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臨床開発・治験業務:プロトコル設計・患者1人当たりのコストのベンチマーク

Clinical Development and Trial Operations: Protocol Design and Cost Per Patient Benchmarks

発行 Cutting Edge Information 商品コード 290984
出版日 ページ情報 英文 221 Pages
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臨床開発・治験業務:プロトコル設計・患者1人当たりのコストのベンチマーク Clinical Development and Trial Operations: Protocol Design and Cost Per Patient Benchmarks
出版日: 2013年11月30日 ページ情報: 英文 221 Pages
概要

当レポートは、新しい医療環境で治験業務を改善するためのガイドであり、22の治療領域における460件以上の治験データに基づいて最先端の情報を分析したもので、試験スケジュール・プロトコル開発、スタッフィング、コスト、ベンダー選定、サイト管理など主要指標に注目しており、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

  • 調査方法
  • 定義

試験構造と臨床戦略の調整

  • 規模の経済を維持するための専用臨床構造の構築

臨床チームスタッフィングの再定義・アウトソーシング意思決定

  • スタッフィングと試験目的・社内機能の調整
  • 臨床チームのスタッフィング:治療領域別
  • ベンダー能力の最大化・サードパーティーの支援
  • 関係
  • CROの募集:形式的なベンダー選定プロセスの調査

プロトコル設計・サイト管理

  • 患者中心のプロトコル設計
  • 戦略的なサイト選定

効率的な治験の実行

  • 試験期間
  • 患者募集の強化
  • 治験プロセス:重要なマイルストーンを達成するためのスケジュール
  • 高い患者保持率の維持

治験予算・患者1人当たりのコスト

  • 臨床データの需要が予算増加を後押し
  • 治験コストのベンチマーク:治療領域別

図表

目次
Product Code: PH192

Keeping studies on track while containing costs is a critical issue for clinical teams as they tackle development in a rigorous regulatory and reimbursement climate. Payers and regulators demand more data throughout drug development, and the need to prove value is paramount. Clinical groups must build stringent safety, efficacy and health economic endpoints into early-stage trial protocols - adding months to the timeline as costs reach unprecedented levels.

This report is an all-in-one guide to improving trial operations in the new healthcare environment. Cutting Edge Information analysts developed this research from data on over 460 trials in 22 therapeutic areas. Key performance metrics focus on trial timelines and protocol development, staffing, costs, vendor selection, site management, and more to empower trial teams to:

Boost patient recruitment and retention

Uncover simple strategies to create a patient-centric protocol that gains doctors' support and reduces burdens for patients and caregivers. Set recruitment targets, develop detailed action plans for site recruitment and identify weaknesses in trial design and protocol feasibility.

Set budgets and control costs

Understand market forces affecting clinical trial budgets, and analyze study costs - including overall trial costs and per-patient trial costs - for 22 therapeutic areas across Phases 1, 2, 3 and 4.

Align staffing with site-level demands

Make the most of trial staffing with benchmarks for patients-per-CRA and Sites per- CRA ratios in 16 therapeutic areas. To achieve a balance of in-house and outsourced personnel, follow field-tested steps for implementing a rigorous vendor selection process.

Reduce delays and keep trials on track

Trials inevitably experience delays - but preparing for such speed bumps keeps overall timelines intact. Use our benchmarks to pinpoint problem areas at key trial milestones, and follow best practices to direct improvement efforts.

Table of Contents

Executive Summary

  • Study Methodology
  • Study Definitions

Aligning Trial Structure with Clinical Strategy

  • Build Dedicated Clinical Structures to Preserve Economies of Scale

Refining Clinical Team Staffing and Outsourcing Decision Making

  • Align Staffing with Trial Objectives and In-House Capabilities
  • Clinical Teams' Staffing by Therapeutic Area
  • Maximizing Vendor Capabilities and Facilitating Third- Party
  • Relationships
  • Recruiting CROs: A Look at the Formal Vendor Selection Process

Protocol Design and Site Management

  • Patient-Centric Protocol Design
  • Strategic Site Selection

Conducting Efficient Clinical Trials

  • Trial Duration
  • Boosting Patient Recruitment
  • Clinical Trial Progress: Timelines to Achieve Key Milestones
  • Maintaining High Patient Retention Rates

Clinical Trial Budgets and Per-Patient Costs

  • Demand for Clinical Data Drives Budgets Higher
  • Benchmarking Clinical Trial Costs by Therapeutic Area

CHARTS AND GRAPHICS

Executive Summary

  • Figure E.1: Average Per-Patient Clinical Trial Costs, by Phase
  • Figure E.2: Average Delay for Clinical Trials, by Phase
  • Figure E.3: Patient Screening Rates, by Phase
  • Figure E.4: Average Patient Retention Rate, by Phase
  • Figure E.5: Percentage of Companies Outsourcing Some Portion of Clinical Trial Costs
  • Figure E.6: Average Ratio of Patients per CRA, by Development Stage
  • Figure E.7: Average Ratio of Investigator Sites per CRA, by Development Stage

Aligning Trial Structure with Clinical Strategy

Build Dedicated Clinical Structures to Preserve Economies of Scale

  • Figure 1.1: Companies' Clinical Operations Structures
  • Figure 1.2: Number of Therapeutic Areas Studied, by Company Type
  • Figure 1.3: Number of Companies Conducting Clinical Trials, by Therapeutic Area
  • Figure 1.4: Clinical Team Structure: Company E (Large Pharma)
  • Figure 1.5: Clinical Team Structure: Company I (Mid-Sized Pharma)
  • Figure 1.6: Clinical Team Structure: Company L (Small Pharma)
  • Figure 1.7: Team Structure: Company K (Biotech)
  • Figure 1.8: Clinical Team Structure: Company A (CRO)

Developing Robust Clinical Team Staffing and Outsourcing Strategies

Align Staffing with Trial Objectives and In-House Capabilities

  • Figure 2.1: Average Ratio of Patients per CRA, by Phase
  • Figure 2.2: Average Ratio of Investigator Sites per CRA, by Phase

Clinical Teams' Staffing by Therapeutic Area

  • Figure 2.3: Trials' Total CRA Staffing, by Therapeutic Area
  • Figure 2.4: Patients per CRA in Cardiovascular Trials
  • Figure 2.5: Sites per CRA in Cardiovascular Trials
  • Figure 2.6: Patients per CRA in Central Nervous System Trials
  • Figure 2.7: Sites per CRA in Central Nervous System Trials
  • Figure 2.8: Patients per CRA in Dermatology Trials
  • Figure 2.9: Sites per CRA in Dermatology Trials
  • Figure 2.10: Patients per CRA in Diabetes (Type 2) Trials
  • Figure 2.11: Sites per CRA in Diabetes (Type 2) Trials
  • Figure 2.12: Patients per CRA in Endocrinology Trials
  • Figure 2.13: Sites per CRA in Endocrinology Trials
  • Figure 2.14: Patients per CRA in Gastroenterology Trials
  • Figure 2.15: Sites per CRA in Gastroenterology Trials
  • Figure 2.16: Patients per CRA in Hematology Trials
  • Figure 2.17: Sites per CRA in Hematology Trials
  • Figure 2.18: Patients per CRA in Infectious Disease Trials
  • Figure 2.19: Sites per CRA in Infectious Disease Trials
  • Figure 2.20: Patients per CRA in Medical Device Trials
  • Figure 2.21: Sites per CRA in Medical Device Trials
  • Figure 2.22: Patients per CRA in Musculoskeletal Trials
  • Figure 2.23: Sites per CRA in Musculoskeletal Trials
  • Figure 2.24: Patients per CRA in Early-Stage Oncology Trials
  • Figure 2.25: Patients per CRA in Late-Stage Oncology Trials
  • Figure 2.26: Sites per CRA in Early-Stage Oncology Trials
  • Figure 2.27: Sites per CRA in Late-Stage Oncology Trials
  • Figure 2.28: Patients per CRA in Respiratory Trials
  • Figure 2.29: Sites per CRA in Respiratory Trials
  • Figure 2.30: Patients per CRA in Rheumatology Trials
  • Figure 2.31: Sites per CRA in Rheumatology Trials
  • Figure 2.32: Patients per CRA in Urology Trials
  • Figure 2.33: Sites per CRA in Urology Trials
  • Figure 2.34: Patients per CRA in Women's Health Trials
  • Figure 2.35: Sites per CRA in Women's Health Trials

Maximizing Vendor Capabilities and Facilitating Third- Party

  • Relationships
  • Figure 2.36: Percentage of Companies Outsourcing Some Portion of Clinical Trial Costs
  • Figure 2.37: Average Percentage of Total Trial Cost Outsourced, by Company Type
  • Figure 2.38: Average Number of Outsourced Staff, by Subgroup/Team
  • Figure 2.39: Percentage of Companies that Outsource Clinical Operations Staffing
  • Figure 2.40: Average Percentage of Total Trial Cost Outsourced, by Phase
  • Figure 2.41: Average Percentage of Total Trial Cost Outsourced, by Therapeutic Area

Recruiting CROs: A Look at the Formal Vendor Selection Process

Protocol Design and Site Management

Patient-Centric Protocol Design

  • Figure 3.1: Time Spent (in Months) Planning Protocol, by Phase
  • Figure 3.2: Time (in Months) to Earn IRB/Ethics Approval, by Phase
  • Figure 3.3: Number of Office Visits Required by Protocol, by Phase
  • Figure 3.4: Number of Office Visits Required by Protocol, by Therapeutic Area
  • Figure 3.5: Number of Amendments per Protocol, by Phase
  • Figure 3.6: Number of Amendments per Protocol by Therapeutic Area
  • Figure 3.7: Patient Screening Rates, by Phase
  • Figure 3.8: Patient Screening Rates by Therapeutic Area
  • Figure 3.9: Trials Using Adaptive Design by Phase

Strategic Site Selection

  • Figure 3.10: Average Number of Investigator Sites Used, by Phase
  • Figure 3.11: Average Ratio of Patients per Investigator Site, by Phase
  • Figure 3.12: Average Ratio of Patients per Site by Therapeutic Area
  • Figure 3.13: Percentage of Non-Performing Sites, by Phase
  • Figure 3.14: Percentage of Non-Performing Sites, by Therapeutic Area

Conducting Efficient Clinical Trials

Trial Duration

  • Figure 4.1: Average Duration (in Months) of Clinical Trials, by Phase
  • Figure 4.2: Average Delay for Clinical Trials, by Phase
  • Figure 4.3: Average Delay for Clinical Trials, by Therapeutic Area

Boosting Patient Recruitment

  • Figure 4.4: Average Number of Patients Enrolled in Clinical Trials, by Phase

Clinical Trial Progress: Timelines to Achieve Key Milestones

  • Figure 4.5: Average Number of Months to Achieve Key Trial Milestones: Phase 1
  • Figure 4.6: Average Delay in Achieving Trial Milestones: Phase 1
  • Figure 4.7: Average Number of Months to Achieve Key Trial Milestones: Phase 2
  • Figure 4.8: Average Delay in Achieving Trial Milestones: Phase 2
  • Figure 4.9: Average Number of Months to Achieve Key Trial Milestones: Phase 3a
  • Figure 4.10: Average Delay in Achieving Trial Milestones: Phase 3a
  • Figure 4.11: Average Number of Months to Achieve Key Trial Milestones: Phase 3b
  • Figure 4.12: Average Delay in Achieving Trial Milestones: Phase 3b
  • Figure 4.13: Average Number of Months to Achieve Key Trial Milestones: Phase 4
  • Figure 4.14: Average Delay in Achieving Trial Milestones: Phase 4

Maintaining High Patient Retention Rates

  • Figure 4.15: Average Patient Retention Rate, by Phase

Clinical Trial Budgets and Per-Patient Costs

Demand for Clinical Data Drives Budgets Higher

  • Figure 5.1: Average Total Cost for Clinical Trials, by Phase: All Therapeutic Areas
  • Figure 5.2: Average Per-Patient Clinical Trial Costs: All Therapeutic Areas

Benchmarking Clinical Trial Costs by Therapeutic Area

  • Figure 5.3: Per-Patient Clinical Trial Costs: Arthritis (Non-Rheumatic)
  • Figure 5.4: Total Cost for Clinical Trials: Early-Stage Arthritis (Non-Rheumatic)
  • Figure 5.5: Total Cost for Clinical Trials: Late-Stage Arthritis (Non-Rheumatic)
  • Figure 5.6: Total Cost for Clinical Trials: Early-Stage Autoimmune
  • Figure 5.7: Total Cost for Clinical Trials: Late-Stage Autoimmune
  • Figure 5.8: Total Cost for Clinical Trials: Cardiology and Thrombosis
  • Figure 5.9: Per-Patient Clinical Trial Costs: Cardiovascular Diseases
  • Figure 5.10: Total Cost for Clinical Trials: Early-Stage Cardiovascular Diseases
  • Figure 5.11: Total Cost for Clinical Trials: Late-Stage Cardiovascular Diseases
  • Figure 5.12: Per-Patient Clinical Trial Costs: Early-Stage Central Nervous System
  • Figure 5.13: Per-Patient Clinical Trial Costs: Late-Stage Central Nervous System
  • Figure 5.14: Total Cost for Clinical Trials: Early-Stage Central Nervous System
  • Figure 5.15: Total Cost for Clinical Trials: Late-Stage Central Nervous System
  • Figure 5.16: Per-Patient Clinical Trial Costs: Dermatology
  • Figure 5.17: Total Cost for Clinical Trials: Early-Stage Dermatology
  • Figure 5.18: Total Cost for Clinical Trials: Late-Stage Dermatology
  • Figure 5.19: Total Cost for Clinical Trials: Diabetes (Type 1)
  • Figure 5.20: Per-Patient Clinical Trial Costs: Diabetes (Type 2)
  • Figure 5.21: Total Cost for Clinical Trials: Early-Stage Diabetes (Type 2)
  • Figure 5.22: Total Cost for Clinical Trials: Late-Stage Diabetes (Type 2)
  • Figure 5.23: Per-Patient Clinical Trial Costs: Endocrinology/Metabolic Diseases (Non-Diabetes)
  • Figure 5.24: Total Cost for Clinical Trials: Early-Stage Endocrinology/Metabolic Diseases (Non-Diabetes)
  • Figure 5.25: Total Cost for Clinical Trials: Late-Stage Endocrinology/Metabolic Diseases (Non-Diabetes)
  • Figure 5.26: Per-Patient Clinical Trial Costs: Gastroenterology
  • Figure 5.27: Total Cost for Clinical Trials: Early-Stage Gastroenterology
  • Figure 5.28: Total Cost for Clinical Trials: Late-Stage Gastroenterology
  • Figure 5.29: Per-Patient Clinical Trial Costs: Hematology
  • Figure 5.30: Total Cost for Clinical Trials: Early-Stage Hematology
  • Figure 5.31: Total Cost for Clinical Trials: Late-Stage Hematology
  • Figure 5.32: Total Cost for Clinical Trials: Early-Stage Immunology/Vaccines (Non-Autoimmune)
  • Figure 5.33: Total Cost for Clinical Trials: Late-Stage Immunology/Vaccines (Non-Autoimmune)
  • Figure 5.34: Per-Patient Clinical Trial Costs: Infectious Disease
  • Figure 5.35: Total Cost for Clinical Trials: Early-Stage Infectious Disease
  • Figure 5.36: Total Cost for Clinical Trials: Late-Stage Infectious Disease
  • Figure 5.37: Total Cost for Clinical Trials: Early-Stage Inflammation (General)
  • Figure 5.38: Total Cost for Clinical Trials: Late-Stage Inflammation (General)
  • Figure 5.39: Total Cost for Clinical Trials: Mental Health/Psychology
  • Figure 5.40: Per-Patient Clinical Trial Costs: Musculoskeletal
  • Figure 5.41: Total Cost for Clinical Trials: Early-Stage Musculoskeletal
  • Figure 5.42: Total Cost for Clinical Trials: Late-Stage Musculoskeletal
  • Figure 5.43: Per-Patient Clinical Trial Costs: Phase 1 Oncology
  • Figure 5.44: Per-Patient Clinical Trial Costs: Phase 2 Oncology
  • Figure 5.45: Per-Patient Clinical Trial Costs: Phase 3 Oncology
  • Figure 5.46: Total Cost for Clinical Trials: Phase 1 Oncology
  • Figure 5.47: Total Cost for Clinical Trials: Phase 2 Oncology
  • Figure 5.48: Total Cost for Clinical Trials: Phase 3 Oncology
  • Figure 5.49: Total Cost for Clinical Trials: Phase 4 Oncology
  • Figure 5.50: Per-Patient Clinical Trial Costs: Respiratory
  • Figure 5.51: Total Cost for Clinical Trials: Early-Stage Respiratory
  • Figure 5.52: Total Cost for Clinical Trials: Late-Stage Respiratory
  • Figure 5.53: Per-Patient Clinical Trial Costs: Rheumatic Diseases/Rheumatology
  • Figure 5.54: Total Cost for Clinical Trials: Early-Stage Rheumatic Diseases/Rheumatology
  • Figure 5.55: Total Cost for Clinical Trials: Late-Stage Rheumatic Diseases/Rheumatology
  • Figure 5.56: Per-Patient Clinical Trial Costs: Urology
  • Figure 5.57: Total Cost for Clinical Trials: Early-Stage Urology
  • Figure 5.58: Total Cost for Clinical Trials: Late-Stage Urology
  • Figure 5.59: Total Cost for Clinical Trials: Virology
  • Figure 5.60: Per-Patient Clinical Trial Costs: Women's Health
  • Figure 5.61: Total Cost for Clinical Trials: Early-Stage Women's Health
  • Figure 5.62: Total Cost for Clinical Trials: Late-Stage Women's Health
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