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“CHI’s Patient Recruitment in Clinical Trials offers an impressive mix of knowledgeable speakers, inspiring topical discussions, and opportunities for networking with patient recruitment leaders. This conference was instrumental in fostering strong relationships and business development, thus proving itself a not-to-be missed industry event.”
Sarah E., MBA, MPH, Director of Investigator & Patient Recruitment, Investigator Support Services
Tuesday, February 8, 2011
11:00 am - 12:00 pm Conference Registration
12:00 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on your Own
1:25 Chairperson’s Remarks
Suzanne Obst, MBA, Vice President, Corporate Strategy, McKesson Corporation
1:30 Understanding the Changing Landscape of Sites and Strategies to Adapt in Today’s Trial and Recruitment World
Gretchen Goller, Patient Recruitment and Compliance Strategist, Operations, sanofi-aventis
With today’s ongoing enrollment challenges, it is imperative that sponsors and CROs be open-minded with regard to planning their enrollment. Specifically what research sites are the best fit for any given protocol. Academic medical centers, SMOs, and other non-traditional research sites should be considered as well as viable options.
1:55 Patient Databases and Advertising Are not the only Tools to Power Recruitment: A Review of Clinical Trial Recruitment Strategic Planning
Manley Finch, Vice President, Clinical Research, Clinical Research Solutions, SleepMed, Inc.
Published literature documents a wide variance in the recruitment source of clinical trial subjects within and across disease indications. Variance outside of disease prevalence can be accounted for by many factors; trial design, seasonal, competing trials, recruitment planning, trial management competency, and others. Regardless, the commonly accepted recruitment mainstays are investigative site patient databases and advertising. Industry averages reveal that over 80% of clinical trials are delayed due to poor enrollment; clearly the mainstay recruitment practices require augmentation. This review will focus on powerful adjunctive and supporting initiatives that will accelerate enrollment velocity. A brief case study follows.
2:20 Beyond Posters and Brochures: Using Data, Expertise, and Common Sense to Drive Toward Patient Recruitment Success
Jeffrey Zucker, Senior Director and Global Head, Patient Recruitment, Kendle With the increased complexity of clinical trial design and the trend toward more targeted patient populations, using the same old methods of determining feasibility and developing patient recruitment plans will only lead to failure and timeline extensions. Employing historical data as it relates to enrollment feasibility, identification of countries and sites, and development of a specific and targeted patient recruitment plan is essential to enrollment success. This session covers how key data is gathered and used in protocol development and implementation, and how to avoid failure through proactive and contingency-based planning.
2:45 Afternoon Refreshment Break in Exhibit Hall
3:15 Anticipating IRB Requirements: Fast Track Tips
Richard Penson, M.D., M.R.C.P., Clinical Director of Medical Gynecologic Oncology, Massachusetts General Hospital; Chairman of Dana Farber / Harvard Cancer Center IRB panels C,E, and F
What strategies are optimal for avoiding the anticipated delays navigating IRB approval and study activation? How can protocols be simple, efficient and effective while still protecting participant safety? The NCI has approved a 6 month trial activation deadline that has focused concerns about delays, and is improving the culture invested in streamlining SRC, and IRB review. This session will review data, and suggest strategies aimed at stripping out redundancy and confusion and getting the job done.
3:40 Emerging Trends in Sponsor-Investigator Partnerships in Global StudiesSponsored by
Bonnie Brescia, Founding Principal, BBK Worldwide
This presentation will offer new ideas to consider regarding the nexus of the short- and long-term needs for these critical members of the clinical study community -- and the impact of operational and/or business decisions on study recruitment. Key issues to be discussed include: Conflicting financial pressures and their impact on study enrollment; Who owns the relationships with investigators? Sponsor or CRO?; How can we integrate recognition and consequences with regard to patient enrollment?; What can we do to align long-term interests for faster study start-up and improved enrollment?
4:05 A New Approach to Pharmacy-Based Recruitment: The McKesson StudyLink Program
Suzanne Obst, MBA, Vice President, Corporate Strategy, McKesson Corporation
J. Daniel Jones, Senior Global Program Manager, Cardiovascular, Metabolic, Critical Care Division, PPD, Inc.Combining robust patient data with strong pharmacist-patient relationships is proven to more efficiently identify, qualify and engage the right patients for clinical studies. Hear sponsor/CRO viewpoints and learn from case studies demonstrating increased recruitment rates and the potential for reduced study timelines. In addition, gain a better understanding of the critical role that pharmacists play as a trusted healthcare provider for many patients, and their particular ability to reach diverse patient populations.
4:30 Informal Break-out 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.
TOPIC 27: Leveraging Social Media for Clinical Trial Recruitment
Moderator:Bonnie Brescia, Founding Principal, BBK Worldwide
• How are healthcare consumers using the Web, and social networking sites in particular, to evaluate their options for care?
• What are the best strategies for using Internet techniques as part of a patient recruitment plan?
• What are the elements of online social media that can be leveraged for clinical trial recruitment?
• Do we really have to consider social media?
TOPIC 28: Trends in Planning and Executing Global Patient Recruitment and Retention Strategies
Moderator:Diana Anderson, CEO and President, D. Anderson & Company
• Metrics supporting country use of recruitment and retention strategies
• How do we address the challenges to improve minority participation in clinical trials?
• How global strategies are delivered from a U.S. perspective
• Case Study: Comparative data on sites’ perceptions and application of specific recruitment strategies
• The CRA’s essential role in global execution
TOPIC 29: Clinical Trial Implementation: Difference Makers for Launching a Successful Trial
Moderator: Marlene Peters Lawrence, NIH
• Clinical trial planning committee should include a recruitment specialist team to assist sites with delivery of trial advertisement. (Outline plan to facilitate recruitment/retention of subjects)
• Can the drug company project manager provide solutions to challenges a CRO coordinator is experiencing at their site? (Problem area. answer is NO!)
• Drug Company should incorporate a Research Nurse coordinator who has expert knowledge on clinical trial implementation and management. (Identify barriers and assist with operation)
TOPIC 30: Mining Patient Records for Recruitment
Moderator: Nariman Nasser, Director, Participant Recruitment Service Clinical and Translational Science Institute University of California, San Francisco
• How does HIPAA impact the way patient records should be searched?
• What methods put the clinic/institution at risk?
• What are some of the ways that protected health information (PHI) can be breached?
• What are some of the ramifications of improper use of protected health information (PHI)?
• How can we responsibly mine patient records to conduct recruitment?
TOPIC 31: How is Online Affecting Clinical Development Today..and What Does The Future Hold?
Moderator: Scott Connor, Vice President, Marketing, Acurian, Inc.
• Is online a clinical development opportunity or lightning rod for study teams?
• Which online strategies and tactics are deemed most effective in advancing clinical trial patient recruitment?
• Are sponsors building internal expertise/teams within clinical (as they have within marketing) to address the potential of online?
TOPIC 32: Breakdown of the Leading Global Recruitment Tactics by Type, ROI and Geographic Acceptance
Moderator: Lisa La Luna, SVP ePharmaSolutions
• Major media – TV, Radio, Print - where and when to use each tactic and average ROI
• Internet and Social Media – does it work and what can you expect
• EMR and Claims Data – leveraging 80 million patient records matched by physician
• Study Education Material – more than just physician office posters
• Referral Network – the source of most patients according to leading sites
• Opt-in Patient Databases – the diseases most suited for this tactic and estimated yield
TOPIC 33: The Expanding Role of the Pharmacist in Clinical Studies
Moderator: Steve Hoffman, Senior Vice President & Chief Pharmacy Officer, McKesson Patient Relationship Solutions
• Discuss the evolving role of the community pharmacist as the most accessible and trusted healthcare provider for patients
• Discuss the advantages of leveraging their unique position in the changing healthcare landscape to help educate, identify, counsel and refer patients to clinical studies
• Hear about new models for pharmacy based recruitment services, and the results from using actively engaged pharmacists in the McKesson StudyLink program
TOPIC 34: Performance Indicators for Site Selection
Moderator: Lani Hashimoto, Director, Strategic Development, MMG
• Discuss available data sources for site selection analytics with benefits and weaknesses for each
• Consider key past performance measures and how to relate them to site selection from both selector and site perspective
• Application of these indicators in feasibility, site selection and start-up planning
5:30 pm - 6:30pm Networking Cocktail Reception