Cambridge Healthtech Institute’s Seventh Annual
Enrollment Planning and Patient Recruitment
Successfully Planning, Managing and Measuring Campaign Performance
February 4-5, 2014 | Hyatt Regency Miami | Miami, FL
Patient recruitment and up-front enrollment planning are critical to drug development programs. Patient recruitment if not adequately planned for can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for your analysis and subsequent filings. In order to optimize both you have to have a plan. CHI’s 7th Annual “Enrollment Planning and Patient Recruitment: Improving Strategic and Operational Approaches to Reach Study Goals” will cover the topics one should consider when drafting and strategically implementing a patient recruitment plan for a clinical development program.
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WEDNESDAY, FEBRUARY 5
7:30 am Breakfast Presentation: Operations Optimized: How Sponsors Use Novel Technology to Optimize Start-Up, Enrollment, Retention, Site Engagement, Conduct and Closeout
Eric Silberstein, Co-founder & CEO, TrialNetworks
Clinical trials are among the most important activities the world performs, yet the processes driving them are traditionally manual, redundant and inefficient. Novel technology systems are enabling sponsors to collaborate with sites and CROs to optimize key aspects of a trial from startup to closeout – including site activation, patient recruitment and retention, site engagement and conduct. This session will present several case studies featuring evidence-based results achieved by sponsors using optimization systems in global trials.
8:10 Chairperson’s Remarks
Ramita Tandon, Senior Vice President & General Manager, Patient Outcomes, inVentiv Health, Inc.
8:20 Boosting Subject Retention with Automated Reimbursement & Messaging Technology
Kelly McKee, Associate Director, Clinical Research, Global Trial Optimization, Merck & Co., Inc.
This discussion will focus on how to leverage technology to automate compensation of subjects and subject messaging in clinical trials. The discussion will focus on challenges inherent in manual compensation systems given the increasingly complex nature of clinical trials, and how technology systems can be used to increase patient retention in a trial, as well as potential other benefits and challenges of using an automated system. The discussion will explore the site, sponsor, patient, and technology provider perspectives.
8:45 Case Study: Text Message Recruitment
Elizabeth Mascherino, Associate Director, Clinical Operations, Shire Pharmaceuticals
Text messaging continues to be a growing means of communication. Many case studies exist for how text messaging has been used to retain patients and promote engagement. But few examples have been shared about how text messaging can serve as a vehicle to drive response from an advertising campaign. During this case study we will review how patients respond via text, how the system engages patients in an interactive screening and finally, how text messaging stacks up against more traditional methods of response.
9:10 Empower Evidence-Based Feasibility Research and Enrollment Planning through Analytics
Jane Fang, Ph.D., R&D IS Lead, Clinical Business Management & Analytics, MedImmune
Going beyond the traditional trial feasibility and enrollment planning approach, we use internal and external data and informatics tools to enable data-driven trial feasibility evaluation and enrollment projection.
9:35 Sponsored Presentation
Speaker to be Announced
9:50 Coffee Break in the Exhibit Hall
10:40 Chairperson’s Remarks
10:45 Factors Affecting Recruitment into Depression Trials: Systematic Review and Meta-Synthesis of Qualitative Evidence
Adwoa Hughes-Morley, NIHR Doctoral Research Fellow, MRC North West Hub for Trials Methodology Research, Centre for Primary Care, Institute of Population, The University of Manchester
There is a need for new, effective treatments for depression. However poor recruitment and retention in depression trials is a widespread problem, and depression trials often fail to recruit their target sample of participants to target, or indeed fail altogether. This systematic review is the first to address factors affecting recruitment into depression trials. It identifies both barriers and facilitators in recruiting into depression trials, which will be of relevance and interest to all those undertaking clinical trials in depression. Implications to other disease areas will also be considered. The review will further explore how finding can be applied pragmatically to develop interventions for effectively recruiting participants into mental health trials.
11:10 Co-Presentation: Using EHR at Multiple Healthcare Sites to Identify Sites and Recruit Patients in a Phase III Clinical Trial: Perspectives from the Vendor and Sponsor
Zhaohui (John) Cai, M.D., Ph.D., Director, Biomedical Informatics, Clinical Medicines Development, AstraZeneca Pharmaceuticals, Inc.
Aaron Kamauu, M.D., President & CEO, Anolinx, LLC
For a few years now, the industry has looked forward to leveraging electronic health records (EHR) in support of selecting clinical trial sites as well as identifying and recruiting eligible patients. However, previously published/presented examples include only a single or few sites and have focused primarily on the technical aspects of an EHR-baseddata-driven approach. Little has been shown for implementing this approach at multiple sites from different healthcare institutions using different EHR systems for the same clinical trial. This presentation will share a real example of this approach applied to two phase 3 clinical trials. It will present metrics from those data-driven sites as well as lessons learned. The two presenters will provide the perspective from both the vendor and the sponsor.
11:35 PANEL: The Great Debate
Colin Scott, M.D., Senior Director, Respiratory Development, Clinical Development, Forest Research Institute, Inc.
Sarah Luijpers, Director, Global Recruitment Operations, Forest Research Institute, Inc.
This session will be a pro and con debate and interactive discussion with attendees focusing on key topics covering the three main areas of recruitment: where do we get patients, how do we reach more patients, and who do we entrust the trial management to? Topics to be discussed:
- This House believes that the day of the independent investigator is over: Pro: - C. Scott, Con: - S Luijpers
- This House believes that traditional methods of recruitment will be superseded by a full blown multimedia outreach approach: Pro: - S. Luijpers, Con: - C. Scott
- This House believes that only large CROs with a global reach can manage late stage development studies: Pro: - C. Scott, Con: - S. Luijpers
12:00 pm Sponsored Presentation (Opportunity Available)
Bridging Luncheon Presentation between Enrollment Planning and Subject Retention
12:15 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.
1:00 Close of Conference
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