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 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 27: Tylenol for IRB Headaches!

Moderator:  Richard Penson, M.D., M.R.C.P., Clinical Director, Medical Cynecologic Oncology, Massachusetts General Hospital, Chairman of Dana Farber/Harvard Cancer Center IRB panels C, E and F

• Plan for success
• Common pitfalls
• Communicating with IRBs

TABLE 28: Identification and Selection of Investigators: Do They Really Have Patients?

Moderator:  Nariman Nasser, Director, Participant Recruitment Service, University of California, San Francisco

• How to design a site feasibility questionnaire to get the most useful data
• Going beyond the chart review to quantify the available patient base
• Comparing aggregate site data to local incidence rate to accurately project patient numbers

TABLE 29:  Patient Recruitment - Challenges and New Approaches

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 30: Planning, Planning and Planning your Enrollment Strategy.  Learn from your Mistakes!

Moderator:  Andrew Cwiertniewicz III, Senior Clinical Trial Manager, Clinical Operations, Study management and Logistics, sanofi pasteur

• Review your metrics from past trials
• Competitive enrollment, controlled competitive enrollment, or just hope to enroll?
• Take what your sites are telling you – than halve it.

TABLE 31: Can You Hear Me Now?  Recruiting/Call Center Operations

Moderator:  Mark Metzner, Director, Recruiting & Marketing, Community Research

• Subject Impact (What Are They Expecting From Us?)
• Regulatory Impact (What Are We Allowed To Say To Them?)
• Contact Challenges (Why Do You Leave a Number Where We Can Never Reach You?)
• Your Site’s Hurdles
• Best Practices

TABLE 32:  Recruiting using a Social Marketing Approach

Moderator:  Nancy Mulligan, Director, Operations, United BioSource Corporation (UBC)

• Reaching potential patients where they are
• Delivering the right message
• Rewarding patients for their contributions (it's HIPAA compliant!)

TABLE 33:  #SYTYCR – So You Think You Can Recruit Using Social Media

Moderator:  Lani Hashimoto, Director, Strategic Development, MMG• Discuss how to you measure the impact and effectiveness of your program
• Share performance measures and share experience and expectations 
• What would make you #tweetwithjoy? 

TABLE 34:  New Challenges Call for Innovative Approaches to Patient Recruitment and Retention for Post Marketing Trials 

Co-Moderators:  Ramita Tandon, Global Head of Late Phase Clinical Trials, PAREXEL 
Lollo Eriksson, Vice President GRO, Start, Feasibility & Clinical Informatics, PAREXEL• Undertand the various types of options/cutting edge strategies (like Social Media and Electronic Medical Records) and the benefits they offer to the post marketing research enterprise and patient community
• Understand the market forces driving the need for such cost efficient patient recruitment/retention approaches and discuss the trends changing the drug this research area

TABLE 35:  Designing and Implementing a Clinical Enrollment Plan: Strategy Development, Plan Implementation and Contingency Planning

Moderator:  Bonnie Brescia, Founding Principal, BBK Worldwide• Best practices for balancing cutting edge innovations with tried and true recruitment practices
• Maximizing the impact of recruitment resources by developing strategic plan based on activation timelines and staggered program rollouts 
• Taking a proactive, data-driven approach to contingency planning and tactic

RECOMMENDED MONDAY AFTERNOON SHORT COURSE: 

Social Media and Mobile Technology in Supporting Patients in Studies and Registries