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November 2005 

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A New Paradigm for Clinical Development:
The Clinical Trial in 2015

Hermann A.M. Mucke, Ph.D.

New Page 1

Figure 1.1. New Active Substances (NASs) Launched Worldwide, 1995–2004

Figure 1.2. The Drug Development Process

Figure 1.3. Investment Escalation per Successful Compound

Figure 1.4. Attrition during the Clinical Development Process

Figure 2.1. Comparison of the Conventional and the Microdose Approach to Candidate Selection

Figure 2.2. The Radiofrequency Indentifier–Based Med-ic™ ECM™ Smart Package for Clinical Supplies and Output from Med-ic™ Certi-Scan™ Software

Figure 2.3. Data Flow and Processing in a Typical E-Clinical Trial

Figure 3.1. Projected Schematic Development of Medicine and Healthcare toward Personalized Medicine

Figure 3.2. Representation of Raw Data from a Clinical Trial that Allows Patients to be Clustered Based on Drug Response

Figure 3.3. Schematic Representation of the VOTES Clinical Trial Grid Computing Study

Figure 4.1. The FDA’s Concept of the Three Dimensions of the “Critical Path” in Drug Development

Table 2.1. F eatures of Typical Electronic Patient-Reported Outcome Information Technology Tools

 


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