Phase I Clinical Trials

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Use this report to address the major factors behind uncertainty in the management of Phase 1 clinical trials. Navigate key cost-drivers, including number of patients, patient visits, trial duration and specialty trial requirements. Data show total trial costs, per-patient costs and per-patient visit costs across 10 key therapeutic areas, including oncology and central nervous system. Balance in-house and vendor capabilities to increase patient recruitment, and analyze staffing metrics, including sponsor headcounts, for 25 Phase 1 trials across therapeutic areas. Lastly, follow strategic recommendations for vendor selection and management

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Report Details

Publication Date: January 2013
Pages: 112
Chapters: 4
Metrics: 500+
Charts/Graphics: 70+

Top Reasons to Read this Phase One Clinical Trials Report 

Control critical cost drivers: Total trial costs increase with protocol complexity. Manage key cost-drivers, including number of patients, patient visits, trial duration and specialty trial requirements. Examine benchmarks detailing total trial costs, per-patient costs and per-patient visit costs across 10 key therapeutic areas, including oncology and central nervous system.

Boost phase one clinical trials planning to prevent delays — and propel teams toward trial completion Set defined milestones and explore phase one clinical trials duration data for each stage of the process, and draw on executives’ strategies for keeping ahead of schedule.

Right-size your clinical team and improve vendor management: Balance in-house and vendor capabilities to increase patient recruitment, and analyze staffing metrics, including sponsor headcounts, for 25 Phase one clinical trials across therapeutic areas. Lastly, follow strategic recommendations for vendor selection and management.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource as well as our individual clinical development research reports.

Excerpt from Cost Drivers of Phase I Trials

The pharmaceutical industry is feverishly searching for the next big drug to replace lost revenue from blockbuster medicines’ patent expirations. Drugs with more than $30 billion in annual revenue lost patent protection in the last two years. Patent expirations — and the accompanying lost revenue — place great strain on all areas of the company. Much of that burden falls to clinical development teams charged with ushering investigational medicines to market. Phase 1 is an important step for investigational compounds on the journey to regulatory approval. But Phase 1 trials are not as straightforward as
they once were.

The rapid expansion of clinical development into oncology and orphan diseases has altered the otherwise predictable Phase 1 protocol design process. The ability to test for safety and efficacy in actual patients can speed up a product’s overall clinical development, but it also radically alters Phase 1 timetables and cost models. Patient recruitment, typically not an impediment for Phase 1 trials with healthy subjects, becomes an immediate concern for drugs seeking fast-track approval. Trial managers must add investigator sites or amend the protocol if patient enrollment stalls.

Table of Contents

9              Executive Summary

12           Study Methodology

13           Study Definitions

14           Phase 1 Management: Key Recommendations

21           Early-Stae Clinical Structure and Trial Staffing

23           Phase 1 Management Group Structures

38           Advancing Products Into and Beyond Phase 1

43           Phase 1 Trial Budgets and Cost-Drivers

44           Phase 1 Trial Budgets

54           Phase 1 Trial Cost-Drivers

76           Comparing Planned Versus Actual Phase 1 Trial Duration

88           Average Phase 1 Trial Duration

99           Phase 1 Outsourcing and Vendor Management

101         Outsourcing Strategy

110         Vendor Relationship Management

Charts and Graphics

Executive Summary

14           Figure E.1: Average Cost Per Patient in Phase 1 Clinical Trials, by Number of Patient Visits in Protocol

Phase 1 Management: Key Recommendations

16           Figure E.2: Average Percentage of Time Dedicated to Specific Activities in Phase 1

17           Figure E.3: Advancing Products into Phase 1: Company A

19           Figure E.4: Average Months Until All Sites Active, by Number of Sites

Early-Stae Clinical Structure and Trial Staffing

Phase 1 Management Group Structures

24           Figure 1.1: Phase 1 Team Structure: Company F

25           Figure 1.2: Phase 1 Team Structure: Company B

27           Figure 1.3: In-House Clinical Development Team: Company G

28           Figure 1.4: Phase 1 Team Structure: Company A

31           Figure 1.5: Average Sponsor Headcount for All Phase 1 Trials

32           Figure 1.6: Sponsor Headcount for Oncology Phase 1 Trials

33           Figure 1.7: Sponsor Headcount for Cardiovascular Phase 1 Trials

34           Figure 1.8: Sponsor Headcount for Central Nervous System/Neurology Phase 1 Trials

35           Figure 1.9: Sponsor Headcount for Women’s Health Phase 1 Trials

36           Figure 1.10: Sponsor Headcount for Gastroenterology Phase 1 Trials

37           Figure 1.11: Sponsor Headcount for Therapeutics with One Reported Phase 1 Trial

Advancing Products Into and Beyond Phase 1

39           Figure 1.12: Advancing Products into Phase 1: Company E

40           Figure 1.13: Advancing Products into Phase 1: Company A

Phase 1 Trial Budgets and Cost-Drivers

Phase 1 Trial Budgets

47           Figure 2.1: Average Trial Costs for All Phase 1 Trials, by Therapeutic Area

48           Figure 2.2: Total Costs for Phase 1 Oncology Clinical Trials

49           Figure 2.3: Total Costs for Phase 1 Cardiology Clinical Trials

50           Figure 2.4: Total Costs for Phase 1 Central Nervous System Clinical Trials

51           Figure 2.5: Total Costs for Phase 1 Gastroenterology Clinical Trials

52           Figure 2.6: Total Costs for Phase 1 Women’s Health Clinical Trials

53           Figure 2.7: Total Costs for Phase 1 Across Various Therapeutic Areas

54           Figure 2.8: Average Patient Enrollment and Dropout Rate for All Phase 1 Trials

Phase 1 Trial Cost-Drivers

56           Figure 2.9: Average Patient Enrollment in Phase 1 Clinical Trials, by Therapeutic Area

57           Figure 2.10: Average Patients Completing Phase 1 Clinical Trials, by Therapeutic Area

58           Figure 2.11: Average Patient Dropout Rate in Phase 1 Clinical Trials, by Therapeutic Area

59           Figure 2.12: Average Per-Patient Costs in Phase 1 Clinical Trials, by Therapeutic Area

60           Figure 2.13: Average Per-Patient Costs in Phase 1 Oncology Clinical Trials

61           Figure 2.14: Average Per-Patient Costs in Phase 1 Cardiology Clinical Trials

61           Figure 2.15: Average Per-Patient Costs in Phase 1 Central Nervous System Clinical Trials

62           Figure 2.16: Average Per-Patient Costs in Phase 1 Gastroenterology Clinical Trials

63           Figure 2.17: Average Number of Patient Visits in Phase 1 Protocol, by Therapeutic Area

64           Figure 2.18: Average Cost Per Patient in Phase 1 Clinical Trials, by Number of Patient Visits in Protocol

65           Figure 2.19: Average Cost Per Patient Per Visit in Phase 1 Clinical Trials, by Therapeutic Area

66           Figure 2.20: Average Cost Per Patient Per Visit in Phase 1 Oncology Clinical Trials

67           Figure 2.21: Average Cost Per Patient Per Visit in Phase 1 Cardiology Clinical Trials

67           Figure 2.22: Average Cost Per Patient Per Visit in Phase 1 Central Nervous System Clinical Trials

68           Figure 2.23: Average Cost Per Patient Per Visit in Phase 1 Gastroenterology Clinical Trials

69           Figure 2.24: Average Phase 1 Cost Per Patient, by Trial Duration

70           Figure 2.25: Average Cost Per Patient Per Month in Phase 1 Clinical Trials, by Therapeutic Area

71           Figure 2.26: Average Cost Per Patient Per Month in Phase 1 Oncology Clinical Trials

72           Figure 2.27: Average Cost Per Patient Per Month in Phase 1 Cardiology Clinical Trials

72           Figure 2.28: Average Cost Per Patient Per Month in Phase 1 Central Nervous System Clinical Trials

73           Figure 2.29: Average Cost Per Patient Per Month in Phase 1 Gastroenterology Clinical Trials

Comparing Planned Versus Actual Phase 1 Trial Duration

77           Figure 3.1: Planned Versus Actual Phase 1 Trial Milestones

79           Figure 3.2: Planned Duration of Phase 1 Cardiology Clinical Trials

79           Figure 3.3: Actual Duration of Phase 1 Cardiology Clinical Trials

80           Figure 3.4: Planned Duration of Phase 1 Central Nervous System Clinical Trials

81           Figure 3.5: Actual Duration of Phase 1 Central Nervous System Clinical Trials

82           Figure 3.6: Planned Duration of Phase 1 Gastroenterology Clinical Trials

83           Figure 3.7: Actual Duration of Phase 1 Gastroenterology Clinical Trials

84           Figure 3.8: Planned Duration of Phase 1 in Women’s Health Clinical Trials

85           Figure 3.9: Actual Duration of Phase 1 in Women’s Health Clinical Trials

87           Figure 3.10: Planned Phase 1 Duration in Oncology Clinical Trials

87           Figure 3.11: Actual Duration of Phase 1 Oncology Clinical Trials

Average Phase 1 Trial Duration

89           Figure 3.12: Average Percentage of Time Dedicated to Specific Phase 1 Activities

89           Figure 3.13: Average Percentage of Time Spent Per Clinical Operations Stage for All Phase 1 Trials

91           Figure 3.14: Average Percentage of Time Dedicated to Specific Activities in Phase 1 Cardiology Trials

91           Figure 3.15: Average Percentage of Time Spent Per Clinical Operations Stage for Phase 1 Cardiology Trials

92           Figure 3.16: Average Percentage of Time Dedicated to Specific Activities in Phase 1 Central Nervous System Trials

93           Figure 3.17: Average Percentage of Time Spent Per Clinical Operations Stage for Phase 1 Central Nervous System Trials

94           Figure 3.18: Average Percentage of Time Dedicated to Specific Activities in Phase 1 Diabetes (Type 2) Trials

95           Figure 3.19: Average Percentage of Time Spent Per Clinical Operations Stage for Phase 1 Diabetes (Type 2) Trials

96           Figure 3.20: Average Percentage of Time Dedicated to Specific Activities in Phase 1 Oncology Trials

97           Figure 3.21: Average Percentage of Time Spent Per Clinical Operations for Phase 1 Oncology Trials

Phase 1 Outsourcing and Vendor Management

100         Figure 4.1: Average Percentage of Phase 1 Trial Costs Outsourced

101        Figure 4.2: Average Percentage of Phase 1 Trial Costs Outsourced, by Therapeutic Area

Outsourcing Strategy

105         Figure 4.3: Percentage of Trials by Number of Sites

105         Figure 4.4: Average Number of Sites Per Trial, by Therapeutic Area

106         Figure 4.5: Percentage of Sites Unable to Recruit Patients for Trials with Multiple Sites

107         Figure 4.6: Percentage of Site Drop-Off by Number of Sites

108         Figure 4.7: Average Number of Months Until All Sites Are Active, by Number of Sites

109         Figure 4.8: Average Number of Months Until All Sites Are Active, by Therapeutic Area