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Wednesday, February 6
11:30 am Conference Registration
Shared Luncheon Co-Presentation between Patient Recruitment and Retention and Global Site Selection
12:05 pm Bridging Luncheon Co-Presentation: The New Relationship with Patient Recruitment
Steve Swanson, President & COO, Imperial - Biography
Melynda Geurts, Vice President, Operations, DAC Patient Recruitment Services - Biography
New regulations, new pressures, new budgets, and new global expectations have made a significant impact on clinical trials in recent years. These changes require new skill sets and competencies that traditional patient recruitment models are not set to meet. Join us to learn key vendor evaluations including efficiency analysis, global capabilities, and vertical integration. Leave with an understanding of the new relationship with patient recruitment firms you and your team should expect.
1:25 Chairperson's Remarks
Bonnie A. Brescia, Founding Principal, BBK Worldwide - Biography
1:30 Featured Presentation: Implementing a Patient Recruitment and Retention Plan: Pearls of Wisdom
Gwen Welty, Global Clinical Site Developer, Global Clinical Site Development, Alcon Laboratories, Inc. - Biography
There are three main phases to consider when implementing a patient recruitment and retention plan. First is strategy: Why implement a recruitment and retention plan? What do you hope to accomplish from the program? The second phase is the challenges phase which incorporate the struggles and growing pains faced upon implementation of a formal program. Lastly is the outcomes phase which provide the desired data and results of implementation.
1:55 Patient Recruitment and Retention in a Private Hospital in Europe
Boris Nikolov, M.D., Research Manager, Clinical Research Department, Akta Medika Hospital - Biography
Implementing a protocol for patient recruitment in a research center at a private hospital in Bulgaria had lead to successful recruitment of large number of patients. Organization of free clinics upon award of a new study had helped define and enroll potential subjects in many studies. Successful follow up of these patients with additional medical services for free had boosted their retention. This presentation will share a working model that can be implemented globally, protocols that can be taken into practice in different sites and new protocols.
2:15 Scoping the Role of the In-House Patient Recruitment Specialist
Claire Reyneke, In-House Patient Recruitment Specialist, Centre for Clinical Research and effective practice (CCRep), Middlemore Hospital - Biography
The Centre for Clinical Research and effective practice (CCRep) is a dedicated clinical research facility, at Middlemore Hospital in South Auckland, New Zealand, with a broad suite of capability and is a single coordination point to manage all types of clinical trials. CCRep has a full suite of resources to achieve excellent trial results. CCRep has invested professional management time, expertise and money into the concept of embracing the “in-house Patient Recruitment Specialist” model at their clinical trial site in Auckland, New Zealand. Following conference attendance abroad, associated networking, research, human resources consultation and learning from past experiences, a local specialist recruitment agency was hired to source the ideal candidate for this newly created role. The chosen candidate, Claire Reyneke (who has been in the role of Patient Recruitment Specialist at CCRep since 1 February 2012), will present a first-hand account of how and why this role is working well at their clinical trial site.
2:35 Utilizing a Home Health Nurse Network in Clinical Trials
Mary James, Senior Manager, Patient and Physician Services, United BioSource Corporation (UBC) - Biography
As a method of reducing site burden and overall clinical development costs, pharmaceutical manufacturers have implemented innovative approaches to patient care and data collection. One approach has been utilizing home health nurses to perform activities that patients cannot perform themselves, but do not necessitate a site visit, such as administering investigational drugs, performing physical exams, collecting study data or performing specimen collection. This session will review strategies for utilizing home health nurses in clinical trials to increase patient retention and decrease costs.
3:00 Refreshment Break in the Exhibit Hall
3:40 The Most Cost Efficient Way to Enroll Patients – Patient Recruitment Services, Add Sites, or Add Time
Richard Malcolm, Ph.D., CEO, Acurian, Inc. - Biography
Whether a trial sponsor is prospectively evaluating enrollment timelines and foresees an issue, or is caught in a real-time enrollment shortfall, the options to address either challenge often come down to 3 choices: add sites, add time, or add patient recruitment services to close the patient enrollment gap. The answer differs on the situation and therapeutic area. This session examines multiple recruitment programs and compares specific cost drivers associated with patient enrollment services, sites, and time.
4:05 Patient Recruitment in Cancer Clinical Trials: Balancing Patient and Physician-Directed Approaches
Martin Lee, M.D., Executive Vice President, Clinical Trial Services, DAVA Oncology - Biography
Traditional patient recruitment tactics have focused on outreach to patients through the production of appropriate materials and advertising through a variety of media. Direct outreach to physicians has also been shown to be an effective strategy to accelerate recruitment. Data on physician-focused patient recruitment and the optimal approach to recruiting patients to oncology trials using both physician and patient-centered approaches will be discussed.
4:20 Opportunities and Limitations in Online Patient Recruitment for Clinical Trials
Pablo Graiver, Co-Founder & CEO, Management, TrialReach - Biography
The Internet and social media provide a unique opportunity to change patient recruitment for the better. However, while technologies and user adoption are already here, there are many other important obstacles that must be cleared before the improvement is significant and widespread.
4:35 Interactive Breakout Discussion Groups
Concurrent breakout 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 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: Social Media as a Patient Recruitment Tool
Moderator: Mark Summers, CEO & President, ThreeWire, Inc.
• The Promise of Social Media
• The Reality of Social Media
• Recommendations for Social Media
TABLE: How to Best Engage and Motivate Clinical Research Sites to Maximize Enrollment Potential
Moderator: Martin Tochacek, Ph.D., Patient Recruitment Specialist II, PAREXEL
• What motivates sites to recruit well?
• What challenges do sites face when trying to recruit for a specific clinical study?
• What motivational tools or tactics can we leverage to overcome challenges and maintain site enthusiasm?
TABLE: Tactics to Engage Physicians in a Clinical Trial
Moderator: John Eckardt, M.D., CMO, DAVA Oncology
• Explore Direct Physician Interaction
• Discuss Physician Focused Materials
• Value of Peer to Peer Meetings
TABLE: Global Clinical Trial Patient Recruitment – Challenges and New Techniques
Moderator: Nancy Mulligan, Director, Operations, Patient and Physician Services, United BioSource Corporation (UBC)
• Varying regulatory approval processes and timelines
• Differing methods to obtain informed consent
• Customized vs. tailored recruitment strategies per country
TABLE: Designing and Implementing a Clinical Enrollment Plan
Moderator: Gwen Welty, Global Clinical Site Developer, Global Clinical Site Development, Alcon Laboratories, Inc.
• Strategy development
• Plan implementation
• Patient retention
• Contingency planning
TABLE: Recruiting for Rare Disease
Moderator: Jyllian Paul, Project Manager, Client Services, BBK Worldwide
• Typically regarded as a category of research where you cannot do direct-to-patient outreach (too rare of a patient population)
• How a combination of the right sites and online awareness can help you find your patients
o Making advocacy groups work for you
o A rare disease patient is typically an educated patient – and always hungry for more information
• ROI considerations – when every patient counts, some outreach elements may still be worth the investment
TABLE: Risk Share - Divergent Definitions
Moderator: Steve Swanson, President & COO, Imperial
• Efficiencies vs. economics
• Proof tests
• Criteria for vendor selection
TABLE: Sniffing: Identifying Patients from within Study Centers Through EHR Scanning
Moderator: Lani Hashimoto, Director, Strategic Development, MMG
• Who is doing it and how
• Operational requirements
• Experience to date
5:30 Networking Reception in the Exhibit Hall
6:30 End of Day
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