Cambridge Healthtech Institute’s Inaugural
Subject Retention and Compliance in Studies and Registries
Engaging and Empowering Patients through Mobile and Social Platforms
February 5-6, 2014 | Hyatt Regency Miami | Miami, FL
Enrollment planning and patient recruitment are critical to drug development programs and garner a lot of attention by study teams. However, once the hard work of identifying and recruiting a trial subject has been accomplished they must be retained and remain in compliance. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for your analysis and subsequent filings. There are strategies, tools and techniques such as social media platforms and mobile technology, empowered patient communities, and a more informed patient population that need to be understood and engaged. CHI’s Inaugural “Subject Retention and Compliance in Studies and Registries” will cover the topics one should consider when planning and strategically implementing a patient retention plan in the digital age.
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WEDNESDAY, FEBRUARY 5
Bridging Luncheon Presentation between Subject Retention and Enrollment Planning
12:15 pm Luncheon Presentation: Ensuring Site Buy-In and Compliance through Successful Execution of Recruitment and Retention Planning
Melynda Geurts, Vice President Operations, DAC Patient Recruitment Services
The equation for a successful study consists of a solid protocol, committed research centers and volunteers. It requires the right ratio to yield desired results. During this presentation we will explore how the right level of recruitment and retention planning during protocol design can enhance site buy-in and study compliance. Integration of case studies will review the following steps: 1) when to plan, 2) what to plan, 3) how to implement the plan, and 4) how to engage the sites. Lastly, we will examine how study coordinators are their own best advocates for site motivation.
1:20 Chairperson’s Opening Remarks
Barbara Wuebbels, Vice President, Patient Advocacy and Medical Affairs, Audentes Therapeutics
1:30 What Does Patient Centricity Mean to Patients?
Jane Perlmutter, Ph.D., MBA, President and Founder, Gemini Group; Steering Committee Member, Clinical Trials Transformation Initiative (CTTI)
“Patient Centricity” is a “motherhood and apple pie” concept, but means different things to different people. This session will explore what patients and patient advocates mean by “patient centricity,” and how this may differ from what clinical trialists mean. In addition, we will consider implications for planning and implementing clinical trials that will rapidly accrue patients.
1:55 Understanding Various Types of Patient Advocacy: Partner with and Engage Patient Opinion Leaders (POL) and Patient Advocacy Groups to Further Research
Rose Gerber, Director, Communications and Patient Advocacy, Community Oncology Alliance
For organizations interested in engaging patients as partners and advocates, it is fundamentally important to understand the many distinctions between the various types of patient advocacy. Advocacy is present in many forms and can include peer based support advocacy, educational advocacy, policy based advocacy and research based advocacy. In this session attendees will also be provided with an overview of the opportunities and challenges in working with patient advocates.
2:20 Six Degrees of Kevin Bacon – Building Lasting Connections with Advocacy Groups
Aaron Fleishman, Social Innovation & Advocacy Engagement, BBK Worldwide
Lasting relationships with patient advocacy and community groups can be an important part of a patient recruitment program. The question is, how do you build those relationships? And once you’ve built them, how do you maintain them? Aaron Fleishman from BBK Worldwide will discuss several ways you can work with advocacy groups as a patient recruitment tactic.
2:45 Accelerating Recruitment in Complex Clinical Trials: How Clinical Trial Educators Can Help
Stewart Rosen, M.D., Vice President, Medical Affairs, Health Management Solutions, Quintiles
Challenges in recruiting and retaining patients for clinical trials continue to cause delays. There is a need for a more effective method to recruit patients, shorten development timelines, decrease costs, and increase the pace at which new medicines become available to patients. To date, the CTE solution has been successfully used in trials with a complex patient pathway in therapeutic categories that are also highly competitive, including oncology, CNS, and cardiovascular diseases. CTEs have been highly effective in rescuing trials. This presentation will showcase the effectiveness of Clinical Trial educators in driving patient recruitment and retention in complex trials.
3:10 Refreshment Break in the Exhibit Hall
4:00 Chairperson’s Remarks
Judith Teall, Director, Clinical Excellence, Exco InTouch
4:05 Initiating a Proactive, Multi-Faceted Patient Retention Plan: Challenges, Opportunities and Case Studies
Kelly McKee, Associate Director, Clinical Research, Global Trial Optimization, Merck & Co., Inc.
Patient retention planning and management is just as important as patient recruitment and requires a study-specific, patient-focussed, and success-driven action plan. This presentation will focus on the challenges and opportunities one must consider in designing and initiating an effective recruitment plan and will provide case studies to demonstrate the impact of patient retention planning.
4:30 CO-PRESENTATION: Patient-Centricity and Marketing the Site to Increase Recruitment and Retention: A Coordinator’s Perspective
Jessica Saucier, Clinical Transplant Research Nurse, Baylor Research Institute
Erin Fassett, Clinical Transplant Research Nurse, Baylor Research Institute
By integrating successful recruitment tools into practice, the site can increase screening numbers and reduce the time to completion of enrollment. In addition, strategies to market the site can be implemented to ensure rapid identification and utilization by the sponsor. This dual-component recruitment plan can be utilized by sites to increase their visibility, reduce the time sponsors spend identifying quality sites, and assist the research industry by increasing subject enrollment in an era troubled by falling rates.
4:55 Harnessing the Momentum of Patient Centricity and Social Media for Patient Recruitment
Liz Moench, President & CEO, MediciGlobal, Inc
The conduct of clinical trials is undergoing rapid change, fueled in part by technological advancements, and an increasingly empowered patient population. While many biopharmaceutical companies currently use a form of direct-to-patient for certain clinical processes, such as online patient recruitment, there are growing opportunities to implement patient centric initiatives across the clinical trial model. From this panel, participants will learn how to: enhance clinical study planning and modeling through patient centric initiatives; optimize social media for added efficiency in clinical trials & utilize direct-to-patient channels for identifying, recruiting and retaining trial participants.
5:20 Networking Reception in the Exhibit Hall
6:20 End of Day
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