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Wednesday, February 9, 2011
7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:25 Chairperson’s Opening Remarks
Diana Anderson, CEO and President, D. Anderson & Company
8:30 Community Engagement as a More Sustainable, Efficient and Cost-Effective Model for Recruitment
Nariman Nasser, Director, Participant Recruitment Service Clinical and Translational Science Institute University of California, San Francisco
Expansive numbers of sites in multiple countries has proven more cumbersome and less effective than expected as a broad solution to recruiting in today’s competitive market. Key partnerships between industry, academic research/medical institutions, practice-based networks and community leaders can lead to long-term benefits for both sponsors and participants. This session will explore how local communities view clinical research, how to increase general interest in clinical research participation given the current healthcare climate, and why this is the best approach for the future.
8:55 Sponsor and CRO Co-Presentation: Referral Programs Can Work for Clinical Research Studies
Tess Drahzal, United Biosource Corp.
Kate Boneck, Global Trial Optimization - Specialist, Merck & Co, Inc.
Marketing experts say that it takes the average person 8 times to see and/or hear a message before taking action. Then why do we think that one “Dear Colleague” letter is going to do the trick? Some research docs have perfected the referral network by concentrated on a few simple techniques. While this can be time consuming, it can lead to a steady stream of referrals at a much lower cost than a TV spot. Successful referral networks will utilize direct mailings, phone calls, e-mails, lunch ‘n learns and research information that may of interest to them. This session will give an overview of available tactics and discuss one case study that successfully used a referral network program.
9:20 Leveraging eRecruitment for Clinical Trial Enrollment
Scott Connor, Vice President, Marketing, Acurian, Inc.
With Web 2.0 and social media continuing to gain mindshare with consumers and marketers alike, the focus surrounding its effectiveness in recruiting patients for clinical trials has increased dramatically in recent months. Acurian provides insight into the pitfalls and possibilities of eRecruitment as a patient enrollment strategy, including performance metrics from recent trials.
9:45 Sponsored Presentation (Opportunity Available)
10:00 Networking Coffee Break in Exhibit Hall
10:40 Chairperson’s Remarks
David Fox, President & CEO, Praxis
10:45 Navigating the PRO Labyrinth: Selecting a Patient Recruitment Organization to Ensure Enrollment Optimization
Robert Loll, Vice President, Business Development & Strategic Planning, Praxis
Choosing the right Patient Recruitment Organization (PRO) to design and deploy an effective recruitment campaign that will enhance enrollment for your research sites.
11:00 Imagine Unity: EMR Search and Network for Clinical Care and Research
Ze Jiang, Project Leader, Senior Strategist, iQuartic
Our group of Health IT engineers is leveraging Electronic Medical Record (EMR) infrastructures to facilitate clinical trial patient identification and accrual. Our economic model is intended to create synergy between clinical care and research, while optimizing the return to both parties from the transition to EMR systems. Our approach can theoretically cut clinical trial patient recruitment cost and time by more than 50%.
11:15 Case Report: Pilot Study Results Presented for PatientLocate TM—Multi-Site Electronic Patient Recruitment Technology
David Haddick, Co-Founder and CEO, KDH Systems, Inc.
Usefulness of a new technology for managing the process of candidate identification for clinical trials was evaluated using PatientLocate™ at point-of-care. PatientLocate™ is a proprietary system that matches patients’ medical conditions to trial criteria in real time, and provides CRA’s with real-time feedback on patient identification and enrollment at trial sites. Data will be presented on the relative accrual rates of the sites in a trial that employed the technology vs. the sites that did not.
11:30 Interactive Panel
Using Social Networks and Emerging Technologies to Accelerate Clinical Trial Recruitment
Moderator: Suzanne Collins, Director, Operations, Trifecta Multimedical
David Williams, Chief Marketing Officer, PatientsLikeMe
Gretchen Goller, Patient Recruitment and Compliance Strategist, Operations, sanofi-aventis
Bonnie Brescia, Founding Principal, BBK Worldwide
Additional Panelists to be Announced
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
12:00 pm Lunch on your Own
1:25 Chairperson’s Remarks
Jeffrey Zucker, Senior Director and Global Head, Patient Recruitment, Kendle
1:30 Exceeding Recruitment Milestones-A Physician Perspective
Bradley Vince, D.O., President and Medical Director, Vince and Associates Clinical Research
Recent industry trends incorporating traditional clinical pharmacology safety, tolerability and pharmacokinetics parameters in early patient studies will be evaluated from the “real-world” research physician’s perspective for feasibility and challenges. Specifically, recruitment, retention and medical management of special populations in Proof of Concept (POC) studies will be discussed and the competing needs of adequate dosing to demonstrate efficacy vs. safety in special populations will be evaluated.
1:55 Development of Effective Strategies for Recruitment of Minority Populations into Clinical Trials
Karen Brooks, Director, Clinical Projects, Clinical Operations, sanofi-aventis
This session will provide insightful information to understand the various demographics of the minority patient. Awareness of these behavioral aspects will assist in the development of strategies to recruit minority patients within today’s media network. In addition, for study trial completion, this discussion will provide focused techniques to retain patients under a transforming environment.
2:20 Patient Recruitment Begins with Site Selection
Jill Guary, Director, Global Patient Recruitment and Retention Strategy Group, PAREXEL International
Patient recruitment is about a thoughtful way of identifying effective investigators that can contribute patients to a study. It is about selecting and qualifying the right sites based on data-driven decisions. It is about being prepared to deliver and knowing your patient database. It is not a step to consider after sites have been selected.
2:45 Afternoon Refreshment Break in Exhibit Hall
(Shared Session with Clinical Trial Forecasting, Budgeting, and Project Management)
3:10 Chairperson’s Remarks
Dale Jackson, President, Virtual Clinical Solutions
3:15 Closing the Gap between Perception and Reality: A Model for Improved Study Planning, Forecasting and Start Up
Mary Jane Schoepfer, Associate Director, Program Study Manager, Oncology-Axitinib, Global Clinical Trial Management, Pfizer
Jonathan Curry, Associate Director, Analysis and Planning Lead, GCTM Business Operations, Pfizer
The operational aspects of a protocol are often far more complex and “mine laden” than clinical teams recognize. Acknowledging the potential stumbling blocks up-front may lead to better decision making which could lead to a faster start-up and recruitment. This model attempts to highlight the reality of executing the study by focusing on country selection and providing options for success.
3:40 Centralized Patient Recruitment as a Site Support Initiative: Leveraging Coordinator Buy-In for Integrated Strategies
Gregg Sweet, MBA, Vice President of Strategy and Development, ICTS Patient Recruitment (Integrated Clinical Trial Services, LLC)
Study coordinators are the gatekeepers of all patient recruitment plans. Their buy-in is essential for the success of any centralized recruitment effort. This session will explore proven tactics that assure the highest level of coordinator buy-in resulting in optimized cost, time and quality of the entire patient accrual strategy. Balancing the requirements of the protocol with the investigator sites’ threshold in processing referrals is key to successful integration of patient enrollment activities. Metrics from recent studies will be used to illustrate the cooperation between sponsor, sites and the centralized patient recruitment provider. Examples will be shown of study branded strategies that incorporate high levels of creativity with message retention and a good deal of fun for the recruitment teams and the prospective patients.
3:55 Utilizing Video Ad Network Aggregators as a Tactic in your Patient Recruitment Campaigns
Daniel D. Weddle, President & Founder, SiteAvail, Inc.
The application of Video Ad Networks (VAN) for placement of patient recruitment video is an innovative tactic within an overall campaign strategy. In this showcase, SiteAvail will present the “what, when, where, why, who, how” of working with VANs. Metrics associated with the first waves of using this VAN medium through its SiteCloud VAN Aggregator service will be provided. Challenges to adoption, target disease applications and future plans of the medium will also be addressed.
4:10 Clinical Trial Modeling and Simulation: Utilizing Real-Time Data from the Site Level Up through Regions and Countries
Manley Finch, Vice President, Clinical Research, Clinical Research Solutions, SleepMed, Inc.
Clinical development programs are continually shrinking “time-to-market” goals with earlier go/no-go decisions. Unsteady economic climate and the impact of tighter managed care reimbursement are the drivers. Cutting time to study start, last patient in (LPI), and database lock can save a Pharma millions in resources and preserve investor confidence. By strategically utilizing real time reporting of study metrics, competent program and project managers can reach these tighter utilization goals. Although commercial software can provide this needed technology, experienced clinical project managers, in collaboration with IT can easily craft tools providing the needed clinical trial forecasting and modeling.
4:35 Closing Remarks
4:45 End of Patient Recruitment in Clinical Trials