Chapter
1. Clinical Trials Today
1.1. More Targets, More Research and Development Spending, More Candidate
Drugs—and Fewer New Products
1.2. The Clinical Trial Process: From Phase I to Phase IV
1.3. A Strategic Problem Analysis
Why Do Phase III Trials Fail So Frequently?
High-Profile Market Recalls: The Worst-Case Scenario Enacted
Approved but Not Effective in All Eligible Patients
Chapter 2. Current Strategies for Clinical Streamlining
2.1. Cost-Effective Solutions for Clinical Go/No-Go Decisions
Better Disease Models that Are Predictive of Human Exposure
Human Microdosing: "Phase Zero"
2.2. Optimized Project Planning
2.3. Recruiting the "Right" Patients More Quickly—and Keeping
Them
Maximizing Outpatient Compliance
"Offshoring" Clinical Trials
2.4. "Information-Rich" Trial Design and Biomarkers
Pharmacogenomics
Biomarkers for Clinical Monitoring
2.5. Electronic Data Capture: Heading for the "E-Trial"
Digitizing the Case Report Form
Interactive Voice Response Systems and Web-Supported Trials
The E-Trial: A "Revolutionary Evolution"
2.6. Mining Clinical Databases
Chapter 3. Forces Shaping Future Clinical Trials
3.1. The Confounding Mega-Trends
3.2. Paradigm Changes Rather than Technological Leaps at the Clinical
Inflection Point
3.3. Systems Biology as a Key to Understanding Disease and Patients’ Reactions
to Drugs
The Virtual Patient: A "Crash Dummy" for the Pharmaceutical Industry
3.4. Beyond Today's Biomarkers
Molecular Fingerprinting and Metabolomics
Functional Endpoints Defined by Molecular Imaging
Theranostics: The Co-Evolvement of Drugs and Diagnostics
3.5. Pervasive Computing: Can a New Type of Information Technology Bring Trials
to New Shores?
Clinical Data Management Systems (CDMS)
The Omnipresent Radiofrequency Tags
Grid Computing, Virtual Trial Organizations, and Data Interchange
Chapter 4. Regulatory Agencies in an
Era of Change
4.1. The FDA Takes the Initiative
The FDA's "Exploratory Investigational New Drug Application" Guideline
The FDA's Critical Path Document
The Biomarker Bootstrap Situation
The FDA and the Emerging E-Trial Modalities
4.2. The Thorough QT Trial: An Example for International Coordination of Clinical
Study Reform
4.3. The Dwindling Role of the Placebo
4.4. Focused Postmarketing Surveillance Instead of Megatrials
Chapter 5. A Scenario for Clinical Trials in the Year 2015
Chapter 6. Corporate Profiles
Clinphone Group
Compugen
Entelos, Inc.
eTrials Worldwide, Inc.
Gene Network Sciences
IBM Healthcare and Life Sciences
Lifetree Technology LLC
References
Index
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