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臨床試験の時間およびコストの削減:被験者募集・物流・データ・施設管理の最適化のためのアウトソーシングおよびIT

Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management

発行 GBI Research 商品コード 200298
出版日 ページ情報 英文 78 Pages
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臨床試験の時間およびコストの削減:被験者募集・物流・データ・施設管理の最適化のためのアウトソーシングおよびIT Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management
出版日: 2011年06月01日 ページ情報: 英文 78 Pages
概要

臨床試験は医薬品開発プロセスにおけるもっとも重要な工程のひとつです。臨床試験には、技術の実装、効果的なサプライチェーン管理、適切な施設選定、被験者募集、データベース管理など、実にさまざまな側面が関連しています。

当レポートでは、臨床試験の時間およびコストの削減戦略について調査分析し、臨床試験の工程、各工程における時間およびコスト削減のための各種技術、ITソリューションの影響力、CROへのアウトソーシングの効果、CDISC標準の順守による影響、各種ケーススタディなどをまとめ、概略以下の構成でお届けします。

第1章 目次

第2章 臨床試験の時間およびコストの削減:イントロダクション

第3章 臨床試験の時間およびコストの削減:臨床試験の工程

第4章 臨床試験の時間およびコスト削減を支援するバイオマーカーおよびサロゲートエンドポイント

第5章 施設選定・管理:コスト・時間効率の良い臨床試験の推進

  • 時間通りの施設始動:期日までの臨床試験完了のために必須
    • 施設始動プロセス
    • 施設始動の遅れを最小限にするための主要因子
    • 治験施設支援機関(SMO):タイムラインの短縮

第6章 効果的で効率的な時間差削減のサプライチェーン管理

  • 臨床試験における効率的なサプライチェーン管理の主要因子
    • プランニング
    • 製造
    • 流通
    • 可視性
  • 業務計画のe臨床試験ソリューション
    • 臨床試験供給管理システム(CTSM:Clinical Trial Supply Management System)
    • RFIDタグアーキテクチャ
    • RFID ITアーキテクチャ

第7章 臨床試験管理を支援する情報技術

  • イントロダクション
  • EDC:Electronic Data Capture
    • EDCのコスト削減シナリオ
    • SaaSベースのEDC
    • ケーススタディ
  • 音声自動応答装置(IVRS)
    • リアルタイム臨床試験データトラッキング
  • ePRO(Electronic Patient Reported Outcomes)
  • EHR(Electronic Health Record)
  • 臨床試験管理システム(CTMS)
  • 予測モデリングツールによるコスト削減
    • 予測モデリングツールのROI

第8章 Clinical Data Interchange Standards Consortium(CDISC)標準による臨床試験のコスト削減

  • CDISCの各種標準
    • 各種標準の導入

第9章 アウトソーシング:臨床試験の実行を再定義するCRO(CRO)

  • イントロダクション
  • CRO(医薬品開発業務受託機関)
    • 臨床開発アウトソーシング:コスト上昇や低い生産性を解消するソリューションと考えられている
    • 戦略的アウトソーシング:ベンダーおよびアウトソーシング企業のコアコンピテンシーの理解による価値の提供
  • CROへのアウトソーシングの主な理由
    • コスト削減の希望:開発業務アウトソーシングの主な理由
    • CRO:競争上の優位性を実現するため上市までの時間の削減
    • データ管理などのリソース・時間を要する機能のアウトソーシング:バイオ医薬品企業はコアコンピテンシーへの集中が可能に
    • リスク共有契約の発展:バイオ医薬品は開発業務のアウトソーシングを拡大しやすい環境に
    • CRO:技術の発展を把握し、規制を理解することで臨床開発の質の向上を支援
    • 中小規模のバイオ医薬品企業:CROリソースを活用できる
    • CROがアクセスを持つ新技術でメリットを受けるバイオ医薬品企業
  • 臨床試験のコスト:アウトソーシングによる大幅な削減
    • インドの臨床試験実行コスト
  • 開発業務アウトソーシング -サービスモデル
    • 開発業務アウトソーシングサービスモデル
    • CRO選定の基準
    • 前期医薬品開発のアウトソーシング
    • 臨床段階の医薬品開発のアウトソーシング
    • 後期開発のアウトソーシング

第10章 臨床試験の工程に関連する主要企業:プロファイル

第11章 付録

図表

目次
Product Code: GBIHC088MR

Summary

GBI Research, the leading business intelligence provider, has released its latest research, “Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management”. The report provides in-depth analysis of the major factors which lead to time and cost efficient clinical trials. The report analyzes the importance of implementation of IT to get error-free data related to patient recruitment, patient responses, site management and logistics.

Clinical trials are one of the most important parts of the drug development process. The various aspects involved in clinical trials such as implementation of technology, efficient supply chain management, proper site selection, patient recruitment, database management and others are important.

At present the rate of new drug approvals is declining with every passing year. Biopharmaceutical companies are under huge pressure to reduce the time required for drug development. It is equally important to cut costs of drug development so that adequate revenue generation can be maintained by pharmaceutical companies. Patent expiration of major drugs is leading to a reduction in the revenue generated by pharmaceutical companies. Biopharmaceutical companies therefore need to consider new approaches which will lead to time and cost reduction in clinical trials without affecting the quality of the trials.

GBI Research finds that it is very important for the pharmaceutical industry to launch new drugs in the market in order to maintain revenue generation. Large sums of money are invested by pharmaceutical companies for the development of drugs. Revenue generated by pharmaceutical companies is dependent upon the patent period of the drug, and many drugs are facing the challenge of patent expiry.

This report is built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis by GBI Research’s team of industry experts.

Scope

The scope of this report includes -

• Description of clinical trial phases.
• Analysis of the leading techniques which will lead to cost efficient conduction of clinical trials.
• Analyzes how the use of surrogate endpoints reduces the duration of clinical trials, leading to reduced study timelines.
• Analysis of the impact of IT solutions to reduce the cost of clinical trials.
• Description of the ways in which outsourcing helps in minimizing time and cost required for clinical trials.
• Analysis of efficient clinical trial site management so that completion of a trial is done on time.
• Detailed case studies to highlight the impact of IT and outsourcing on clinical trial cost reduction.

Reasons to buy

The report will enhance your decision making capability. It will allow you to -

• Develop strategy to implement IT for time and cost efficient patient recruitment, data and site management.
• Develop market knowledge about key companies to which outsourcing of clinical trials can be done. Key deals of CROs are discussed in detail.
• Develop strategies by identifying the key components which can lead to reduced study timelines.
• Ensure efficient clinical trial outcome by implementing CDISC standards.
• Develop effective business strategies related to clinical trials through the analytical insight gained from case studies.
• Ensure success of clinical trial management by analysis of adequate techniques.

Executive Summary

GBI Research, the leading business intelligence provider, has released its latest research, “Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management”. The report provides in-depth analysis of various strategies adopted for reducing the time and cost involved in clinical trials. The report analyzes the key factors which should be considered in efficient clinical trial processes. It gives a robust idea about how the application of technology can lead to time and cost efficient clinical trials.

Clinical trials are one of the most important parts of the drug development process. The various aspects involved in clinical trials such as implementation of technology, efficient supply chain management, proper site selection, patient recruitment, database management and others are important.

The Clinical Research Process - Clinical Development is one of the most time consuming stages so time efficient methods need to be incorporated

Clinical research is critical to the success of biopharmaceutical companies. Within it, the clinical trial is the most time consuming stage of drug development. Therefore, biopharmaceutical companies are focusing on ways to improve their efficiency of the clinical research process in order to maximize gains. This requires considerable investment from biopharmaceutical companies for the conduction of quality clinical trials.

Time and Cost Reduction in Clinical Trials, Clinical Research Process, 2010

Source: GBI Research

The above figure shows the step-by-step process for a drug to be developed along with the time-line to pass through all the phases of clinical research to reach the patient population. Clinical research is conducted in humans to verify if a new drug or therapy is safe and effective for treating a disease or condition. Clinical trials are conducted in different phases and on average it takes 12 to 14 years to discover and market one new drug. Pharmaceutical and biotechnology companies spend approximately $900m in bringing each new drug into the market.

Cost Saving Scenario in Electronic Data Capture (EDC) - Use of Electronic Method Leads to Reduction in Cost of Clinical Trial

Time and Cost Reduction in Clinical Trials, EDC System- Cost Saving Scenario, 2010

If EDC is utilized in a multi center clinical trial study of 40 sites with 1,000 patients and 100 CRF’s, then potentially around $1.12m in cash could be saved. This clearly signifies that the EDC system should be implemented in order to reduce the cost of clinical trial.

Site Management Organizations (SMOs) - Reduces Study Timelines and Leads to Timely Completion of Clinical Trials

It has been observed that the use of SMOs leads to an overall reduction in study timelines. One of the characteristic factors responsible for this reduction in study timelines is the effective patient recruitment by SMOs. There is an improvement in pre-study planning and feasibility because SMOs are committed to the proper functioning of the clinical trial site. There is efficient communication among the subjects, Principal Investigator (PI), and sponsors which leads to improvement in patient retention and faith of patients on the trial. The ethics committee effectively deals with the region- specific ethical issues associated with the clinical trial.

ePRO (Electronic Patient Reported Outcomes) Reduces the Cost of Clinical Trials and Improves Data Quality

Use of ePRO instead of paper helps in improving patient compliance and quality of data which is gathered. By the use of ePRO the increase in patient compliance can improve by 97%. The acceptance of ePRO data by Food and Drug Administration (FDA) and European Medicines Agency (EMA) has led to an increase in its use. The choice of data collection method depends upon many factors such as number of patients, number of responses required, trial end point, and indication which is being studied. The choice of data collection method should lead to cost and time reduction without any compromises on the quality of data which is collected.

The initial cost of setting up ePRO is higher than the paper based method of data collection but the overall return on investment is larger. ePRO leads to long term reduction in the cost of data collection which is the reason why the majority of pharmaceutical companies are now switching to ePRO from the paper based data collection method. Cost reduction in clinical trials and thus in the overall drug development by ePRO is because of the increased patient compliance resulting in improved quality of data collected. ePRO helps in efficient data management by reviewing and verifying data.

If process mapped, by using ePRO solutions, a company would be able to save the cost of data entry, site monitoring, site review and data collection

Companies Mentioned

  • Paragon Biomedical
  • Exodon
  • D. Anderson & Co
  • KIKA Medical
  • Omnicomm Systems
  • eResearch Technology
  • Prelude Dynamics
  • Clinipace
  • Phase Forward
  • Perceptive Informatics
  • DZS/ Clinplus
  • Quintiles
  • Covance
  • Pharmaceutical Product Development (PPD)
  • Charles River Laboratories
  • PAREXEL International

Table of Contents

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 8
2 Time and Cost Reduction in Clinical Trials- Introduction 9
2.1 GBI Research Report Guidance 9
3 Time and Cost Reduction in Clinical Trials- Clinical Trial Process 10
3.1 Introduction 10
3.1.1 The Clinical Research Process 10
3.1.2 Clinical Trial Process and Types of Clinical Trial Outcomes 13
4 Biomarkers and Surrogate End-points Help in Reducing Time and Cost of Clinical Trials 15
5 Site Selection and Management - Facilitates Cost and Time Efficient Clinical Trial 18
5.1 Timely Site Initiation is Mandatory for Completion of Clinical Trials on time 18
5.1.1 Site Initiation Process 18
5.1.2 Key Factors for Minimizing Site Initiation Delays 19
5.1.3 Site Management Organizations (SMOs) - Reduces Study Timeline 21
6 Effective and Efficient Supply Chain Management Reduces Time Lag 22
6.1 Key Factors for Efficient Supply Chain Management in Clinical Trials 22
6.1.1 Planning Issues 22
6.1.2 Manufacturing Issues 23
6.1.3 Distribution Issues 24
6.1.4 Visibility Issues 24
6.2 e-Clinical Trial Solutions in Operational Planning 24
6.2.1 Clinical Trial Supply Management System (CTSM) 24
6.2.2 Radio Frequency Identification (RFID) Tag Architectures 26
6.2.3 RFID IT Architecture 26
7 Information Technology Helps in Improving Clinical Trial Management 27
7.1 Introduction 27
7.2 Electronic Data Capture (EDC) 28
7.2.1 Cost Saving Scenario in EDC 31
7.2.2 Software as a Service (SaaS) based EDC 33
7.2.3 Case Studies 34
7.3 Interactive Voice Response System (IVRS) 35
7.3.1 The IVRS Provides the Real Time Clinical Trials Data Tracking for The Following 36
7.3.2 Case Study 37
7.4 ePRO (Electronic Patient Reported Outcomes) 39
7.5 EHR (Electronic Health Record) 41
7.6 Clinical Trial Management System (CTMS) 42
7.7 Cost Saving By Predictive Modeling Tool 44
7.7.1 ROI of Predictive Modeling Tools 44
8 Implementation of Clinical Data Interchange Standards Consortium (CDISC) Standards Reduces Cost of Clinical Trials 46
8.1 Various Standards in CDISC 46
8.1.1 Adoption of Various Standards 47
8.1.2 Cost Saving for a Single Study 48
8.1.3 Revenue Gained for a Single Product 49
9 Outsourcing- Contract Research Organizations (CROs) are Re-defining the Conduct of Clinical Trials 50
9.1 Introduction 50
9.2 Contract Research Organizations (CROs) 51
9.2.1 Clinical Research Outsourcing is seen as a Solution to Problems such as Rising Costs or Low Productivity 51
9.2.2 Strategic Outsourcing Delivers Greater Value by Understanding the Core Competencies of the Vendor and Outsourcing Companies 51
9.3 Key Reasons for Outsourcing to Contract Research Organizations 52
9.3.1 Desire to Reduce Costs is a Prime Reason for Contract Research Outsourcing 53
9.3.2 CROs are Engaged to Reduce Time to Market in order to Achieve Competitive Edge 53
9.3.3 Outsourcing Resource and Time Intensive Functions such as Data Management Allows Biopharmaceutical Companies to Focus on Core Competencies 54
9.3.4 Evolving Risk Sharing Agreements Attract Biopharmaceutical Companies to Increase Contract Research Outsourcing 54
9.3.5 CROs are Helping to Improve the Clinical Research Quality through Better Regulatory Understanding and Keeping Pace with Technological Advances 54
9.3.6 Small and Medium Biopharmaceutical Companies can Leverage on the Resources of CROs 55
9.3.7 Biopharmaceutical Companies Benefit from New Technologies that a CRO Has Access to 55
9.4 Cost of Clinical Trial is reduced by Outsourcing by a Significant Amount 56
9.4.1 Cost of Conducting Clinical Trials in India is Approximately 55% of the Cost of Conducting a Clinical Trial in the US 56
9.5 Contract Research Outsourcing - Service Models 57
9.5.1 Contract Research Outsourcing Service Model 57
9.5.2 Criteria for Selecting a CRO 60
9.5.3 Early Stage Drug Development Outsourcing 61
9.5.4 Clinical Stage Drug Development Outsourcing 63
9.5.5 Late Stage Development Outsourcing 65
10 Profile of Key Companies Dealing in Clinical Trial Processes 67
10.1 Paragon Biomedical 67
10.1.1 Overview 67
10.2 Exodon 67
10.2.1 Overview 67
10.3 D. Anderson & Co. 67
10.3.1 Overview 67
10.4 KIKA Medical 67
10.4.1 Overview 67
10.5 Omnicomm Systems 68
10.5.1 Overview 68
10.6 eResearch Technology 68
10.6.1 Overview 68
10.7 Prelude Dynamics 68
10.7.1 Overview 68
10.8 Clinipace 68
10.8.1 Overview 68
10.9 Phase Forward 69
10.9.1 Overview 69
10.9.2 Key M&A Deals and Alliances 69
10.10 Perceptive Informatics 69
10.10.1 Overview 69
10.10.2 Key M&A Deals and Alliances 69
10.11 DZS/ Clinplus 70
10.11.1 Overview 70
10.12 Quintiles 70
10.12.1 Overview 70
10.12.2 Key M&A Deals and Alliances 70
10.13 Covance 71
10.13.1 Overview 71
10.13.2 Key M&A Deals and Alliances 71
10.14 Pharmaceutical Product Development (PPD) 72
10.14.1 Overview 72
10.14.2 Key M&A Deals and Alliances 72
10.15 Charles River Laboratories 73
10.15.1 Overview 73
10.15.2 Key M&A Deals and Alliances 73
10.16 PAREXEL International 74
10.16.1 Overview 74
10.16.2 Key M&A Deals and Alliances 74
11 Appendix 75
11.1 Market Definitions 75
11.2 Abbreviations 75
11.3 Research Methodology 76
11.3.1 Coverage 76
11.3.2 Secondary Research 76
11.3.3 Primary Research 77
11.3.4 Expert Panel Validation 77
11.4 Contact Us 77
11.5 Disclaimer 77
11.6 Sources 78

List of Tables

Table 1: Time and Cost Reduction in Clinical Trials, Factors for Minimizing Time Delays in Site Initiation, 2010 19
Table 2: Time and Cost Reduction in Clinical Trials, Cost of Query Resolution- Comparison of Paper based and EDC based Query Resolution Cost, 2010 34
Table 3: Time and Cost Reduction in Clinical Trials, Cost of Monitoring- Comparison of Paper Based and EDC Based Trial Monitoring, 2010 34
Table 4: Time and Cost Reduction in Clinical Trials, Role of EHR in Clinical Trial Process, 2010 41
Table 5: Time and Cost Reduction in Clinical Trials, Cost Comparison, The US vs. India, ($’000), 2009 56
Table 6: Time and Cost Reduction in Clinical Trials, Outsourcing Models for Drug Development, 2010 57

List of Figures

Figure 1: Time and Cost Reduction in Clinical Trials, Clinical Research Process, 2010 10
Figure 2: Time and Cost Reduction in Clinical Trials, Clinical Trial Process, 2010 13
Figure 3: Time and Cost Reduction in Clinical Trials, Types of Clinical Trial Outcome, 2010 13
Figure 4: Time and Cost Reduction in Clinical Trials, Surrogate Endpoint - Not Causal Pathway of Disease Process, 2010 15
Figure 5: Time and Cost Reduction in Clinical Trials, Surrogate-Affected by Intervention, 2010 16
Figure 6: Time and Cost Reduction in Clinical Trials, Surrogate - Not in the Pathway of Intervention, 2010 16
Figure 7: Time and Cost Reduction in Clinical Trials, Mode of Action (MoA) of Intervention is Independent of Disease Process, 2010 17
Figure 8: Time and Cost Reduction in Clinical Trials, Site Initiation Process, 2010 18
Figure 9: Time and Cost Reduction in Clinical Trials, Key Factors Responsible for Study Timeline Reduction by SMOs, 2010 21
Figure 10: Time and Cost Reduction in Clinical Trials, Supply Chain in Clinical Trials, 2010 23
Figure 11: Time and Cost Reduction in Clinical Trials, Clinical Trial Supply Management System, 2010 25
Figure 12: Time and Cost Reduction in Clinical Trials, RFID Technologies in Clinical Trials, 2010 26
Figure 13: Time and Cost Reduction in Clinical Trials, Clinical Trial Data Management by IT, 2010 27
Figure 14: Time and Cost Reduction in Clinical Trials, Paper CRF Method of Data Capturing, 2010 29
Figure 15: Time and Cost Reduction in Clinical Trials, Electronic Data Capture through e-CRF, 2010 30
Figure 16: Time and Cost Reduction in Clinical Trials, EDC System- Cost Saving Scenario, 2010 31
Figure 17: Time and Cost Reduction in Clinical Trials, Data Quality Gap Between Electronic and Paper Based Data Capturing, 2010 32
Figure 18: Time and Cost Reduction in Clinical Trials, SaaS based EDC System, 2010 33
Figure 19: Time and Cost Reduction in Clinical Trials, Use of IVRS in Shipment Request Process for Inventory Management, 2010 35
Figure 20: Time and Cost Reduction in Clinical Trials, Cost Saved by Using IVRS - Reduction in Overages, 2010 37
Figure 21: Time and Cost Reduction in Clinical Trials, Cost of Over-Recruitment by 10% in Different Study Samples, 2010 38
Figure 22: Time and Cost Reduction in Clinical Trials, Cost Saving Scenario of ePRO Solutions, 2010 39
Figure 23: Time and Cost Reduction in Clinical Trials, Case Study of ePRO Solutions, 2010 40
Figure 24: Time and Cost Reduction in Clinical Trials, Support of EHR in Clinical Trials, 2010 41
Figure 25: Time and Cost Reduction in Clinical Trials, A Typical Clinical Trial Management System, 2010 43
Figure 26: Time and Cost Reduction in Clinical Trials, Cost Saving Scenario of a Predictive Modeling Solution, 2010 45
Figure 27: Time and Cost Reduction in Clinical Trials, Adoption % of CDISC Standards, 2004/2005 and 2007 47
Figure 28: Time and Cost Reduction in Clinical Trials, Cost Saving for a Single Study Using CDISC, 2010 48
Figure 29: Time and Cost Reduction in Clinical Trials, Revenue Gained for a Single Product Using CDISC, 2010 49
Figure 30: Time and Cost Reduction in Clinical Trials, Contract Research Outsourcing - Reasons for Outsourcing, 2010 52
Figure 31: Time and Cost Reduction in Clinical Trials, Contract Research Outsourcing- Fully Integrated Service Model, 2010 58
Figure 32: Time and Cost Reduction in Clinical Trials, Contract Research Outsourcing- Functional Service Model, 2010 59
Figure 33: Time and Cost Reduction in Clinical Trials, Strategic or Tactical Advantages in Early Stage Drug Development Outsourcing, 2010 61
Figure 34: Time and Cost Reduction in Clinical Trials, Strategic or Tactical Advantages of Outsourcing in Clinical Stage of the Drug Development Process, 2010 63
Figure 35: Time and Cost Reduction in Clinical Trials, Strategic or Tactical Advantages of Outsourcing in Late Stage of the Drug Development Process, 2010 65
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