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Wednesday, October 23, 2013
7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:25 Chairperson’s Opening Remarks
Jackie Kent, Director, Clinical Development Information & Optimization (CDIO), Eli Lilly and Company
8:30 Benchmarking Patient Recruitment and Retention Practices
Mary Jo Lamberti, Ph.D., Senior Project Manager, Tufts CSDD, Tufts University
Tufts CSDD initiated a working group of 12 biopharmaceutical companies and CROs to gather critical patient recruitment and retention benchmark metrics. Tufts CSDD collected and analyzed global trial data from 151 studies completed between 2008 and 2010. Phase II-IV study data was collected and analyzed across five therapeutic areas. Researchers examined a variety of variables including enrollment rates and timelines, activation rates and drop out and completion rates by region and therapeutic area. Analyses of activation rates and enrollment achievement rates revealed differences by region and by therapeutic area. Centralized recruitment and retention tactics across studies were also examined by region and therapeutic area. Despite numerous tactics available, participating companies indicated using a small number of patient recruitment and retention tactics. The relationship between recruit tactics and enrollment was also explored.
9:00 Using Predictive Indicators to Measure Recruitment Vendor Performance
Elizabeth Mascherino, Associate Director, Clinical Operations, Shire Pharmaceuticals
Preventative screenings are an important part of managing our health. Screenings identify potential health problems before they develop or worsen and when they are easier to treat. Why not apply the same principles to the management of central recruitment campaigns? Predictive indicators can results in early detection of recruitment campaign results and allow for course correction before your campaign needs “resuscitation.”
9:30 Case Study: Enrollment Forecasting Pilot
Amy Loescher, Director, Clinical Trials Innovation, Janssen R&D
This presentation will share the successful execution of a very rigorous pilot within Janssen R&D of a major, commercially available enrollment forecasting software. This pilot (complete with hypothesis, objectives, test plan, result, analysis, conclusion) creates a clear business case / recommendation for next steps and blueprint for scale-up, and it is critical in gaining commitment to make a process-related investment in tight budgetary times, in a large R&D organization.
10:00 Sponsored Presentation (Opportunity Available)
10:30 Coffee Break with Exhibit Viewing
11:00 Challenges and Approaches to Increase Recruitment and Retention of Minority Patients in Clinical Trials
Gerson Peltz, M.D., Medical Director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb
Addressing diversity in clinical studies is a key factor to understand and improve individual patient outcomes. Barriers for enrollment of minority patients should be taken into account when planning clinical studies in order to reduce underrepresentation of diverse racial/ethnic populations. Sponsors and investigators need to work collaboratively in developing innovative approaches to improve individual outcomes for ALL patients.
11:30 Setting Achievable Accrual Goals for Minorities and Women: The Significance of Population Demographics for Cancer Researchers
Lynne Nguyen, Director, Population & Community Core, Center for Community-Engaged Translational Research, MD Anderson Cancer Center
Low participation is associated with less access to high-quality care, and potentially contributes to health disparities. The presentation offers strategies and a systematic method for setting appropriate and achievable recruitment goals for cancer clinical trials, especially among minorities and women who have historically been underrepresented in clinical trials. This presentation will provide participants an 1) understanding of the impact of population demographics on patient demographics, 2) strategies for setting achievable and appropriate clinical trial accrual goals for minorities and women, and 3) strategies for determining equitable participation.
12:00 pm What Sponsors/CROs Overlook: How Socioeconomic Status, Residential Segregation, and Immigration Patterns Impact Study Enrollment
Rebecca Budd, MBA, Managing Director, Navita Clinical Strategy Group
The 2010 Census has provided an overwhelming amount of new data to assist sponsors/CROs with study planning, site selection and patient recruitment. Sponsors/CROs utilize Census geographic data (population counts and density) in strategic planning but often overlook important demographic data such as socioeconomic status, residential segregation, and immigration patterns in the process. This presentation will provide participants with an overview of these overlooked variables and how they impact study enrollment, especially of minority groups.
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:40 Chairperson’s Remarks
Jane Perlmutter, Ph.D., President and Founder, Gemini Group; Steering Committee Member, Clinical Trials Transformation Initiative (CTTI)
1:45 Case Study: Pilot Project to Utilize a Social Media Platform for Sponsors and Investigator Site Personnel
Chris Conklin, Associate Director, Clinical Research, Global Trial Optimization, Merck
The presentation will share the results of a pilot project Merck is conducting with internal team members and an external partner. The pilot’s goal is to utilize technology and new media to improve enrollment and overall trial execution through improved communications between, sponsor headquarters team, field and investigator site personnel.
2:15 The Impact of Informatics on Clinical Trial Feasibility and Subject Recruitment
Damon Michaels, Director, Clinical Trials Research, Vanderbilt University Medical Center
Informatics plays a key role in developing and administering a successful clinical trial. It helps form the basis for determining the optimal patient population to test a research hypothesis. Once the trial has opened, informatics helps to identify patients that will meet inclusion criteria and significantly reduces labor costs for screening.
2:45 Methods to Improve Clinical Trial Recruitment
Janet Flisak, Director, Clinical Research, Johnson & Johnson
3:15 Case Study: Leveraging a Participant-Controlled Registry to Create Cohorts and Enable Clinical Trials
Greg Biggers, Reg4ALL / Genetic Alliance
3:45 Technology and Tools that Support Agile, Evidence-Based Recruitment Methods
Nariman Nasser, Senior Director, Recruitment & Implementation Core, Clinical Research Services, Clinical & Translational Science Institute, University of California San Francisco
Ongoing challenges to recruiting clinical trials leave us constantly seeking new recruitment methods. But having the right tools to quickly and effectively evaluate ongoing methods is key to making time- and cost-saving decisions about your recruitment campaigns. This session will provide information on technology platforms and basic tools available to help you manage your recruitment campaigns real-time.
4:15 Chairperson’s Closing Remarks
4:30 Close of Evidence-Based, Data-Driven Patient Recruitment and Retention Executive Forum
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