Clinical Trial Recruitment Strategies in Oncology - Online Recruitment Methods and Use of IT - enabled Patient Management Systems will Reduce Recruitment Time and Cost

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Clinical Trial Recruitment Strategies in Oncology - Online
Recruitment Methods and Use of IT - enabled Patient Management
Systems will Reduce Recruitment Time and Cost
Published on May 2011

Report Summary

Clinical Trial Recruitment Strategies in Oncology - Online Recruitment Methods and Use of IT - enabled Patient Management
Systems will Reduce Recruitment Time and Cost

Summary

GBI Research has released its research, 'Clinical Trial Recruitment Strategies in Oncology - Online Recruitment Methods and Use of
IT - enabled Patient Management Systems will Reduce Recruitment Time and Cost', which provides insights into recruitment
strategies, challenges and solutions for on-time recruitment in oncology trials. The report also examines case studies to illustrate
enhanced recruitment in a shorter time. The A provides an in-depth analysis of the trials conducted by major pharmaceutical
companies for the top five oncology therapeutic indications, which are breast cancer, colorectal cancer, prostate cancer, lung cancer
and brain cancer.

GBI Research analyzed the critical factors that are responsible for the increase in timelines of the completion of clinical trials, the
increase in costs to conduct a clinical trial, and the delay in time to market. Adaptive clinical trials are aimed at striking a balance
between the needed dose response information and the increased cost associated with it. The simulation of clinical trials allows
pharmaceutical companies to compare and contrast the operating characteristics of the design options. Modeling, forecasting and
tracking the clinical trial enrollment gives an opportunity for the team to identify the problems before they happen. This results in
lowering the clinical trial cost and speeds up the time to regulatory submission. Companies wanting to reduce potential discrepancies
in the process and save costs are utilizing these solutions.

Oncology clinical trials are complex and involve a more diverse approach than trials in many other therapeutic areas. The most
challenging obstacle, especially in the US, is patient recruitment, where oncology trials have notoriously low participation rates among
adult patients. While more than 1.2 million Americans were newly diagnosed with cancer in 2010, participation in oncology trials
remains very low. According to the American Society of Clinical Oncology (ASCO), only 3% of US adults with cancer participated in
clinical trials. Lack of participation can cause an oncology trial to recruit slowly, often lengthening the trial's timeline by months or even
years.

Scope

The Scope of this report includes -
- Status of oncology trials share by geography, therapeutic area and major pharmaceutical companies.
- Cost of patient recruitment in oncology as a share of clinical trial.
- Site selection in oncology trials in multiple site trials, based on infrastructure, incidence, and study staff availability.
- Key drivers and restraints that have had a significant impact on the patient recruitment.
- Outsourcing patient recruitment to Clinical Research Organizations (CROs) to reduce the recruitment time.
- Use of IT-enabled patient recruitment systems making use of Electronic Health Records of patients, which reduces recruitment cost
and time and provides better patient availability.

Clinical Trial Recruitment Strategies in Oncology - Online Recruitment Methods and Use of IT - enabled Patient Management Systems will Reduce Recruitment Time and Co Page 1/7
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Reasons to buy

The report will enhance your decision making capability. It will allow you to -
- Build effective strategies for recruitment of patients in trials by reducing the drug's time to market.
- Exploit strategies for retention of patients by identifying the barriers and challenges involved.
- Develop key strategic initiatives by studying the key strategies of top competitors.
- Develop a better study design for better patient recruitment.
- Build a protocol involving less budget and more patients in less time.

Table of Content

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Clinical Trial Recruitment Strategies in Oncology: Introduction 9
2.1 GBI Research Report Guidance 9
3 Clinical Trials Overview 10
3.1 Clinical Trials in Oncology 10
3.1.1 Overview 10
3.2 Clinical Trials Share by Therapeutic Area 11
3.3 Clinical Trials by Major Pharmaceutical and Biotechnology Companies 18
3.4 Cost of Patient Recruitment as a Share of Total Clinical Trial Cost 19
4 Patient Recruitment Process for Clinical Trials 21
4.1 Effect of Clinical Trial Study Design on Patient Recruitment 21
4.1.1 Types of Study Designs 23
4.1.2 Challenges in Recruitment Related to Oncology Study Design 23
4.2 Evolution of Oncology Clinical Trials: Cytotoxic to Target Specific Trials 34
4.3 Inclusion/Exclusion Criteria 35
4.3.1 Challenges in Oncology Trials Due to the Stringent Inclusion/Exclusion Criteria 36
4.3.2 Challenges in Clinical Research: Volunteer Perspective 38
4.4 Importance of Timelines in Oncology Clinical Trials 39
4.4.1 Start Time and End Time Planning as a Major Milestone 39
4.4.2 Patient Recruitment Timeline Poses a Major Challenge in Lengthy Oncology Trials 39
4.5 Expenses Incurred in Oncology Trials and the Associated Costs Involved 40
4.5.1 Costs Involved in Treatment through Clinical Trials and Payments Made 40
4.5.2 Challenges Related to Budget Planning in Oncology Trials 40
4.6 Investigation Site Selection Along With Country Selection 43
4.6.1 Country/Site Selection Criteria 43
4.6.2 Site Selection Challenges in Oncology Trials 44
4.7 Determination of the Number of Clinical Trial Sites per Country in Multiple-Site Clinical Trials 50
4.7.1 Patient Recruitment Strategies in Multiple Site Trials 50
4.7.2 Coordination across Multi-Site Recruitments 51
4.7.3 Need for Multi-Site Recruitment 52
4.8 Patient Hiring Process in Oncology Trials 57
4.8.1 Patient Hiring Methods 57



5 Online Recruitment: Electronic Data Capture in Clinical Trials 61
5.1 Overview 61
5.2 Electronic Data Capture (EDC) 62
5.2.1 Cost Saving Scenario in EDC 63
5.2.2 Cost Saving Scenario for Phase I and Phase II Trial 65
5.2.3 Software as a Service (SaaS) based Electronic Data Capture (EDC) 66
5.2.4 Case Studies of Cost Saving by Adoption of EDC 67
5.3 Electronic Patient Report Outcome System (ePRO) 68
5.3.1 Cost Saving Scenario with eDiaries 70
5.4 Interactive Voice Response Systems (IVRS) 71
5.4.1 Case Studies of Supply Chain Management Systems 72
5.5 Clinical Data Management Systems (CDMS) 73
5.6 Clinical Trial Supply Chain Management System 74
5.7 Patient Retention Process in Clinical Trials 75
5.7.1 Challenges in Oncology Patient Recruitment 75
5.8 Partner Hiring ' CRO's Partner Selection Criteria in Outsourcing Patient Recruitment 79
6 Profiles of Major CROs in Patient Recruitment 80
6.1 Major Global CROs 80
6.1.1 Paragon Bio Medical 80
6.1.2 Exodon, LLC 82
6.1.3 TKL Research, Inc. 83
6.1.4 PPD 84
6.1.5 MediciGlobal 85
6.2 Major CROs in the US 86
6.2.1 D. Anderson & Co 86
6.2.2 Clinlogix 87
6.3 Major CROs in Asia-Pacific 88
6.3.1 Quintiles Transnational Corp 88
7 Appendix 90
7.1 Market Definitions 90
7.2 Abbreviations 90
7.3 Research Methodology 91
7.3.1 Coverage 91
7.3.2 Primary Research 92
7.3.3 Expert Panel Validation 92
7.4 Contact Us 92
7.5 Disclaimer 93
7.6 Sources 93

1.1 List of Tables
Table 1: Clinical Trial Recruitment Strategies in Oncology, Global, Ongoing Oncology Trials by Indication and Phases, 2005-2010 10
Table 2: Clinical Trial Recruitment Strategies in Oncology, Global, Ongoing Trials by Therapeutic Area, 2005-2010 11
Table 3: Clinical Trial Recruitment Strategies in Oncology, Asia, Ongoing Trials by Therapeutic Area, 2005-2010 12
Table 4: Clinical Trial Recruitment Strategies in Oncology, Europe, Ongoing Trials by Therapeutic Area, 2005-2010 13
Table 5: Clinical Trial Recruitment Strategies in Oncology, Middle East, Ongoing Trials by Therapeutic Area, 2005-2010 14
Table 6: Clinical Trial Recruitment Strategies in Oncology, South and Central America, Ongoing Trials by Therapeutic Area,
2005-2010 15
Table 7: Clinical Trial Recruitment Strategies in Oncology, North America, Ongoing Trials by Therapeutic Area, 2005-2010 16



Table 8: Clinical Trial Recruitment Strategies in Oncology, Rest of World, Ongoing Trials by Therapeutic Area, 2005-2010 17
Table 9: Clinical Trial Recruitment Strategies in Oncology, Global, Clinical Trials by Major Pharmaceutical Companies, 2005-2010 18
Table 10: Clinical Trial Recruitment Strategies in Oncology, Global, Time in Recruitment Per Patient, 2000-2010 20
Table 11: Clinical Trial Recruitment Strategies in Oncology, Global, Non-randomized Oncology Trial Study Design, 2005-2009 21
Table 12: Clinical Trial Recruitment Strategies in Oncology, Global, Randomized Oncology Trial Study Design, 2005-2009 22
Table 13: Clinical Trial Recruitment in Oncology, Cost of Cancer Care in the US, $bn, 1987 and 2005 27
Table 14: Clinical Trial Recruitment Strategies in Oncology, Global, Incidence and Mortality in Females, 2010 44
Table 15: Clinical Trial Recruitment Strategies in Oncology, Global, Incidence and Mortality in Males, 2010 45
Table 16: Clinical Trial Recruitment Strategies in Oncology, Global, Breast Cancer Cases and Deaths, 2010 46
Table 17: Clinical Trial Recruitment Strategies in Oncology, Global, Prostate Cancer Cases and Deaths, 2010 46
Table 18: Clinical Trial Recruitment Strategies in Oncology, Global, Colorectal Cancer Cases and Deaths, 2010 47
Table 19: Clinical Trial Recruitment Strategies in Oncology, Global, Lung Cancer Cases and Deaths, 2010 47
Table 20: Clinical Trial Recruitment Strategies in Oncology, Professionally Active Physicians by Geography, 1995-2009 48
Table 21: Clinical Trial Recruitment Strategies in Oncology, Number of Hospital Beds by Geography, 1995-2008 48
Table 22: Clinical Trial Recruitment Strategies in Oncology, Practicing Nurses by Geography, 1995-2009 49
Table 23: Clinical Trial Recruitment Strategies in Oncology, Data Management Setup Cost in India, 2009 56
Table 24: Clinical Trial Recruitment Strategies in Oncology, Phase I-II Cost Saving Scenario by Adopting EDC, 2009 65
Table 25: Clinical Trial Recruitment Strategies in Oncology, Reasons for Non-compliance in Clinical Trials and Solutions 76

1.2 List of Figures
Figure 1: Clinical Trial Recruitment Strategies in Oncology, Global, Ongoing Oncology Trials by Indication and Phases, 2005-2010 10
Figure 2: Clinical Trial Recruitment Strategies in Oncology, Global, Ongoing Trials by Therapeutic Area, 2005-2010 11
Figure 3: Clinical Trial Recruitment Strategies in Oncology, Asia, Ongoing Trials by Therapeutic Area, 2005-2010 12
Figure 4: Clinical Trial Recruitment Strategies in Oncology, Europe, Ongoing Trials by Therapeutic Area, 2005-2010 13
Figure 5: Clinical Trial Recruitment Strategies in Oncology, Middle East, Ongoing Trials by Therapeutic Area, 2005-2010 14
Figure 6: Clinical Trial Recruitment Strategies in Oncology, South and Central America, Ongoing Trials by Therapeutic Area,
2005-2010 15
Figure 7: Clinical Trial Recruitment Strategies in Oncology, North America, Ongoing Trials by Therapeutic Area, 2005-2010 16
Figure 8: Clinical Trial Recruitment Strategies in Oncology, Rest of World, Ongoing Trials by Therapeutic Area, 2005-2010 17
Figure 9: Clinical Trial Recruitment Strategies in Oncology, Global, Clinical Trials by Major Pharmaceutical Companies, 2005-2010 18
Figure 10: Clinical Trial Recruitment Strategies in Oncology, Global, Net Increase in Recruitment Cost Due to Delay, 2005-2010 19
Figure 11: Clinical Trial Recruitment Strategies in Oncology, Global, Time in Recruitment Per Patient, 2000-2010 20
Figure 12: Clinical Trial Recruitment Strategies in Oncology, Global, Oncology Trial Study Design, 2005-2009 21
Figure 13: Clinical Trial Recruitment Strategies in Oncology, Case Study Recruitment Model 24
Figure 14: Clinical Trial Recruitment Strategies in Oncology, Cost of Cancer Care in the US, $bn, 1987 and 2005 27
Figure 15: Clinical Trial Recruitment Strategies in Oncology, Global, Expenditure (%), 2001 28
Figure 16: Clinical Trial Recruitment Strategies in Oncology, Global, Expenditure (%), 2005 28
Figure 17: Clinical Trial Recruitment Strategies in Oncology, Cost of Cancer Care, 2007 29
Figure 18: Clinical Trial Recruitment Strategies in Oncology, Cytotoxic to Target Specific Trials 34
Figure 19: Clinical Trial Recruitment Strategies in Oncology, Factors Impacting Clinical Data Management Outsourcing, 2009 53
Figure 20: Clinical Trial Recruitment Strategies in Oncology, End-to-End Services Offered by Large IT Vendors, 2009 54
Figure 21: Clinical Trial Recruitment Strategies in Oncology, Supply Chain in Clinical Trials, 2009 55
Figure 22: Clinical Trial Recruitment Strategies in Oncology, CTMS Application by Sponsor / CROs 58
Figure 23: Clinical Trial Recruitment Strategies in Oncology, Electronic Data Capture Process 62
Figure 24: Clinical Trial Recruitment Strategies in Oncology, Cost Saving Scenario in Electronic Data Capture, 2009 63
Figure 25: Clinical Trial Recruitment Strategies in Oncology, Data Quality Gap, 2009 64
Figure 26: Clinical Trial Recruitment Strategies in Oncology, SaaS based EDC System, 2009 66
Figure 27: Clinical Trial Recruitment Strategies in Oncology, EDC Cost Saving in Clinical Trials, by Therapy, 2009 67



Figure 28: Clinical Trial Recruitment Strategies in Oncology, Cost Saving Scenario of ePRO Solutions, 2009 69
Figure 29: Clinical Trial Recruitment Strategies in Oncology, Case Study of ePRO Solutions, 2009 70
Figure 30: Clinical Trial Recruitment Strategies in Oncology, Integration of IVR with Other Systems, 2009 71
Figure 31: Clinical Trial Recruitment Strategies in Oncology, Clinical Data Management Flow, 2009 73
Figure 32: Clinical Trial Recruitment Strategies in Oncology, Clinical Trial Supply Management System, 2009 74
Figure 33: Clinical Trial Recruitment Strategies in Oncology, Analysis of Adverse Events in 10 Recent Oncology Trials 78
Figure 34: Clinical Trial Recruitment Strategies in Oncology, Paragon Biomedical Overview 80
Figure 35: Clinical Trial Recruitment Strategies in Oncology, Exodon LLC, Overview 82
Figure 36: Clinical Trial Recruitment Strategies in Oncology, TKL Research, Overview 83
Figure 37: Clinical Trial Recruitment Strategies in Oncology, PPD, Overview 84
Figure 38: Clinical Trial Recruitment Strategies in Oncology, MediciGlobal, Overview 85
Figure 39: Clinical Trial Recruitment Strategies in Oncology, D Anderson & Company, Overview 86
Figure 40: Clinical Trial Recruitment Strategies in Oncology, Clinlogix, Overview 87
Figure 41: Clinical Trial Recruitment Strategies in Oncology, Quintiles Transnational Corp, Overview 88
Companies mentioned


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