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癌の治験:創薬資源およびケーススタディ

Oncology Clinical Trials: Drug Development Resources and Case Studies

発行 Cutting Edge Information 商品コード 264527
出版日 ページ情報 英文 211 Pages
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癌の治験:創薬資源およびケーススタディ Oncology Clinical Trials: Drug Development Resources and Case Studies
出版日: 2013年03月15日 ページ情報: 英文 211 Pages
概要

米国の国立癌研究所(NCI)によると、米国では2012年において160万人が新たに癌と診断され、57万7千人が癌に関連して死亡しています。この膨大な数字によって、癌は医薬品研究における最大の治療分野のひとつとなっています。

当レポートでは、主な癌の症状10種以上にわたる癌の臨床試験29件のフェーズ1、2、および3のみに焦点を当て、治験の詳細なケーススタディを提供しており、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

フェーズ1:癌治験

  • フェーズ1:コスト促進因子
  • フェーズ1:スタッフの配属
  • フェーズ1:癌治験のケーススタディ
  • 癌治験A〜K

フェーズ2:癌治験

  • フェーズ2:コスト促進因子
  • フェーズ2:スタッフの配属
  • フェーズ2:癌治験のケーススタディ
  • 癌治験L〜T

フェーズ3:癌治験

  • フェーズ3:コスト促進因子
  • フェーズ3:スタッフの配属
  • フェーズ3:癌治験のケーススタディ
  • 癌治験U〜CC

図表

目次
Product Code: PH180

OVERVIEW

According to the US National Cancer Institute, 2012 saw 1.6 million newly diagnosed cancer cases and 577,000 cancer-related deaths in the US alone. With such staggering numbers, oncology stands as one of the largest therapeutic areas within pharma research. Life science companies spend, on average, $56.3 million and eight years to advance an oncology product from Phase 1 through Phase 3. At every development stage, trial teams contend with key cost-drivers to maintain their budgets and timelines as they push their drugs to the finishing line.

This data-driven report focuses exclusively on Phase 1, 2 and 3 benchmarks for 29 oncology trials across more than 10 primary oncology indications. It includes detailed trial case studies that create comprehensive snapshots to improve oncology trial operations.

Control budgets and accelerate timelines

Benchmark oncology trials of different sizes and durations with individual and average per patient and per patient per month costs for each development phase. Compare average planned and actual trial durations while seeing how trial duration influences total costs - and see how outsourcing can help.

Manage critical cost-drivers

Track the shifting impact of key cost-drivers, such as patient enrollment and trial duration, as a product moves through development. At the same time, see how an adequate number of sites encourages patient enrollment - a critical challenge for any trial.

Right-size your trial teams

Set optimal staffing levels for both CRAs and trial managers to handle trial sites and patients for each development phase - the report showcases average staffing for 12 key positions across all oncology phases. Benchmark metrics such as number of sites per CRA and number of patients per CRA.

Table of Contents

Executive Summary

  • Study Methodology
  • Study Definitions
  • Oncology Clinical Trials: Key Findings

Phase 1 - Oncology Trials

  • Phase 1 - Cost-Drivers
  • Phase 1 - Staffing
  • Phase 1 - Oncology Trial Case Studies
  • Oncology Trial A
  • Oncology Trial B
  • Oncology Trial C
  • Oncology Trial D
  • Oncology Trial E
  • Oncology Trial F
  • Oncology Trial G
  • Oncology Trial H
  • Oncology Trial I
  • Oncology Trial J
  • Oncology Trial K

Phase 2 - Oncology Trials

  • Phase 2 - Cost-Drivers
  • Phase 2 - Staffing
  • Phase 2 - Oncology Trial Case Studies
  • Oncology Trial L
  • Oncology Trial M
  • Oncology Trial N
  • Oncology Trial O
  • Oncology Trial P
  • Oncology Trial Q
  • Oncology Trial R
  • Oncology Trial S
  • Oncology Trial T

Phase 3 - Oncology Trials

  • Phase 3 - Cost-Drivers
  • Phase 3 - Staffing
  • Phase 3 - Oncology Trial Case Studies
  • Oncology Trial U
  • Oncology Trial V
  • Oncology Trial W
  • Oncology Trial X
  • Oncology Trial Y
  • Oncology Trial Z
  • Oncology Trial AA
  • Oncology Trial BB
  • Oncology Trial CC

CHARTS AND GRAPHICS

Executive Summary

  • Figure E.1: Active Oncology Drug Programs, by Indication

Oncology Clinical Trials: Key Findings

  • Figure E.2: Range and Average Cost Per Patient, by Phase
  • Figure E.3: Range and Average Trial Duration, by Phase
  • Figure E.4: Range and Average Number of Patients Per Site, by Phase
  • Figure E.5: Range and Average Number of CRAs, by Phase
  • Figure E.6: Range and Average Number of Sites Per CRA, by Phase

Phase 1 - Oncology Trials

  • Figure 1.1: Phase 1 - Total Trial Costs, by Trial
  • Figure 1.2: Phase 1 - Percentage of Costs Outsourced, by Trial

Phase 1 - Cost-Drivers

  • Figure 1.3: Phase 1 - Average Planned/Actual Patient Enrollment
  • Figure 1.4: Phase 1 - Planned/Actual Patient Enrollment, by Trial
  • Figure 1.5: Patient Enrollment Drives Phase 1 Trial Costs
  • Figure 1.6: Phase 1 - Cost Per Patient, by Trial
  • Figure 1.7: Phase 1 - Trial Duration, by Trial
  • Figure 1.8: Trial Duration Drives Phase 1 Trial Costs
  • Figure 1.9: Phase 1 - Cost Per Patient Per Month

Phase 1 - Staffing

  • Figure 1.10: Average Phase 1 Staffing, by Position
  • Figure 1.11: Phase 1 - Patients Per CRA, by Trial
  • Figure 1.12: Phase 1 - Number of Sites, by Trial
  • Figure 1.13: Number of Patients Per Site, by Trial
  • Figure 1.14: Phase 1 - Sites Per CRA, by Trial

Phase 1 - Oncology Trial Case Studies

  • Oncology Trial A
  • Figure 1.15: Oncology Trial A: Background and Budget
  • Figure 1.16: Oncology Trial A: Cost Metrics and Staffing
  • Figure 1.17: Oncology Trial A: Duration and Enrollment
  • Oncology Trial B
  • Figure 1.18: Oncology Trial B: Background and Budget
  • Figure 1.19: Oncology Trial B: Cost Metrics and Staffing
  • Figure 1.20: Oncology Trial B: Duration and Enrollment
  • Oncology Trial C
  • Figure 1.21: Oncology Trial C: Background and Budget
  • Figure 1.22: Oncology Trial C: Staffing and Enrollment
  • Figure 1.23: Oncology Trial C: Duration
  • Oncology Trial D
  • Figure 1.24: Oncology Trial D: Background and Budget
  • Figure 1.25: Oncology Trial D: Cost Metrics and Staffing
  • Figure 1.26: Oncology Trial D: Duration
  • Oncology Trial E
  • Figure 1.27: Oncology Trial E: Background and Budget
  • Figure 1.28: Oncology Trial E: Cost Metrics and Staffing
  • Figure 1.29: Oncology Trial E: Duration
  • Oncology Trial F
  • Figure 1.30: Oncology Trial F: Background and Budget
  • Figure 1.31: Oncology Trial F: Duration and Enrollment
  • Oncology Trial G
  • Figure 1.32: Oncology Trial G: Background and Budget
  • Figure 1.33: Oncology Trial G: Staffing and Enrollment
  • Figure 1.34: Oncology Trial G: Duration
  • Oncology Trial H
  • Figure 1.35: Oncology Trial H: Background and Budget
  • Figure 1.36: Oncology Trial H: Cost Metrics and Staffing
  • Figure 1.37: Oncology Trial H: Duration and Enrollment
  • Oncology Trial I
  • Figure 1.38: Oncology Trial I: Background and Budget
  • Figure 1.39: Oncology Trial I: Cost Metrics and Staffing
  • Figure 1.40: Oncology Trial I: Duration and Enrollment
  • Oncology Trial J
  • Figure 1.41: Oncology Trial J: Background and Budget
  • Figure 1.42: Oncology Trial J: Cost Metrics and Enrollment
  • Figure 1.43: Oncology Trial J: Duration
  • Oncology Trial K
  • Figure 1.44: Oncology Trial K: Background and Budget
  • Figure 1.45: Oncology Trial K: Staffing
  • Figure 1.46: Oncology Trial K: Duration and Enrollment

Phase 2 - Oncology Trials

  • Figure 2.1: Phase 2 - Total Trial Costs, by Trial
  • Figure 2.2: Phase 2 - Percentage of Costs Outsourced, by Trial

Phase 2 - Cost-Drivers

  • Figure 2.3: Phase 2 - Average Planned/Actual Patient Enrollment
  • Figure 2.4: Phase 2 - Planned/Actual Patient Enrollment, by Trial
  • Figure 2.5: Patient Enrollment Drives Phase 2 Trial Costs
  • Figure 2.6: Phase 2 - Cost Per Patient, by Trial
  • Figure 2.7: Phase 2 - Actual Trial Duration, by Trial
  • Figure 2.8: Trial Duration and Phase 2 Trial Costs
  • Figure 2.9: Phase 2 - Cost Per Patient Per Month

Phase 2 - Staffing

  • Figure 2.10: Average Phase 2 - Staffing, by Position
  • Figure 2.11: Phase 2 - Number of Patients Per CRA
  • Figure 2.12: Phase 2 - Number of Sites, by Trial
  • Figure 2.13: Phase 2 - Number of Patients Per Site, by Trial
  • Figure 2.14: Phase 2 - Number of Sites Per CRA, by Trial

Phase 2 - Oncology Trial Case Studies

  • Oncology Trial L
  • Figure 2.15: Oncology Trial L: Background and Budget
  • Figure 2.16: Oncology Trial L: Cost Metrics and Staffing
  • Figure 2.17: Oncology Trial L: Duration and Enrollment
  • Oncology Trial M
  • Figure 2.18: Oncology Trial M: Background and Budget
  • Figure 2.19: Oncology Trial M: Staffing and Enrollment
  • Figure 2.20: Oncology Trial M: Duration
  • Oncology Trial N
  • Figure 2.21: Oncology Trial N: Background and Budget
  • Figure 2.22: Oncology Trial N: Cost Metrics and Enrollment
  • Figure 2.23: Oncology Trial N: Duration
  • Oncology Trial O
  • Figure 2.24: Oncology Trial O: Background and Budget
  • Figure 2.25: Oncology Trial O: Staffing
  • Figure 2.26: Oncology Trial O: Duration and Enrollment
  • Oncology Trial P
  • Figure 2.27: Oncology Trial P: Background and Budget
  • Figure 2.28: Oncology Trial P: Staffing and Enrollment
  • Figure 2.29: Oncology Trial P: Duration
  • Oncology Trial Q
  • Figure 2.30: Oncology Trial Q: Background and Budget
  • Figure 2.31: Oncology Trial Q: Staffing
  • Figure 2.32: Oncology Trial Q: Duration and Enrollment
  • Oncology Trial R
  • Figure 2.33: Oncology Trial R: Background and Budget
  • Figure 2.34: Oncology Trial R: Staffing and Enrollment
  • Figure 2.35: Oncology Trial R: Duration
  • Oncology Trial S
  • Figure 2.36: Oncology Trial S: Background and Budget
  • Figure 2.37: Oncology Trial S: Staffing
  • Figure 2.38: Oncology Trial S: Duration and Enrollment
  • Oncology Trial T
  • Figure 2.39: Oncology Trial T: Background and Budget
  • Figure 2.40: Oncology Trial T: Staffing
  • Figure 2.41: Oncology Trial T: Duration and Enrollment

Phase 3 - Oncology Trials

  • Figure 3.1: Phase 3 - Total Trial Costs, by Trial
  • Figure 3.2: Phase 3 - Percentage of Costs Outsourced, by Trial

Phase 3 - Cost-Drivers

  • Figure 3.3: Phase 3 - Average Planned/Actual Patient Enrollment
  • Figure 3.4: Phase 3 - Planned/Actual Patient Enrollment, by Trial
  • Figure 3.5: Patient Enrollment Drives Phase 3 Trial Costs
  • Figure 3.6: Phase 3 - Cost Per Patient, by Trial
  • Figure 3.7: Phase 3 - Actual Duration, by Trial
  • Figure 3.8: Trial Duration and Phase 3 Trial Costs
  • Figure 3.9: Phase 3 - Cost Per Patient Per Month, by Trial

Phase 3 - Staffing

  • Figure 3.10: Average Phase 3 - Staffing, by Position
  • Figure 3.11: Patients Per CRA, by Trial
  • Figure 3.12: Phase 3 - Number of Sites, by Trial
  • Figure 3.13: Phase 3 - Number of Patients Per Site, by Trial
  • Figure 3.14: Phase 3 - Number of Sites Per CRA

Phase 3 - Oncology Trial Case Studies

  • Oncology Trial U
  • Figure 3.15: Oncology Trial U: Background and Budget
  • Figure 3.16: Oncology Trial U: Staffing and Enrollment
  • Figure 3.17: Oncology Trial U: Duration
  • Oncology Trial V
  • Figure 3.18: Oncology Trial V: Background and Budget
  • Figure 3.19: Oncology Trial V: Staffing and Enrollment
  • Figure 3.20: Oncology Trial V: Duration
  • Oncology Trial W
  • Figure 3.21: Oncology Trial W: Background and Budget
  • Figure 3.22: Oncology Trial W: Staffing and Enrollment
  • Figure 3.23: Oncology Trial W: Duration
  • Oncology Trial X
  • Figure 3.24: Oncology Trial X: Background and Budget
  • Figure 3.25: Oncology Trial X: Cost Metrics and Staffing
  • Figure 3.26: Oncology Trial X: Duration and Enrollment
  • Oncology Trial Y
  • Figure 3.27: Oncology Trial Y: Background and Budget
  • Figure 3.28: Oncology Trial Y: Staffing and Enrollment
  • Figure 3.29: Oncology Trial Y: Duration
  • Oncology Trial Z
  • Figure 3.30: Oncology Trial Z: Background and Budget
  • Figure 3.31: Oncology Trial Z: Staffing
  • Figure 3.32: Oncology Trial Z: Duration
  • Oncology Trial AA
  • Figure 3.33: Oncology Trial AA: Background and Budget
  • Figure 3.34: Oncology Trial AA: Staffing
  • Figure 3.35: Oncology Trial AA: Duration and Enrollment
  • Oncology Trial BB
  • Figure 3.36: Oncology Trial BB: Background and Budget
  • Figure 3.37: Oncology Trial BB: Cost Metrics
  • Figure 3.38: Oncology Trial BB: Duration and Enrollment
  • Oncology Trial CC
  • Figure 3.39: Oncology Trial CC: Background and Budget
  • Figure 3.40: Oncology Trial CC: Cost Metrics
  • Figure 3.41: Oncology Trial CC: Duration and Enrollment
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