Table of Contents
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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