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 Powered By Docstoc
					            Clinical Trial Recruitment Strategies in Oncology -
           Online Recruitment Methods and Use of IT - enabled
                Patient Management Systems will Reduce
                         Recruitment Time and Cost
 Reference Code: GBIHC066MR                                                                                                     Publication Date: May 2011

                                    Increasing Focus of Major Pharmaceutical Companies on Oncology Markets
     AstraZeneca is conducting      Major pharmaceutical companies conduct clinical trials in many therapeutic areas, such as
     maximum number of trials       cardiovascular diseases, infectious diseases, oncology, metabolic disorders and central nervous
     in oncology for the period     system disorders.
     2005-2010
                                    GBI Research’s analysis finds that oncology is responsible for the most trials across the globe. The
                                    major pharmaceutical companies conducted more clinical trials in oncology than in other therapy
                                    areas during the period between 2005 and 2010.
                                    The figure below shows the number of trials by major pharmaceutical companies such as
                                    AstraZeneca, Bristol-Myers Squibb, Roche, Merck and Sanofi Aventis, and clearly demonstrates
                                    the prevalence of oncology trials.

                                     Clinical Trial Recruitment Strategies in Oncology, Global, Clinical Trials by Major
                                     Pharmaceutical Companies, 2005-2010

                                                           800



                                                           700



                                                           600



                                                           500
                                        Number of Trials




                                                           400



                                                           300



                                                           200



                                                           100



                                                            0
                                                                 AstraZeneca                    Bristol-Myers Squibb                Hoffmann-La Roche

                                                                 Cardiovascular   Central Nervous System   Infectious Disease   Oncology   Respiratory

                                     Source: GBI Research, www.clinicaltrials.gov , Company Websites

                                    Pharmaceutical companies are doing extensive research in oncology trials compared to other
                                    therapeutic areas. The higher incidence rates in cancer and increase in severity are the major
                                    drivers.
                                    GBI Research’s analysis estimated that the cost of one trial is approximately $2.28m. As the
                                    average time of an oncology trial is 4.5 years, the average cost of a trial is $0.5m per year.




Clinical Trial Recruitment Strategies in Oncology - Online                                                                 GBIHC066MR/Published MAY 2011
Recruitment Methods and Use of IT - enabled Patient
Management Systems will Reduce Recruitment Time and Cost                                                                                                 Page 1
                                                                                   © GBI Research. This is a licensed product and is not to be photocopied
                                    Outsourcing Clinical Trial Patient Recruitment Will Help Companies to Save Cost and Time
                                    Outsourcing of clinical trials to clinical research organizations (CROs) is becoming a major trend for
                                    pharmaceutical companies to reduce the time and cost of a trial. Outsourcing can be done for the
                                    whole trial or for part of a trial, which can be the start-up Phase, the ongoing part of the trial, or the
                                    data management part of the trial.
                                    Outsourcing a part of the trial helps with time management and relieves the sponsor to allow them
                                    to plan better for the other important parts of the trial, which then permits those to be managed in a
                                    better way.
                                    There are many CROs who work actively for patient recruitment. They manage their own online
                                    database of investigators, as well as the hospitals, clinics and private physicians and professionally
                                    active physicians. They have an idea about the type of patients to be obtained and about the kind
                                    and number of patients the site can provide for. Examples of CROs are D. Anderson and
                                    Company, Max Neeman, Clinlogix, PPD, and Quintiles.

                                     Clinical Trial Recruitment Strategies in Oncology, Outsourcing Strategy, 2005-2010


                                                                                            Impact on Outsourcing
                                                             Factors                              Decision


                                                                                                                              High
        Fig 2                                      Desire to Reduce Cost



                                                   Access to Special Expertise



                                                   Resource Constraints



                                                   Access to New Technologies



                                                   Focus on Core Competencies                                                 Low




                                     Source: GBI Research



                                    Increasing Use of IT-Enabled Patient Recruitment Platforms Will Help in Better Recruitment
                                    Management
                                    GBI Research finds that pharmaceutical companies are increasingly adopting e-clinical trial
                                    solutions in the drug development phase. The economic downturn, increased competition, patent
                                    expiry and the drying up of pipelines are pressurizing the biopharmaceutical industry to adopt e-
                                    clinical trial solutions and services that could optimize the drug development process and cut down
                                    costs.
                                    Online recruitment could be made better by the use of electronic medical records. The electronic
                                    repositories of the patients’ database could be of great help at the time of recruitment.
                                    A new study held at the University of Cincinnati (UC) shows that by using electronic medical
                                    records as a tool for patient recruitment, the number of volunteers participating in the trial can be
                                    increased, along with the increase in referrals from physicians from the referral community.




Clinical Trial Recruitment Strategies in Oncology - Online                                                   GBIHC066MR/Published MAY 2011
Recruitment Methods and Use of IT - enabled Patient
Management Systems will Reduce Recruitment Time and Cost                                                                                  Page 2
                                                                          © GBI Research. This is a licensed product and is not to be photocopied
                                    The success of a clinical trial totally depends on the recruitment of eligible candidates within the
                                    timelines. In the field of oncology, only 2% of the patients participate even though the researchers
                                    spend a lot of time in planning for the timely recruitment.
                                    The electronic health record (EHR) is an electronic health document of patients including the
                                    information related to patients’ demographics, progress notes, and medications, vital signs, past
                                    medical history, lab data and radiology reports. It has an inherent ability to bring together data from
                                    multiple practice sites under one electronic system, which enables quick development of a huge
                                    resource of patients’ records. An example of this is Holston Medical Group’s (HMG) EHR database,
                                    which with 200,000 patient records is an invaluable resource in prospectively assessing the actual
                                    number of patients that may meet trial protocols. These kinds of health records allow coverage of a
                                    wide range of patients from a large geographic area for a trial.
                                    There are many reasons for lower rates of participation in cancer trials. The physician who enrolls
                                    the patients for trials and the patients who agree to be part of the trial both have a barrier for
                                    participation in the trial. Overcoming these obstacles by a proper recruitment plan is the only way to
                                    bring an effective therapeutic to the market.




Clinical Trial Recruitment Strategies in Oncology - Online                                                 GBIHC066MR/Published MAY 2011
Recruitment Methods and Use of IT - enabled Patient
Management Systems will Reduce Recruitment Time and Cost                                                                                Page 3
                                                                        © GBI Research. This is a licensed product and is not to be photocopied
                                    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


Clinical Trial Recruitment Strategies in Oncology - Online                                                                             GBIHC066MR/Published MAY 2011
Recruitment Methods and Use of IT - enabled Patient
Management Systems will Reduce Recruitment Time and Cost                                                                                                                      Page 4
                                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                      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




Clinical Trial Recruitment Strategies in Oncology - Online                                                                           GBIHC066MR/Published MAY 2011
Recruitment Methods and Use of IT - enabled Patient
Management Systems will Reduce Recruitment Time and Cost                                                                                                                   Page 5
                                                                                      © GBI Research. This is a licensed product and is not to be photocopied
                                    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




Clinical Trial Recruitment Strategies in Oncology - Online                                                                           GBIHC066MR/Published MAY 2011
Recruitment Methods and Use of IT - enabled Patient
Management Systems will Reduce Recruitment Time and Cost                                                                                                                    Page 6
                                                                                    © GBI Research. This is a licensed product and is not to be photocopied
                                    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 Strat
				
DOCUMENT INFO
Description: 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
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