seattle symposium in biostatistics: clinical trials |
| title_auth | Proceedings of the fourth Seattle symposium in biostatistics: clinical trials |
| title_exact_search | Proceedings of the fourth Seattle symposium in biostatistics: clinical trials |
| title_full | Proceedings of the fourth Seattle symposium in biostatistics: clinical trials Thomas R. Fleming ... eds. |
| title_fullStr | Proceedings of the fourth Seattle symposium in biostatistics: clinical trials Thomas R. Fleming ... eds. |
| title_full_unstemmed | Proceedings of the fourth Seattle symposium in biostatistics: clinical trials Thomas R. Fleming ... eds. |
| title_short | Proceedings of the fourth Seattle symposium in biostatistics: clinical trials |
| title_sort | proceedings of the fourth seattle symposium in biostatistics clinical trials |
| topic_facet | Konferenzschrift |
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