000			05360nam a2200493Ii 4500
001			9781315154435
003			FlBoTFG
005			20220509193112.0
006			m o d
007			cr
008			190122s2018 fluab ob 001 0 eng d
020			_a9781315154435(e-book : PDF)
035			_a(OCoLC)1066115091
040			_aFlBoTFG _cFlBoTFG _erda
050		4	_aRC271 _b.C5
072		7	_aMAT _x029000 _2bisacsh
072		7	_aMED _x090000 _2bisacsh
072		7	_aMED _x071000 _2bisacsh
072		7	_aPBT _2bicscc
082	0	4	_a616.99/4061 _223
245	0	0	_aStatistical Approaches in Oncology Clinical Development : _bCurrent Paradigm and Methodological Advancement / _cedited by Satrajit Roychoudhury and Soumi Lahiri.
250			_aFirst edition.
264		1	_aBoca Raton, FL : _bChapman and Hall/CRC, _c2018.
300			_a1 online resource (236 pages) : _b79 illustrations, text file, PDF.
336			_atext _2rdacontent
337			_acomputer _2rdamedia
338			_aonline resource _2rdacarrier
490	1		_aChapman & Hall/CRC Biostatistics Series
504			_aIncludes bibliographical references and index.
505	0	0	_t1. Introduction -- [Ohad Amit] -- 2. Statistical Considerations in Phase I Oncology Trials -- [Simon Wandel and Satrajit Roychoudhury] -- 3. ExposureResponse Analysis in Oncology Trials -- [Yi-Lin Chiu and Balakrishna S. Hosmane] -- 4. Statistical Measures of Interaction for Evaluating a Predictive -- Biomarker -- [Jaya Satgopan] -- 5. Design Considerations for Phase II Oncology Clinical Trials -- [Jared C. Foster, Jennifer Le-Rademacher, and Sumithra J. Mandrekar] -- 6. Precision Medicine and Associated Challenges -- [Rajesh Talluri and Sanjay S. Shete] -- 7. Use of Adaptive Design in Late-Stage Oncology Trials -- [Satrajit Roychoudhury, Arunava Chakravartty, and Pabak Mukhopadhyay] -- 8. Safety Monitoring and Analysis in Oncology Trials -- [Anastasia Ivanova, Qi Jiang, Olga Marchenko, and Richard C. Zink] -- 9. Quality of Life -- [Diane Fairclough] -- 10. Impact of Evolving Regulatory Pathways on Statistical -- Considerations in Oncology Clinical Trials -- [Rajeshwari Sridhara].
520	3		_aStatistical Approaches in Oncology Clinical Development : Current Paradigm and Methodological Advancement presents an overview of statistical considerations in oncology clinical trials, both early and late phase of development. It illustrates how novel statistical methods can enrich the design and analysis of modern oncology trials. The authors include many relevant real life examples from the pharmaceutical industry and academia based on their first-hand experience. Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development. The early part of the book covers novel phase I dose escalation design, exposure response analysis, and innovative phase II design. This includes early development strategy for cancer immunotherapy trials. The contributors also emphasized the role of biomarker and modern era of precision medicine. The second part focuses on the late stage development. This includes the application of adaptive design, safety analysis, and quality of life (QoL) data analysis. The final part discusses current regulatory perspective and challenges. Features: Covers a wide spectrum of topics related to real-life statistical challenges in oncology clinical trials. Provides a comprehensive overview of novel statistical methods to improve trial design and statistical analysis. Detailed case studies illustrate the real life applications. Satrajit Roychoudhury is a Senior Director and a member of the Statistical Research and Innovation group in Pfizer Inc. Prior to joining; he was a member of Statistical Methodology and consulting group in Novartis. He has 11 years of extensive experience in working with different phases of clinical trial. His area of research includes early phase oncology trials, survival analysis, model informed drug development, and use of Bayesian methods in clinical trials. He is industry co-chair for the ASA Biopharmaceutical Section Regulatory-Industry Workshop and has provided statistical training in major conferences including the Joint Statistical Meetings, ASA Biopharmaceutical Section Regulatory-Industry Workshop, and ICSA Applied Statistics Symposium. Soumi Lahiri has 12 years of extensive experience in working different therapeutic areas. She is the former Director of Biostatistics in Clinical Oncology, GlaxoSmithKline. She has also worked in the oncology division of Novartis Pharmaceutical Company for two years. She is an active member of the ASA Biopharmaceutical section and former chair of the membership committee.
530			_aAlso available in print format.
650		7	_aMEDICAL / Biostatistics. _2bisacsh
650		7	_aMEDICAL / Pharmacology. _2bisacsh
650		0	_aAntineoplastic agents _xDevelopment.
650		0	_aCancer _xChemotherapy.
650		0	_aDrugs _xTesting.
655		0	_aElectronic books.
700	1		_aRoychoudhury, Satrajit, _eeditor.
700	1		_aLahiri, Soumi, _eeditor.
710	2		_aTaylor and Francis.
776	0	8	_iPrint version: _z9781498772693
830		0	_aChapman & Hall/CRC Biostatistics Series.
856	4	0	_uhttps://www.taylorfrancis.com/books/9781315154435 _zClick here to view
999			_c129884 _d129884