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Reportlinker Adds The Clinical Trials Business
Date:12/14/2010

e conducted with leaders from trade associations, universities, the Food and Drug Administration (FDA), and professional agencies. Further information was obtained through an extensive literature search and conference attendance. Forecasts were based on 10K filings, specific factors that could impact clinical trials, and conversations with industry insiders.

Chapter- 1: INTRODUCTION -- Complimentary

STUDY GOALS AND OBJECTIVES 1

REASONS FOR DOING THE STUDY 1

INTENDED AUDIENCE 2

METHODOLOGY 2

ANALYST CREDENTIALS 2

SCOPE OF REPORT 2

INFORMATION SOURCES 3

RELATED BCC REPORTS 3

BCC ONLINE SERVICES 3

DISCLAIMER 4

Chapter-2: SUMMARY

SUMMARY 5

SUMMARY TABLE
U.S. FORECAST OF SPONSORED CLINICAL TRIALS MARKET, THROUGH 2014 6

SUMMARY FIGURE
U.S. FORECAST OF SPONSORED CLINICAL TRIALS MARKET, 2009-2014 ($ BILLIONS) 7

Chapter-3: OVERVIEW

TYPES OF CLINICAL TRIALS 8

CLINICAL TRIAL PHASES 8

WHO SPONSORS CLINICAL TRIALS? 8

TABLE 1 U.S. FORECAST OF SPONSORED CLINICAL TRIALS, THROUGH 2014 9

FIGURE 1 U.S. SPONSORED CLINICAL TRIALS MARKET, 2009-2014 ($ BILLIONS) 9

FIGURE 2 DRUG DEVELOPMENT TIME LINE 10

TABLE 2 PHASES OF THE CLINICAL TRIAL 10

PHASE I 11

PHASE II 11

PHASE III 12

PHASE IV/POST-MARKETING TRIALS 12

FACTORS AFFECTING STUDY SIZE 12

PHYSICIAN AND PATIENT RECRUITMENT 13

U.S. GOVERNMENT REGULATIONS 14

PHARMACEUTICALS AND BIOLOGICS 14

TABLE 3 U.S. LAWS AFFECTING DRUG APPROVAL TIMES 14

Additional U.S. Laws Affecting Clinical Trials 14

Health Insurance Portability and Accountability Act of 1996 (HIPAA) 14

Best Pharmaceuticals for Children Act (BPCA), 2002 15

TABLE 4 TOTAL APPROVED ACTIVE MOIETIES WITH NO MARKETING PROTECTION FOR WHICH FDA HAS ISSUED A WRITTEN REQUEST 16

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