市場調査レポート

臨床薬理プログラムの最適化:第I相試験のコストドライバー

Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials

発行 Cutting Edge Information 商品コード 258253
出版日 ページ情報 英文 112 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=102.18円で換算しております。
Back to Top
臨床薬理プログラムの最適化:第I相試験のコストドライバー Optimizing Clinical Pharmacology Programs: Cost-Drivers of Phase I Trials
出版日: 2013年01月01日 ページ情報: 英文 112 Pages
概要

第I相試験は化合物が法的承認を受けるための極めて重要なステップであり、臨床チームは新たな治験薬剤のそれぞれが大規模な治験の段階に進めるよう取り組んでいます。しかし課題は数多くあり、限られた予算やスケジュールや採用、サイトの変動などで発生するさまざまな問題がコスト上の圧力となっています。

当レポートでは、第I相試験の管理における不確定要素とその影響因子について調査分析し、第I相試験のチーム構成、予算とコストドライバー、タイムライン、患者採用、ベンダー管理などに関する比較とベストプラクティスをまとめ、概略下記の構成でお届けいたします。

エグゼクティブサマリー

  • 調査手法
  • 調査の定義
  • 臨床開発:主な動向・提言

早期臨床試験の構造・人材

  • 第I相試験:管理グループの構成
  • 第I相試験およびそれ以降への製品の推進

第I相試験:予算・コストドライバー

  • 第I相試験の予算
  • 第I相試験のコストドライバー

試験期間・患者採用のマイルストーン

  • 第I相試験の期間の計画と実際の比較
  • 第I相試験の平均期間

第I相試験:アウトソーシングとベンダー管理

  • アウトソーシング戦略
  • ベンダー関係管理

図表

目次
Product Code: PH173

Manage Phase I Cost-Drivers to Move Compounds through Early-Stage Trials

Phase I is a pivotal step in a compound's journey toward regulatory approval, as clinical teams shepherd each new wave of investigational medicines toward large-scale trials.

The challenges are increasing. Cost pressures stretch limited budgets along with issues involving timelines, recruitment, sites and more - which rise and fall according to shifting sets of variables. Phase I protocol, once predictable, now must account for rapid expansion into more complicated areas, such as oncology and orphan diseases.

Use this report to address the major factors behind uncertainty in Phase I trial management. Its benchmarks and best practices explore Phase I clinical team resources, trial timelines, challenges and vendor management:

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 I planning to prevent delays - and propel teams toward trial completion

Set defined milestones and explore trial 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 I trials across therapeutic areas. Lastly, follow strategic recommendations for vendor selection and management.

Table of Contents

Executive Summary

  • Study Methodology
  • Study Definitions
  • Clinical Operations: Key Trends and Recommendations

Early-Stage Clinical Structure and Trial Staffing

  • Phase 1 - Management Group Structures
  • Advancing Products into and Beyond Phase 1

Phase 1 - Trial Budgets and Cost-Drivers

  • Phase 1 Trial Budgets
  • Phase 1 Trial Cost-Drivers

Trial Duration and Patient Recruitment Milestones

  • Comparing Planned Versus Actual Phase 1 Trial Duration
  • Average Phase 1 Trial Duration

Phase 1 - Outsourcing and Vendor Management

  • Outsourcing Strategy
  • Vendor Relationship Management

CHARTS AND GRAPHICS

Executive Summary

  • Figure E.1: Average Cost per Patient in Phase 1 Clinical Trials by Number of Patient Visits in Protocol
  • Clinical Operations: Key Trends and Recommendations
  • Figure E.2: Average Time Dedicated to Each Activity in Phase 1
  • Figure E.3: Advancing Products into Phase 1: Company A
  • Figure E.4: Average Months Until All Sites Active by Number of Sites

Early-Stage Clinical Structure and Trial Staffing

  • Phase 1 Management Group Structures
  • Figure 1.1: Company F's Phase 1 Team Structure
  • Figure 1.2: Company B's Phase 1 Team Structure
  • Figure 1.3: Company G's In-House Clinical Development Team
  • Figure 1.4: Company A's Phase 1 Team Structure
  • Figure 1.5: Average Sponsor Headcount for All Phase 1 Trials
  • Figure 1.6: Sponsor Headcount for Oncology Phase 1 Trials
  • Figure 1.7: Sponsor Headcount for Cardiovascular Phase 1 Trials
  • Figure 1.8: Sponsor Headcount for Central Nervous System/Neurology Phase 1 Trials
  • Figure 1.9: Sponsor Headcount for Women's Health Phase 1 Trials
  • Figure 1.10: Sponsor Headcount for Gastroenterology Phase 1 Trials
  • Figure 1.11: Sponsor Headcount Therapeutics with One Reported Phase 1 Trial
  • Advancing Products into and Beyond Phase 1
  • Figure 1.12: Advancing Products into Phase 1: Company E
  • Figure 1.13: Advancing Products into Phase 1: Company A

Phase 1 Trial Budgets and Cost-Drivers

  • Phase 1 Trial Budgets
  • Figure 2.1: Average Trial Costs for All Phase 1 Trials, by Therapeutic Area
  • Figure 2.2: Total Costs for Phase 1 Oncology Clinical Trials
  • Figure 2.3: Total Costs for Phase 1 Cardiology Clinical Trials
  • Figure 2.4: Total Costs for Phase 1 Central Nervous System Clinical Trials
  • Figure 2.5: Total Costs for Phase 1 Gastroenterology Clinical Trials
  • Figure 2.6: Total Costs for Phase 1 Women's Health Clinical Trials
  • Figure 2.7: Total Costs for Phase 1 Across Various Therapeutic Areas
  • Figure 2.8: Average Patient Enrollment and Dropout Rate for All Phase 1 Trials
  • Phase 1 Trial Cost-Drivers
  • Figure 2.9: Average Patient Enrollment in Phase 1 Clinical Trials by Therapeutic Area
  • Figure 2.10: Average Patients Completing Phase 1 Clinical Trials, by Therapeutic Area
  • Figure 2.11: Average Patient Dropout Rate in Phase 1 Clinical Trials by Therapeutic Area
  • Figure 2.12: Average Per-Patient Costs in Phase 1 Clinical Trials, by Therapeutic Area
  • Figure 2.13: Average Per-Patient Costs in Phase 1 Oncology Clinical Trials
  • Figure 2.14: Average Per-patient costs in Phase 1 Cardiology Clinical Trials
  • Figure 2.15: Average Per-patient costs in Phase 1 Central Nervous System Clinical Trials
  • Figure 2.16: Average Per-Patient Costs in Phase 1 Gastroenterology Clinical Trials
  • Figure 2.17: Average Number of Patient Visits in Phase 1 Protocol by Therapeutic Area
  • Figure 2.18: Average Cost per Patient in Phase 1 Clinical Trials by Number of Patient Visits in Protocol
  • Figure 2.19: Average Cost Per Patient Per Visit in Phase 1 Clinical Trials by Therapeutic Area
  • Figure 2.20: Average Cost Per Patient Per Visit in Phase 1 Oncology Clinical Trials
  • Figure 2.21: Average Cost Per Patient Per Visit in Phase 1 Cardiology Clinical Trials
  • Figure 2.22: Average Cost Per Patient Per Visit in Phase 1 Central Nervous System Clinical Trials
  • Figure 2.23: Average Cost Per Patient Per Visit in Phase 1 Gastroenterology Clinical Trials
  • Figure 2.24: Average Phase 1 Cost Per Patient by Trial Duration
  • Figure 2.25: Average Cost Per Patient Per Month in Phase 1 Clinical Trials by Therapeutic Area
  • Figure 2.26: Average Cost Per Patient Per Month in Phase 1 Oncology Clinical Trials
  • Figure 2.27: Average Cost Per Patient Per Month in Phase 1 Cardiology Clinical Trials
  • Figure 2.28: Average Cost Per Patient Per Month in Phase 1 Central Nervous System Clinical Trials
  • Figure 2.29: Average Cost Per Patient Per Month in Phase 1 Gastroenterology Clinical Trials

Trial Duration and Patient Recruitment Milestones

  • Comparing Planned Versus Actual Phase 1 Trial Duration
  • Figure 3.1: Planned Versus Actual Phase 1 Trial Milestones
  • Figure 3.2: Planned Duration of Phase 1 Cardiology Clinical Trials
  • Figure 3.3: Actual Duration of Phase 1 Cardiology Clinical Trials
  • Figure 3.4: Planned Duration of Phase 1 Central Nervous System Clinical Trials
  • Figure 3.5: Actual Duration of Phase 1 Central Nervous System Clinical Trials
  • Figure 3.6: Planned Duration of Phase 1 Gastroenterology Clinical Trials
  • Figure 3.7: Actual Duration of Phase 1 Gastroenterology Clinical Trials
  • Figure 3.8: Planned Duration of Phase 1 in Women's Health Clinical Trials
  • Phase 1 Trials for Women's Health Kept on Schedule
  • Figure 3.9: Actual Duration of Phase 1 in Women's Health Clinical Trials
  • Figure 3.10: Planned Duration of Phase 1 Oncology Clinical Trials
  • Figure 3.11: Actual Duration of Phase 1 Oncology Clinical Trials
  • Average Phase 1 Trial Duration
  • Figure 3.12: Average Percentage of Time Dedicated to Specific Phase 1 Activities
  • Figure 3.13: Average Percentage of Time Spent Per Clinical Operations Stage for All Phase 1 Trials
  • Figure 3.14: Average Percentage of Time Dedicated to Specific Activities in Phase 1 Cardiology Trials
  • Figure 3.15: Average Percentage of Time Spent Per Clinical Operations Stage for Phase 1 Cardiology Trials
  • Figure 3.16: Average Percentage of Time Dedicated to Specific Activities in Phase 1 Central Nervous System Trials
  • Figure 3.17: Average Percentage of Time Spent Per Clinical Operations Stage for Phase 1 Central Nervous System Trials
  • Figure 3.18: Average Percentage of Time Dedicated to Specific Activities in Phase 1 Diabetes (Type 2) Trials
  • Figure 3.19: Average Percentage of Time Spent Per Clinical Operations Stage for Phase 1 Diabetes (Type 2) Trials
  • Figure 3.20: Average Percentage of Time Dedicated to Specific Activities in Phase 1 Diabetes (Type 2) Trials
  • Figure 3.21: Average Time Spent in Each Clinical Operations Stage for Phase 1 Oncology Trials

Phase 1 Outsourcing and Vendor Management

  • Figure 4.1: Average Percentage of Phase 1 Trial Costs Outsourced
  • Figure 4.2: Average Percentage of Phase 1 Trial Costs Outsourced by Therapeutic Field
  • Outsourcing Strategy
  • Figure 4.3: Percentage of Trials by Number of Sites
  • Figure 4.4: Average Number of Sites Per Trial, by Therapeutic Area
  • Figure 4.5: Percentage of Sites Unable to Recruit Patients for Trials with Multiple Sites
  • Figure 4.6: Percentage of Site Drop Off by Number of Sites
  • Figure 4.7: Average Months Until All Sites Active by Number of Sites
  • Figure 4.8: Average Months Until All Sites Active, by Therapeutic Area
  • Vendor Relationship Management
Back to Top