Adaptive Design Clinical Trials

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This report provides benchmarks for adaptive trial design, including qualitative and quantitative metrics that examine companies’ use of adaptive trial designs, how these designs may affect clinical team responsibilities, and how to create strategies associated with adaptive design clinical trials.

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Report Details 

This report explores adaptive design clinical trials. An adaptive trial allows teams to prospectively plan adjustments to clinical trial parameters (such as patient sample size and dosing arms) ahead of clinical trial start-up. Teams can implement these plans as studies progress.

  • Number of graphics: 91
  • Data splits:
  • Company size:
    • Top 10
    • Top 50
    • Small
    • Biotech
    • Device/Diagnostic
  • Therapeutic area:
    • Autoimmune
    • Diabetes (Type 2)
    • Cardiovascular
    • Cardio and Thrombosis
    • CNS
    • Hematology
    • Immunology
    • Infectious Diseases
    • Inflammation
    • Nephrology
    • Neurology
    • Non-Surgical Devices
    • Oncology
    • Rheumatology
    • Surgical Devices

Data highlights include:

  • Sponsor organization executives’ perspectives on potential benefits and challenges of adaptive trial design.
  • Benchmarks showing current (2015) ratios of adaptive to non-adaptive studies across 11 therapeutic areas (for surveyed companies).
  • Metrics tracking level of involvement in adaptive trial design from 11 functions companywide, as well as CROs/vendors.
  • Cost-per-patient benchmarks for early- and late-stage adaptive and non-adaptive trials across 9 selected adaptive design types.
  • Ratings of specific adaptive trial design planning and execution challenges
  • 12 profiles showing how real teams across the life sciences (pharma, biotech, device and diagnostic) are using adaptive design.
    • Where available, profiles contain information regarding:
      • Company type and team scope of responsibility
      • Target therapeutic area
      • Number of total trials in target therapeutic area versus number of trials with adaptive design elements
      • Specific adaption(s) used, by development stage
      • Estimated time saved by using specific adaptive trial types, by development stage (in months)
      • Per-patient cost of specific adaptive trial types, by development stage (in USD)
      • Number of key staffing roles necessary to support specific adaptive trial types, by trial development stage
    • Three key recommendations and findings based on these profiles’ data.

Top Reasons to Buy this Adaptive Design Clinical Trials Report

Increase your odds of success in Phase 3 trials by implementing a well-researched adaptive design plan during early research stages: Employing adaptive design clinical trials may require companies to develop specialized groups or to conduct outside research to help familiarize teams with this study methodology. Proper trial planning and execution does not necessarily require additional resources, but rather prioritizing adaptive plans over other needs.  This study includes detailed best practices, insights and strategies for expanding adaptive design clinical trials through structure and planning.  It also includes adaptive trial design profiles which provide real-life examples of planned adaptations within specific therapeutic areas.

Cull the number of inappropriate candidates that reach Phase 3 by implementing a “drop-the-loser” approach:  Pharmaceutical companies that use “drop-the-loser” approaches to study design can potentially conserve several months of planned study time and pay less per patient when using planned adaptions.  This study explores how pharmaceutical and biotech companies are using these studies — and their results compared to non-adaptive phase 1 trials.

Strategically plan and execute adaptive design clinical trials:  Although simple adaptive trial applications during early-stage clinical research are growing somewhat familiar, regulatory agencies are less well-versed in more complex study designs.   The data and qualitative analysis in this study provide necessary steps toward planning successful adaptive trials.  It also analyzes which development phase and adaption types that clinical development teams prefer.

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

Examples of Companies that Have Participated in this Survey:

Companies that participated in our report adaptive design clinical trials.

Excerpt from Adaptive Design Clinical Trials

Adaptive trial designs have remained an ongoing topic of discussion for regulators and life science teams over the past decade. Broadly, adaptive trial designs enable clinical project teams to prospectively plan adjustments to clinical trial parameters such as patient sample size and number of clinical dosing arms. Adaptive trials may incorporate stopping rules that allow companies to discontinue clinical research based on a demonstrated lack of product efficacy. Alternately, studies may incorporate allocation rules that shift study participants from unsuccessful trial arms to more successful ones.

Much of the industry’s conversation about adaptive trials centers on balancing their advantages against their challenges. Many industry audiences — from regulators to life science companies — argue the merits of adaptive trial designs during early stage research. Even so, when leveraged appropriately, adaptive trial designs may also help trial sponsors generate and improve dose selection schemes during Phase 3. Moreover, from a resourcing standpoint, the Tufts Center for the Study of Drug Development suggests that using simple adaptions that halt studies based on futility may reduce trial durations. In turn, shortening trials can save sponsors hundreds of millions annually in aggregate costs.

Table Of Contents

8             Executive Summary

10           Adaptive Trial Design Studies: Key Recommendations for Success

19           Adaptive Trial Design in Today’s Drug Development Landscape

23           Life Science Executives’ Experiences with Adaptive Strategies

34           Benchmarking Adaptive Design Strategies in Current Clinical Trials

43           Expanding Adaptive Trial Design Through Structure and Resources

73           Strategically Planning and Executing Clinical Studies with Adaptive Trial Design

80           Align Adaptive Trial Decision Making with Corporate Strategy

85           Overcoming Challenges in Implementing Adaptive Trials

93           Adaptive Trial Design Profiles

CHARTS AND GRAPHICS

8             Executive Summary

10           Figure E.1: Sponsor Organization Perspectives: Using Adaptive Studies in Early-Stage Studies* Helps Companies Reduce Phase 3 Failures

10           Adaptive Trial Design Studies: Key Recommendations For Success

19           Adaptive Trial Design in Today’s Drug Development Landscape

23           Life Science Executives’ Experiences with Adaptive Strategies

24           Figure 1.1: Clinical Responsibility Level: All Surveyed Executives from Sponsor Organizations

25           Figure 1.2: Level of Familiarity with Adaptive Trial Designs: All Surveyed Executives from Sponsor Organizations

26           Figure 1.3: Scope of Adaptive Trial Design Responsibility: All Surveyed Executives from Sponsor Organizations

28           Figure 1.4: Around the Industry: Perspectives on Adaptive Trial Design

30           Figure 1.5: Sponsor Organization Perspectives: Using Adaptive Studies in Early-Stage Studies* Helps Companies Reduce Phase 3 Failures

31           Figure 1.6: Sponsor Organization Perspectives: Adaptive Trial Designs May Be More Expensive at Study Start-Up but May Yield Higher Cost Savings for the Drug Development Program

34           Benchmarking Adaptive Design Strategies in Current Clinical Trials

35           Figure 1.7: Average Likelihood of Adjusting Specific Clinical Trial Parameters: All Surveyed Trial      Sponsor Teams

36           Figure 1.8: Total Trials v. Adaptive Trials in 2015: Autoimmune and Immunology

37           Figure 1.9: Total Trials v. Adaptive Trials in 2015: Cardiovascular and Cardio and Thrombosis

38           Figure 1.10: Total Trials v. Adaptive Trials in 2015: CNS and Neurology

39           Figure 1.11: Total Trials v. Adaptive Trials in 2015: Oncology

40           Figure 1.12: Total Trials v. Adaptive Trials in 2015: Surgical and Non-Surgical Devices

41           Figure 1.13: Total Trials v. Adaptive Trials in 2015: Other Therapeutic Areas

43           Expanding Adaptive Trial Design Through Structure and Resources

46           Figure 2.1: Adaptive Trial Design Structure: All Surveyed Trial Sponsor Teams

48           Figure 2.2: Level of Clinical Development Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

48          Figure 2.3: Level of Clinical Operations Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

49           Figure 2.4: Level of Statistics/Biostatistics Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

50           Figure 2.5: Level of Data Management Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

50           Figure 2.6: Level of Drug Safety Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

51           Figure 2.7: Level of Medical/Scientific Affairs Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

52           Figure 2.8: Level of Contract Management Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

52          Figure 2.9: Level of Regulatory Affairs Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

53           Figure 2.10: Level of Traditional Monitoring Groups’ Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

54           Figure 2.11: Level of Clinical Trial Supplies Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

55           Figure 2.12: Level of Risk-Based Monitoring Groups’ Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

58           Figure 2.13: Average Cost per Patient: Non-Adaptive, Phase 1 Studies

59           Figure 2.14: Average Cost per Patient: Adaptive, Non-Oncology Phase 1 Studies

60           Figure 2.15: Average Cost per Patient: Adaptive, Oncology Phase 1 Studies

61           Figure 2.16: Average Cost per Patient: Non-Adaptive, Phase 2 Studies

63           Figure 2.17: Average Cost per Patient: Adaptive, Non-Oncology Phase 2 Studies

65           Figure 2.18: Average Cost per Patient: Adaptive, Oncology Phase 2 Studies

66           Figure 2.19: Average Cost per Patient: Non-Adaptive, Phase 3 Studies

67           Figure 2.20: Average Cost per Patient: Non-Adaptive, Phase 4 Studies

69           Figure 2.21: Average Cost per Patient: Adaptive, Oncology Phase 3 Studies

71           Figure 2.22: Level of CRO/Vendor Involvement in Clinical Studies: All Surveyed Trial Sponsor Teams

73           Strategically Planning and Executing Clinical Studies with Adaptive Trial Design

80           Align Adaptive Trial Decision Making with Corporate Strategy

85           Overcoming Challenges in Implementing Adaptive Trials

80           Figure 3.1: Sponsor Organization Perspectives: Using Simple Adaptive Trial Designs Across an Entire Portfolio Is More Beneficial Than Using Complicated Designs in a Few, Pre-Selected Studies

82           Figure 3.2: Sponsor Organization Perspectives: Using Adaptive Trial Designs in Phases 1 and 2 Provides More Benefits and Poses Less Risk Than Using Similar Trials in Phase 3

83           Figure 3.3: Sponsor Organization Perspectives: Companies Should Concentrate Their Use of Complex Adaptive Trial Designs on Early-Stage Studies*

84           Figure 3.4: Sponsor Organization Perspectives: Companies Should Concentrate on Using Simple Adaptive Trial Designs for Phases 2 and 3

86           Figure 3.5: Average Rating of Planning-Based Adaptive Trial Design Challenges: All Surveyed Trial Sponsor Teams

87           Figure 3.6: Average Rating of Execution-Based Adaptive Trial Design Challenges: All Surveyed Trial Sponsor Teams

93           Adaptive Trial Design Profiles

98           Figure 4.1: CNS Adaptive Trial Designs: Top 50 Company 2 (Global Team)

99           Figure 4.2: CNS Adaptive Trial Designs: Top 50 Company 2 (Global Team) – Phase 2 General Information

100        Figure 4.3: CNS Adaptive Trial Designs: Top 50 Company 2 (Global Team) – Phase 2 Trial Resources

101        Figure 4.4: CNS Adaptive Trial Designs: Top 10 Company 1 (Global Team)

102        Figure 4.5: CNS Adaptive Trial Designs: Top 10 Company 1 (Global Team) – Phase 2 General Information

105        Figure 4.6: Oncology Adaptive Trial Designs: Biotech Company 8 (Global Team)

106        Figure 4.7: Oncology Adaptive Trial Designs: Biotech Company 8 (Global Team) – Phase 1 General Information

107        Figure 4.8: Oncology Adaptive Trial Designs: Biotech Company 8 (Global Team) – Phase 1 Trial Resources

108        Figure 4.9: Oncology Adaptive Trial Designs: Biotech Company 8 (Global Team) – Phase 2 General Information

109        Figure 4.10: Oncology Adaptive Trial Designs: Biotech Company 8 (Global Team) – Phase 2 Trial Resources

110        Figure 4.11: Oncology Adaptive Trial Designs: Biotech Company 8 (Global Team) – Phase 3 General Information

111        Figure 4.12: Oncology Adaptive Trial Designs: Biotech Company 8 (Global Team) – Phase 3 Trial Resources

112        Figure 4.13: Oncology Adaptive Trial Designs: Diagnostic Company 11 (Global Team)

113        Figure 4.14: Oncology Adaptive Trial Designs: Biotech Company 10 (Oncology Business Unit)

114        Figure 4.15: Oncology Adaptive Trial Designs: Biotech Company 10 (Oncology Business Unit) – Phase 1 General Information

115        Figure 4.16: Oncology Adaptive Trial Designs: Biotech Company 10 (Oncology Business Unit) -Phase 1 Trial Resources

116        Figure 4.17: Oncology Adaptive Trial Designs: Biotech Company 10 (Oncology Business Unit) – Phase 2 General Information

117        Figure 4.18: Oncology Adaptive Trial Designs: Biotech Company 10 (Oncology Business Unit) -Phase 2 Trial Resources Part 1

118        Figure 4.19: Oncology Adaptive Trial Designs: Biotech Company 10 (Oncology Business Unit) -Phase 2 Trial Resources Part 2

119        Figure 4.20: Oncology Adaptive Trial Designs: Biotech Company 5 (Global Team)

120        Figure 4.21: Oncology Adaptive Trial Designs: Biotech Company 5 (Global Team) – Phase 1 General Information

121        Figure 4.22: Oncology Adaptive Trial Designs: Biotech Company 5 (Global Team) – Phase 1 Trial Resources

122        Figure 4.23: Oncology Adaptive Trial Designs: Biotech Company 5 (Global Team) – Phase 2 General Information

123        Figure 4.24: Oncology Adaptive Trial Designs: Biotech Company 5 (Global Team) – Phase 2 Trial Resources Part 1

124        Figure 4.25: Oncology Adaptive Trial Designs: Biotech Company 5 (Global Team) – Phase 2 Trial Resources Part 2

125        Figure 4.26: Oncology Adaptive Trial Designs: Biotech Company 5 (Global Team) – Phase 3 General Information

126         Figure 4.27: Oncology Adaptive Trial Designs: Biotech Company 5 (Global Team) – Phase 3 Trial Resources

127        Figure 4.28: Oncology Adaptive Trial Designs: Biotech Company 6 (Global Team)

128        Figure 4.29: Oncology Adaptive Trial Designs: Biotech Company 6 (Global Team) – Phase 1 General Information

129        Figure 4.30: Oncology Adaptive Trial Designs: Biotech Company 6 (Global Team) – Phase 2 General Information

130        Figure 4.31: Oncology Adaptive Trial Designs: Biotech Company 7 (Global Team)

132        Figure 4.32: Hematology Adaptive Trial Designs: Top 50 Company 3 (Global Team)

133        Figure 4.33: Hematology Adaptive Trial Designs: Top 50 Company 3 (Global Team) – Phase 1 General Information

134        Figure 4.34: Hematology Adaptive Trial Designs: Top 50 Company 3 (Global Team) – Phase 1 Trial Resources

135        Figure 4.35: Infectious Diseases Adaptive Trial Designs: Small Pharma Company 4 (Global Team)

136        Figure 4.36: Infectious Diseases Adaptive Trial Designs: Small Pharma Company 4 (Global Team) – Phase 1 General Information

137        Figure 4.37: Infectious Diseases Adaptive Trial Designs: Small Pharma Company 4 (Global Team) – Phase 1 Trial Resources

138        Figure 4.38: Infectious Diseases Adaptive Trial Designs: Small Pharma Company 4 (Global Team) – Phase 2 General Information

139        Figure 4.39: Infectious Diseases Adaptive Trial Designs: Small Pharma Company 4 (Global Team) – Phase 2 Trial Resources

140        Figure 4.40: Medical Devices (Non-Surgical) Adaptive Trial Designs: Diagnostic Company 11 (Global Team)

141        Figure 4.41: Medical Devices (Non-Surgical) Adaptive Trial Designs: Diagnostic Company 11 (Global Team) – First-in-Man General Information

142        Figure 4.42: Medical Devices (Non-Surgical) Adaptive Trial Designs: Diagnostic Company 11 (Global Team) – Feasibility General Information

143        Figure 4.43: Medical Devices (Non-Surgical) Adaptive Trial Designs: Diagnostic Company 11 (Global Team) – Pivotal General Information

144        Figure 4.44: Medical Devices (Non-Surgical) Adaptive Trial Designs: Diagnostic Company 11 (Global Team) – Post-Launch General Information

145        Figure 4.45: Medical Devices (Surgical) Adaptive Trial Designs: Device Company 12 (Global Team)

146        Figure 4.46: Medical Devices (Surgical) Adaptive Trial Designs: Device Company 12 (Global Team) – Pivotal General Information

147        Figure 4.47: Medical Devices (Surgical) Adaptive Trial Designs: Device Company 12 (Global Team) – Post-Launch General Information

148        Figure 4.48: Nephrology Adaptive Trial Designs: Small Pharma Company 9 (Global Team)

149        Figure 4.49: Nephrology Adaptive Trial Designs: Small Pharma Company 9 (Global Team) – Phase 2 General Information

150        Figure 4.50: Nephrology Adaptive Trial Designs: Small Pharma Company 9 (Global Team) – Phase 3 General Information