100币求一本书《Clinical Trial Design: Bayesian and Frequentist Adaptive Methods

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【作者(必填)】Guosheng Yin

【文题(必填)】
Clinical Trial Design: Bayesian and Frequentist Adaptive Methods (Wiley Series in Probability and Statistics)
【年份(必填)】
2012
【全文链接或数据库名称(选填)】
http://www.amazon.com/Clinical-Trial-Design-Frequentist-Probability/dp/0470581719

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关键词：Frequentist Bayesian Adaptive FREQUENT Clinical 数据库 Design

这个领域没涉及，只好顶起。

你要的这本书下载不了，但下面的一本2011年新书可能您需要
Public Engagement and Clinical Trials: New Models and Disruptive Technologies

by Victoria Weisfeld, Rebecca A. English, Anne B. Claiborne
Workshop Summary. Forum on Drug Discovery, Development, and Translation; Institute of Medicine
NAS Press | 2011 | ISBN: 0309219299 9780309219297 | 117 pages | PDF | 6 MB
The IOM held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.

Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results.

Contents
ACRONYMS
1 INTRODUCTION
2 FRAMING THE PROBLEM
The Current Landscape of Clinical Trials
Panel Presentations and Discussion
3 RECRUITMENT CHALLENGES IN CLINICAL TRIALS FOR DIFFERENT DISEASES AND CONDITIONS
Cardiovascular Surgery
Working with Underserved Communities
Mental Health
4 MODELS FOR PUBLIC ENGAGEMENT
5 MESSAGES AND METHODS FOR PUBLIC ENGAGEMENT
Messages
Messengers
6 THE MEDIA
Balanced Coverage
Relationships with Researchers
Relationships with the Audience
Conflict of Interest
7 NOVEL CLINICAL TRIAL DESIGNS
Adaptive Clinical Trial Designs
Using Point-of-Care Clinical Trials to Create a Learning Health Care System
The Food and Drug Administration Perspective
8 THE HEALTH SYSTEM’S STRUCTURE AND CULTURE
Building a Supportive Clinical Trials Environment in Academi
Public-Private Partnerships in Cancer Trials
Engaging Community Physicians in Rheumatoid Arthritis Research
9 TOWARD A PATIENT-CENTERED STRATEGY FOR CLINICAL TRIALS
The Changing Politics of Clinical Trial Engagement
Closing Panel
REFERENCES
APPENDIXES
A WORKSHOP AGENDA
B THE CLINICAL TRIALS PROCESS
C PARTICIPANT BIOGRAPHIES

andy520 发表于 2012-2-21 17:33
你要的这本书下载不了，但下面的一本2011年新书可能您需要
Public Engagement and Clinical Trials: New M ...

还有一本好书，上传了。。。。
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Governing
Board of the National Research Council, whose members are drawn from the councils of
the National Academy of Sciences, the National Academy of Engineering, and the Institute
of Medicine. The members of the committee responsible for planning the workshop
were chosen for their special competences and with regard for appropriate balance.
This project was sponsored by the American Society of Clinical Oncology. The National
Cancer Policy Forum is supported by Contract Nos. HHSN261200900003C and 200-
2005-13434 TO #1 between the National Academy of Sciences and the National Cancer
Institute and the Centers for Disease Control and Prevention, respectively. This project
was also supported by the American Association for Cancer Research, the American
Cancer Society, the Association of American Cancer Institutes, Bristol-Myers Squibb,
C-Change, the CEO Roundtable on Cancer, Novartis Oncology, and the Oncology
Nursing Society. Any opinions, findings, conclusions, or recommendations expressed
in this publication are those of the author(s) and do not necessarily reflect the view of
the organizations or agencies that provided support for this project.
International Standard Book Number-13: 978-0-309-21268-7
International Standard Book Number-10: 0-309-21268-5
Additional copies of this report are available from the National Academies Press, 500
Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202)
334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.
For more information about the Institute of Medicine, visit the IOM home page at:
www.iom.edu.
Copyright 2011 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
The serpent has been a symbol of long life, healing, and knowledge among almost all
cultures and religions since the beginning of recorded history. The serpent adopted as a
logotype by the Institute of Medicine is a relief carving from ancient Greece, now held
by the Staatliche Museen in Berlin.
Suggested citation: IOM (Institute of Medicine). 2011. Implementing a National Cancer
Clinical Trials System for the 21st Century: Workshop Summary. Washington, DC: The
National Academies Press.

andy520 发表于 2012-2-21 18:40
还有一本好书，上传了。。。。
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC  ...

谢谢你的努力，但是我真的不需要这两本书，不好意思。我现在就需要我列的那本书

由于没有解决，所以我撤销帖子

我有一本书，叫<Clinical Trial methodology>

July 20, 2010 by Chapman and Hall/CRC - 420 Pages

Karl E. Peace, Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, USA;

Ding-Geng (Din) Chen, University of Rochester Medical Center, Rochester, New York, USA

Table of Contents
Overview of Clinical Trial Methodology
Clinical Trials
Clinical Trial Methodology
Summary of Clinical Trial Methodology

Overview of the Drug Development Process and Regulation of Clinical Trials
Introduction
The Drug Development Process
History of Drug Regulation
Principles of Adequate and Controlled Investigations
Content and Format of the IND
Content and Format of the NDA
Organizational Structure of the FDA
The FDA Review Process
Labeling and the Package Insert
Pharmaceutical Company Organization and Role of the Biostatistician

Ethical Considerations in the Design and Conduct of Clinical Trials
Introduction
History and Evolution of Ethical Considerations in Clinical Trials: Key Milestones
Independent Review Boards
Clinical Trial Ethics: Who Should Practice?
Informed Consent, Sample Size, and Power
Common Ethical Principles of Various Codes and Regulations

Sample Size Considerations in Clinical Trials Pre-Market Approval
Introduction
Phases of Clinical Trials and Objectives
The Clinical Development Plan: Pre-Market Approval
Sample Size Requirements
Examples
Philosophical Issues

Sequential, Group Sequential, Stochastic Curtailment, and Adaptive Design Procedures in Clinical Trials
Introduction
Sequential Procedures
Group Sequential Procedures
Stochastic Curtailment
Adaptively Designed Clinical Trials

Biostatistical Aspects of the Protocol
The Background or Rationale
Objective
Plan of Study
Statistical Analysis Section
Administration
Protocol References Section

The Statistical Analysis Plan
Introduction
Protocol Objective
Efficacy Data Collected and Protocol Schema
Primary and Secondary Efficacy Endpoints
Objectives, Translated as Statistical Hypotheses
Protocol Design Features
Statistical Analyses

Pooling of Data from Multicenter Clinical Trials
Introduction
Multicenter Clinical Trial Experimental Setting
Pre-Study Planning
Multicenter Clinical Trial Conduct
Biostatistical Analysis

Validity of Statistical Inference
Introduction
Planning the Investigation
Conducting the Investigation
Statistical Analyses, Interpretation, and Inference
Reporting Results of Investigations

Bioequivalence Clinical Trials
Introduction
Absorption, Distribution, Metabolism, and Excretion (ADME)
Bioavailability
Factors That Affect Bioavailability
Blood Level Clinical Trials
Bioequivalence
Design of Bioequivalence Trials
Analysis of Bioequivalence Trials
Analysis of Ratios
Pharmacokinetic Models
Support of Bioequivalence Trials in the Pharmaceutical Industry
Examples

Dose and Frequency Determination from Phase II Clinical Trials in Stress Test-Induced Angina
Introduction
Overview of Response Surface Methodology
Full Quadratic Response Surface Model
Phase II Clinical Trial Program in Stress Test-Induced Angina

Confirmation of Clinically Optimal Dosing in the Treatment of Duodenal Ulcers: A Phase III Dose Comparison Trial
Introduction
Background
Objective
Designing and Planning the Investigation
Conducting the Investigation
Statistical Analyses
Other Considerations
Innovative Aspects of the Clinical Trial Program

Pivotal Proof-of-Efficacy Clinical Trials in the Prevention of NANSAID-Induced Gastric Ulceration
Introduction
Rationale
The Protocols
Monitoring and Data Management
FDA Meeting

Clinical Trials in the Treatment of Alzheimer’s Disease Based upon Enrichment Designs
Introduction
Enrichment Design Clinical Trials
Objective
Primary Efficacy Endpoints
Sample Size Determination
Statistical Methods
Results

A Clinical Trial to Establish Reduction of CHD Risk
Introduction
Objective
Designing and Planning the Investigation
Conducting the Investigation
Data Management
Statistical Analyses
Results
Summary

Pivotal Proof-of-Efficacy Clinical Trials in the Treatment of Panic Disorder
Introduction
Design of Pivotal Proof-of-Efficacy Trials
Traditional Statistical Analysis Methods
Overview of Efficacy Results of the Two Trials
Alternative Design and Analysis Strategies

Combination Clinical Trials
Introduction
Two-by-Two Factorial Design
Effectiveness of the Combination
Contribution of Components to the Effectiveness of the Combination
Factorial Designs in Other Clinical Development Areas
Example 1: Actifed in the Treatment of SAR Following DESI Review
Example 2: Crossover Trial of Actifed in the Treatment of SAR
Example 3: Parallel Trial of Actifed in the Treatment of the Common Cold

Monitoring Clinical Trials for Adverse Events
Introduction
Designing for Safety: Antibiotic Rash Example
Designing for Safety: Hypokalemia Example
Designing for Safety: Hypertensive Rebound Example
Premarket Approval Trials: Designed for Efficacy
Premarket Approval Trials: Quality of Adverse Event Information
Monitoring for Safety
Statistical Methodology: Individual Trial
Example
Statistical Methodology: Across Trials

Index

xzp0711 发表于 2012-3-26 10:40
我有一本书，叫

July 20, 2010 by Chapman and Hall/CRC - 420 Pages

你可以分享 or 出售给我吗？

很奇怪，我无法上传，请问除了在这里交易，还能怎么交易呢？