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Tuesday, March 9, 2010
7:45 am Chairperson’s Remarks
Charles Rathmann, Director, Recruitment Enhancement Core, Center for Applied Research Sciences, Washington University School of Medicine
Sponsored by
8:00 Breakfast Presentation
Can Electronic Healthcare Data be applied to Trial Design, Site Selection & Patient Recruitment?
Malcolm Bohm, President, Trialytics
Effective clinical development teams see the process of enrollment as starting at trial design, continuing through site selection and ending with the completion of recruitment. The emergence of effective tools that bring the evidence base of medical standard of care to clinical operations is empowering all clinical operations team to adopt this paradigm shift. This presentation is designed to provide all attendees an opportunity to understand how healthcare data can contribute to more cost effective and accelerated clinical development programs.
KEYNOTE PRESENTATION
8:40 Case Study: Recruiting Competitively - Internet Marketing or Traditional Media?
Ros Cheetham, Vice President, Neurosciences MDC, Medicine Development Leader, GlaxoSmithKline
Patient recruitment requires targeted and cost effective approaches to meet timelines and stay within budget. The value of internet marketing methods (Search Engine Optimization), traditional media (TV and radio) and low tech options such newspaper coupons, will be explored through two case studies. The response to these media and the costs will be evaluated. The balance between speed of patient recruitment and cost is critical for all clinical trials, especially in areas of clinical research where recruitment is highly competitive. With the advent of internet marketing methods it is important to understand what options are available and how they compare to “traditional” media methods. Through the use of two case studies, one of which used “traditional” media for patient recruitment and one of which used internet marketing, the audience will gain an understanding of the potential effectiveness, costs, and pitfalls of these approaches.
9:15 Comprehensive Patient Recruitment Programs: The Role of Community Organization and Social Marketing
Manley Finch, MS, MPH, Vice President, Clinical Research, SleepMed, Inc.
This presentation will review the need for the assessment of feasibility, design, and implementation of comprehensive programs at the program design level versus “band-aiding” as a rescue strategy. A review of the ROI for proper planning versus rescue mode will be provided. A review of the basics of recruitment programs will be offered with a latter concentration on discussion of using the principles of community organization and social marketing to drive trial awareness and recruitment enhancement. A case study will be offered as a cap-stone to summarize the information reviewed.
Rationale for comprehensive programs - Understanding of feasibility assessments
ROI for these programs versus band-aiding
Overall design of comprehensive program; menu items
Feasibility determination
Focus on the concepts of social behavioral modification, community organization, and social marketing to promote trial awareness and increase screening
9:45 Focus on Electronic Patient Recruiting
Sponsored by
David Haddick, Co-Founder and CEO, KDH Systems, Inc.
- Hospital-based, real-time automated patient screening for CT recruiting
- Subject identification and decision support enhances staff productivity
- Face-to-face meetings with candidates and physicians allows CT be to included in treatment decisions
- Collaborative, personal touch enhances enrollment while patient is on-site
- Benefits of clinical trials extended to complete population cross-section
10:00 Networking Coffee Break and Exhibit Viewing
10:40 Chairperson’s Remarks
Charles Rathmann, Director, Recruitment Enhancement Core, Center for Applied Research Sciences, Washington University School of Medicine
10:45 Regulatory Challenges and Expectations in Latin America and Asia Pacific to Effective Clinical Trial Development
Jerry Stewart, Associate Director, Global Regulatory Affairs, Asia & Latin America, Wyeth Research
Today, more than ever, clinical research is experiencing a geographical shift in country selection, and clinical trials are truly becoming more and more “global.” One of the industry’s goals is to execute simultaneous global development. That is, to use global data to develop a single dossier (e.g., Clinical Trial Application) that supports the next critical phase of development, enabling simultaneous submissions to and approvals from health authorities and ethics committees globally. There are a number of barriers that significantly restrict simultaneous development, ultimately delaying the availability of innovative drug therapy to emerging markets and limiting patient access to new and preventative treatment.
Presentation topics:
• Regulatory barriers in the AP and LA regions to simultaneous clinical development
• Industry’s expectations of a health authority’s regulatory framework
• Clinical elements to the ideal clinical trial infrastructure
11:15 Retention Begins with the First Screening Call
Mrs. Jeffree Itrich, Senior Communications Recruitment Specialist, ADCS Administration, University of California, San Diego
Too often clinical trials focus solely on recruitment, never giving any dedicated thought to retaining study participants once they sign on the dotted line. Retention is equally if not more important than recruitment because without a good retention strategy in place sites cannot maintain the participants they worked so hard to attract. My presentation will focus on retention techniques that have worked well for the over ADCS study sites over the last 18 years.
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
Manley Finch, Head of Neuroscience Clinical Trials, Clinical Operations, TEVA Neuroscience
Sponsored by
1:30 When Senior Management Says “Prove It!”...Can You Articulate Patient Recruitment ROI?
Richard Malcolm, Ph.D., Chief Executive Officer, Acurian
The session helps trial managers, patient recruitment specialists, and outsourcing personnel evaluate and budget patient recruitment fees, and illustrates how this can be a very cost effective spend (investment) through offsetting savings in personnel and trial costs, and can enable large financial returns through speeding time to market.
2:00 PARTNERS Initiative: sanofi-aventis’ approach to Enhancing Patient Recruitment
Richard Robinson, Assistant Director, Internal Medicine, Metabolism and Diabetes, US-CRU, sanofi-aventis
The PARTNERS initative is the sanofi-aventis “site management” program designed to improve site relationships and recruitment performance. This program began in 2006 with the goal of becoming “sponsor of choice” but over the years has morphed into a much more broad approach to site relationships. The program is designed around a customer focused approach and building of long term partnerships.
2:30 Sponsorship Available. Contact Arnie Wolfson: 781.972.5431, awolfson@healthtech.com
2:45 Networking Refreshment Break and Exhibit Viewing
3:30 An Update on Innovative Recruitment at Washington University: A Site Perspective
Charles Rathmann, Director, Recruitment Enhancement Core, Center for Applied Research Sciences, Washington University School of Medicine
The presentation will be addressing the unique, proactive, marketing based approach to recruitment at an Academic Medical Center. The discussion will focus on implemented planning and results, as well as challenges and opportunities associated with both. Case studies of successful recruitment for specific clinical trials and the strategies executed will also be shared.
4:00 Co-Presentation: Lessons Learned in Planning and Managing Adaptive Trials
Brendan O’Neill, Associate Director, Global Trial Optimization, Merck & Co., Inc.
Kelly White, Patient Recruitment Specialist, Merck & Co., Inc.
4:30 One Size Doesn’t Fit All: Site Level Case Studies from $0 to Centralized National Campaigns
Mark Metzner, Director, Marketing & Recruiting Department, Community Research
Patient recruitment is always challenging. Pharma and CROs are constantly looking at delivery models, historical data and PROs to try and forecast or deliver patient populations. This is an end-user perspective from the site level on what works and what may not be as effective as it appears on paper. Learn how you’re helping and perhaps harming your study by the choices you make. As an active General Medical, CNS and Oral Care site with a prototypical marketing and recruiting department, we have amassed a wealth of metrics. Far from an indictment of any one choice, this presentation focuses on the strengths and weaknesses of study media funding from the end-user or site level. This unique perspective offers all connected with the industry a chance to see what really happens when they make one choice compared to another.
5:00 Close of Patient Recruitment Conference
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