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CHI’s Third Annual Patient Recruitment in Clinical Trials: Successfully Planning and Managing Recruitment and Retention will be held March 8-9, 2010 at the Crowne Plaza Philadelphia Downtown in Philadelphia, PA. This year this gathering will be co-located with the Summit for Clinical Ops Executives (SCOPE), a four-day cluster of events taking place March 8-11, 2010. CHI’s Patient Recruitment will open with a pre-conference short course on ‘Designing and Implementing a Clinical Enrollment Plan’ and will be followed immediately by a short course on ‘Country and Site Feasibility and Selection for Global Clinical Trials’ and the Second Annual Drug Development Latin America conference.
Patient recruitment and retention are critical to drug development programs. Patient recruitment, if not adequately planned for, can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for your analysis and subsequent filings. In order to optimize both you have to have a plan. This conference is intended to cover the topics one should consider when drafting and strategically implementing a patient recruitment and retention plan for a clinical development program.
Monday, March 8, 2010
7:30 AM Morning Coffee & Conference and Short Course Registration
8:30 Organizer’s Welcome & Chairperson’s Opening Remarks
Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)
Richard Robinson, Assistant Director, Internal Medicine, Metabolism and Diabetes, US-CRU, sanofi-aventis
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8:40 Part 1: Clinical Recruitment Planning Strategies: When is the Right Time to Plan, Implement, and Spend?
 Manley Finch, MS, MPH, Vice President, Clinical Research, SleepMed, Inc.
It is well documented in the literature that eighty percent of clinical programs fail to meet their predetermined recruitment objectives. Either the study does not recruit the entire cohort projected or fails to do so on time. The need for comprehensive recruitment strategies to obtain enrollment objectives is acknowledged by most clinical research professionals including those at sponsors and academia. What is not intuitively understood is the right time to plan, implement, and spend to obtain the recruitment goals dictated by corporate executives or funding agencies. With research budgets shrinking and demands for decreased time to market increasing, knowing the answers to these questions are of critical importance to the success of any clinical development program or research project. This discussion will highlight and define the key indicators that will guide stakeholders and decision makers to strategically determine when, and when not to, begin planning, implementing and spending on comprehensive recruitment programs.
Sponsored by
.jpg?n=5484 "MMG Logo") 9:10 Part 2: Patient Retention and Compliance Strategies
Helen West, Vice President, Strategic Development, MMG
Patient retention and compliance strategies for global clinical trials will be presented by one of MMG’s senior strategists. This presentation will arm attendees with:
• Key drivers in designing retention programs
• Evolving trends in patient retention methodologies
• Best practices for the implementation of retention programs
• Adapting retention tactics for global implementation
Sponsored by
 9:40 Developing a Patient Recruitment Plan: Study Profiling, Strategy Development, Plan Implementation and Contingency Planning
Abbe Steel, Executive Director, United BioSource Corporation
This session will identify steps necessary to develop the nuts and bolts of a detailed patient recruitment plan. Each study is different, regardless of patient enrollment expectations, it is essential to define goals, plans, and strategies at the onset of every study. Key Drivers of a Patient recruitment plan include:
• Key Drivers of a Patient recruitment plan include: Critical Dates and Scope; Protocol Evaluation; Medical Condition and Subject Profile; Site Profile
• Critical elements of a recruitment plan will include: Site based support; Advertising; Public Relations and Outreach; Retention; Milestones; Triggers; Contingencies
10:15 End of Short Course, Networking Coffee Break
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10:50 Chairperson’s Opening Remarks
Richard Robinson, Assistant Director, Internal Medicine, Metabolism and Diabetes, US-CRU, sanofi-aventis
11:00 Opening Panel: The Study Volunteers - Hearing it from Their Perspective; That is What Really Counts!
Moderator: Christine Pierre, President & Chief Executive Officer, Clinical Research, RxTrials
Clinical Trial Volunteer Panelists:
Jay Scott – Father of Alex from Alex’s Lemonade Stand Foundation
Two other community study volunteer representatives
The study volunteer is the person we are all chasing after in this industry, however we seldom stop and ask their opinion with regard to much of what we do. This session will shed light on their opinions, beliefs, and actions which will in turn provide the audience with the gift of true knowledge in how to better recruit and retain study volunteers. During this interactive panel discussion with “real” study volunteers we will discuss with them and gain a deeper understanding of:
Their motivation to participate in a clinical study
What are the most effective methods to reach them
What they want and need to hear to make decisions
The role of the study staff and so much more!
11:30 Leveraging Social Media for Clinical Trial Recruitment Sponsored by
Bonnie Brescia, Founding Principal, BBK Worldwide
Today’s empowered patients seek information on their diagnosis and treatment options using the Internet, giving rise to a new breed of health consumer known as the ePatient. This session will discuss the ePatient in the context of clinical trial participation and will present strategies, including social networking, for partnering with this population to optimize enrollment. Online media is a growing reality and offers a huge opportunity for clinical trial recruitment, both for patients seeking options and for sponsors seeking trial participants. Social networking is the new buzzword, but it’s important to understand the nuances of use – particularly the differences in levels of control of information – to protect both patient privacy and scientific validity. Attendees will receive an assessment of the current online media vehicles; an analysis of the pros and cons of advertising, social networks, and online communities; and insight that they can apply to planning and implementing recruitment programs.
12:00 PM Luncheon Presentation (Sponsorship Available. Contact Arnie Wolfson: 781.972.5431, awolfson@healthtech.com) or Lunch on Your Own
1:25 Chairperson’s Remarks
Lance Nickens, President, The Patient Recruiting Agency™
1:30 Co-Presentation: Challenging Oncology Indication and the Just-In-Time (JIT) Approach: A Case Study of Collaboration between SMO and Trial Sponsor
Sona Gevorkian, Regional Study Manager, Site Management/Operations, Pfizer, Inc. (formerly Wyeth Research)
Fiona Patterson, Assistant Director II, Global Trial Leader, Pfizer, Inc. (formerly Wyeth Research)
Traditionally, clinical trial sponsors determine a limited number of investigative sites to open, based on presumptive modeling about sites’ patient populations, research foci, and ability to accrue over a set timeframe. In contrast, the Just-In-Time (JIT) model establishes study awareness and investigator engagement across a greater number of qualified sites, but initiates and opens sites only where and when candidate study subjects present; this extends the study reach and creates much broader patient access to trial participation while also mitigating risk of non-accrual at opened sites. JIT targets a more efficient recruitment model and better return on investment through this concentration of efforts, materials, and start-up capital at investigative sites where probability of immediate enrollment into a trial is high. This case study provides example of how the Just-In-Time model was applied to a challenging Phase III trial targeting a rare cancer indication, and explores how a large pharmaceutical company was able to successfully implement the Just-In-Time approach within its operational complexities.
Sponsored by
2:00 Reduce Risk – Proactively Plan Recruitment Strategies
Jaclyn Larsen, Marketing Strategy Manager, Praxis
Focusing efforts on proactively planning clinical trial recruitment increases the success of your trials. Risk reduction comes at every stage of proper planning. During this session we’ll give you the following tools to begin proactively planning your next trial:
• Meet enrollment faster by focusing budgets appropriately
• Spend less on trials by targeting creative messages
• Free study coordinator’s time to screen and enroll more patients
• Get more qualified patients inquiring about your study
Sponsored by
2:20 Utilizing the Internet for Global Site Selection and ROI Metrics for Local Recruitment Budgets
Lisa LaLuna, Senior Vice President of Corporate Development, ePharmaSolutions
Web based applications help to quickly and easily reach numerous users asynchronously, and provide a central forum to deliver metrics and manage information. This technology can be readily applied to optimize two main components of clinical trials: Site Selection and Management of Local Recruitment Budgets. Site Selection has been mired by an inability to aggregate information for sound business decision making, while millions of dollars are spent to support local recruitment efforts without ROI metrics. Attendees will be introduced to ClinicalCollaborator™, an online application that optimizes site selection and provides never before seen metrics for local recruitment budgets.
Sponsored by
2:40 Recruiting Metrics from Facebook Advertising
Lance Nickens, President, The Patient Recruiting Agency™
Sink your teeth into the metrics and costs of recruiting patients through Facebook advertising.
• Appetizers includes an assortment of real response metrics carved from indications all over the United States
• For the main course we will compare metrics from centralized campaigns including results from Facebook to Television, Radio and/or Print advertising
• For Desert you will learn about the savory costs from every indication on the menu
3:00 Networking Refreshment Break and Exhibit Viewing
3:45 Interactive Panel: Using Social Networks and Emerging Technologies to Accelerate Clinical Trial Recruitment
Ros Cheetham, Vice President, Neurosciences MDC, Medicine Development Leader, GlaxoSmithKline
Brian Loew, Chief Executive Officer, Inspire
David Williams, Chief Marketing Officer, PatientsLikeMe
Kirstin Woody-Scott, Program Manager, Vanderbilt Institute for Clinical and Translational Research, ResearchMatch.org
• Utilizing Web 2.0 and Health 2.0, social networking for clinical research and recruitment
• Leveraging database searches, pharmacy records, electronic medical records
• Ensuring regulatory compliance and patient privacy/HIPAA
4:15 Interactive Break-Out Discussion Groups
Concurrent break-out discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal yet informative format, that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
TABLE 1: Leveraging Social Media for Clinical Trial Recruitment
Bonnie Brescia, Founding Principal, BBK Worldwide
This roundtable will explore the characteristics of the proactive Internet health consumer – the e-patient – as well as the advantages and challenges of social media in relation to clinical trial recruitment and other new online advertising opportunities and methods for targeting the e-patient. Participants will discuss:
• Characteristics of the e-patient, today’s healthcare consumer.
• The elements of online social media that can be leveraged for clinical trial recruitment.
• Strategies for using Internet techniques as part of a patient recruitment plan.
TABLE 2: Why Is There So Much Interest in Risk Sharing or Performance Based Pricing in Patient Recruitment?
Richard Malcolm, Ph.D., Chief Executive Officer, Acurian
Gretchen E. Goller, MSW, Patient Recruitment/Compliance Strategist-Operations, sanofi-aventis US, Inc.
• What is performance-based pricing? What is risk sharing? How do they differ?
• What are the benefits of performance-based pricing?
• What should you look for in a contract that includes performance-based pricing? What options are available for performance-based pricing projects?
• Can you do risk sharing or performance based pricing without accurate metrics?
• Do any patient recruitment companies do risk sharing or performance based pricing? Why or why not?
TABLE 3: Recruitment Challenges and Unique Opportunities for Global Studies
Sona Gevorkian, Regional Study Manager, Site Management/Operations, Pfizer, Inc. (formerly Wyeth Research)
Fiona Patterson, Assistant Director II, Global Trial Leader, Pfizer, Inc. (formerly Wyeth Research)
This round table will explore the challenges and unique recruitment opportunities in global trials.
Discussion points:
• What type of infrastructure needs to be in place?
• What are some of the major causes of delays?
• What are the benefits to overall recruitment to conduct trials globally?
TABLE 4: Development of Effective Strategies for Recruitment of Minority Populations into Clinical Trials
Jeffree Itrich, Senior Clinical Trials Communications Specialist, Alzheimer's Disease Cooperative Study, University of California, San Diego
Karen Brooks, MS, CCRA, Associate Director, Therapeutic Operation, US-CRU, sanofi-aventis
• What minority population are you trying to recruit? Be realistic about what minorities live in your community with the disease you are studying.
• What should be in a plan for outreach into the minority communities? For example, visit community centers, clinics in minority communities, churches, anywhere that minorities congregate. Build trust with community leaders and minority focus groups that can help recruit into studies of interest to them.
• Does your site have an experienced minority recruitment coordinator with whom study subjects can relate?
TABLE 5: Can we Improve Site and Patient Recruitment Forecasting?
Rosalind Cheetham, Vice President, Neurosciences MDC, Medicine Development Leader, GlaxoSmithKline
Harry Barnett, Managing Partner, Clinical Assistance Programs (CAP)
• Why do sites always tend to over forecast how many eligible subjects they can recruit?
• What tools could we use to gain improved recruitment forecasts?
• How can we identify who will be the high quality, high enrolling sites?
TABLE 6: Recruitment Depends on Appropriate Site Reimbursement. Pay Now or Pay More Later.
Manley Finch, MS, MPH, Vice President, Clinical Research, SleepMed, Inc.
• The importance of appropriately paying clinical research centers for services rendered.
• Incentivization: When is it appropriate? In what form should it take? Regulatory considerations: CFR/GCP/ICH and PharmaCode
• Site level versus central funding for recruitment programs.
TABLE 7: Recruitment Materials and Messaging: Targeting Your Message and Media to the Appropriate Audience
Jaclyn Larsen, Marketing Strategy Manager, Praxis
• How do you determine the design and messaging of your materials?
• How can creative messaging be tailored to the patient and/or caregiver?
• What recruitment materials do you and your sites find most useful and effective in our current state of business?
• What is your process for creating effective media strategies?: What tactics to use; Where and when to place; Effective combinations
• What is the single biggest change you have seen that currently affects recruitment advertising effectiveness?
• What factors are in play when determining recruitment advertising budgets?
5:30 Closing Comments and Welcome to Reception
5:45-6:45 Networking Cocktail Reception and Exhibit Viewing
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