4:00 Interactive Breakout 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: Strategies for Clearly Defining and Managing the Protocol Development Process
Moderator: Nariman Nasser, Director, Participant Recruitment Service Clinical and Translational Science Institute, University of California, San Francisco
• Selecting sections to address first
• Consistency without redundancy
• Key milestones for circulation and comment on major revisions
TABLE: Lessons Learned from Protocol Amendments and Understanding What Makes a Protocol Unexecutable
Moderator: Beth Harper, Chief Clinical Officer, Centerphase Solutions, Inc
• What are the main “disconnects” between scientifically eloquent studies and operationally unexecutable protocols?
• Data from TUFTS CSDD suggests the majority of protocol amendments can be avoided; how does this compare to your experience?
• Hindsight is 20:20 – based on your recent experiences with amendments, could you have prevented these? What could have helped you avoid these and how will you approach your next study differently?
TABLE: Identifying Key Stakeholders, Integrating Feedback and Monitoring Change Throughout the Research Process
Co-Moderator: Laurie Lebo, Ph.D., CCRP, PMP, Research Services, Vanderbilt University Medical Center
Co-Moderator: Paul Hoskins, Head, Clinical Operations and Preclinical Outsourcing, Galleon Pharmaceuticals
• Who are the key stakeholders of your project/study?
• What is a stakeholder analysis (Interest/Influence Grid)? How do you complete one, and what do you do with the results?
• What is a change control board? Why do you need one?
TABLE: How to Manage the Protocol Development Process with Outsourced Writing Resources
Moderator: Cheryl Vitow, Consultant Medical Writer and Clinical Science Manager, Clinical and Medical Affairs, Ortho Clinical Diagnostics
• How to find a good match for your needs when looking for an external writing resource
• Timing and how it impacts the end result
• Who is running the show when using external resources for writing protocols (CRO or independent medical writer)
TABLE: Complementing Process Improvements with Technology for Protocol Design
Co-Moderator: Suzanne Collins, Director, Operations, Trifecta Multimedical
Co-Moderator: Penny Carlson, Global Clinical Program Manager, Consultant, Genzyme, Inc.
• What changes have you made to optimize the protocol design process?
• What has been the most successful process improvement and why?
• How can the use of technology help you streamline the process?
TABLE: Strategies for Proactive Issues Management and Resolution Strategies for the CRA
Moderator: Kristopher Chrisman, CCRP, Senior CRA, Metabolism & Diabetes/Internal Medicine, US Clinical Research, sanofi-aventis
• What are the tactics in training and retraining?
• Spotting trends with a study and proactively training sites
• Who should be involved with the management of issues and resolution strategies to those issues?
TABLE: Effective Study Site Evaluation Plan Development and Implementation
Moderator: Christopher Beardmore, President and CEO, Oncology, Translational Research Management, LLC
• How do you define the goals and objectives of a site evaluation plan?
• Should goals and objectives apply to a variety of organization types?
• Does conducting site evaluation inherently improve quality?
• Do quality site evaluation plans have common threads to connect organization types?
• How should evaluators be trained to provide consistent site evaluation?
TABLE: New Recruitment Tools are Available, Yet are They Providing Results for the Site and Industry?
Moderator: Joan Chambers, COO, CenterWatch
• New strategies around internet, data mining, matching services, patient databases, and collaborations – is one strategy more effective than others?
• Are these strategies boosting patient enrollment and retention rates? Is there a measurable difference?
• Is convergence of the patient community and industry the strategy for clinical trial success and if so, how is that obtained?
TABLE: Site Relationship Management: Selecting the Right Sites for Your Study
Moderator: Chris Hoyle, M.B.A., Executive Director, Elite Research Network
• Innovative approaches to communicating information to sites in order to make better decisions
• Cost cutting approaches to Sponsor/CRO and site relationships
• Measuring KPIs to improve investigator site selection process.