The average cost of clinical trials has risen to nearly 60% of total development costs. Patient recruitment delays and a low retention rate are key factors in this increase of costs, leading to a delay in product launch and a subsequent reduction in product exclusivity. Patient recruitment, if not adequately planned and managed, can extend the development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential to obtaining the best data sets for analysis and subsequent filings. In order to optimize both recruitment and retention there needs to be a plan and performance management approach based on evidence, data and a set of tools you know will work. This conference is intended to cover the latest differentiators in recruitment and retention; the newest opportunities in online social networks, EMRs and Big Data to support decision making; evidence-based identification and selection of investigators; recruitment of special populations; and lessons learned from various therapeutic areas. “Evidence-Based, Data-Driven Patient Recruitment and Retention” will provide a comprehensive real-world perspective on this challenging arena, with key takeaways you can implement right away to ensure the best results.
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Tuesday, October 22, 2013
12:15 pm Luncheon Presentation:
Using Insurance Claims and Electronic Health Records to Ensure a Patient-Centric Trial
Bill Gwinn, MBA, Vice President, Clinical Informatics Solutions, OptumInsight
Year after year, about half of trials run late, but it will not stay that way. There is an explosion in quantitative information that can result in better planning and execution, for faster trials. The presentation will start with planning feasibility with insurance claims and electronic health records, including statistical projections of disease prevalence. For recruitment, the session will teach how to “fish where the fish are” to find patients. Techniques include ranking areas and investigators based on patient count. A new application will show how to improve media placements to reach the actual patients and improve response rates.
1:25 Chairperson’s Remarks
Elizabeth Mascherino, Associate Director, Clinical Operations, Shire Pharmaceuticals
1:30 Co-Presentation: Patient Centricity in Developing Strategies for Trial Design and Execution
Christine Dehner, Senior Clinical Trial Manager, Clinical Ops, Seattle Genetics, Inc.
Marta Fields, Director, Compliance and Quality Systems, Seattle Genetics, Inc.
Keeping the patient in mind when designing and executing a clinical trial is a multi-step process and is not just about patient convenience. Patients knowingly assume a risk when deciding to participate in a clinical trial, since the treatment by its very nature is experimental. Poorly designed and executed clinical trials could result in data that cannot be analyzed or leads to incorrect conclusions. If this occurs, the patient participation did not help further science. Designing protocols utilizing “Quality by Design” prior to protocol finalization helps identify early on “errors that matter” and how to mitigate the risks using feedback from key team members. Team members are not just the internal team at a sponsor and key opinion leaders, but should also include the nurses that carry out the day-to-day activities. Patient advocacy groups can also be utilized to further understand what is important to the patient.
2:15 Why the Evolution of Site Evaluation/Selection Has Been Counterproductive, and How Industry Must Adapt
Adam Chasse, COO, RxTrials
Over the past 20 years, as the business of clinical research has matured, industry has been forced to demonstrate operational scalability in order to keep up with growth. Site evaluation and selection—arguably the most important element of any study—is a prime example of this. Industry has focused vast resources on database development, predictive analytics, and "assembly line" approaches—all of which have shaved time off the process and allowed increasingly junior (i.e., cheaper) members to handle this function, yet enrollment metrics have not changed meaningfully. This primarily relates to industry's lack of knowledge of how sites integrate research into their clinical practice—which is the primary driver of recruitment success or failure. Industry must take a more qualitative approach to site evaluation and selection if it is to complete studies on time and within budget.
2:45 Industry Update on the TransCelerate Investigator Portal Project
Jackie Kent, Director, Clinical Development Information & Optimization (CDIO), Eli Lilly and Company
3:00 Aligning Strategy and Operations to Accelerate Drug Development
Tania Bojanowski, Director, Development Operations & Strategic Planning, sanofi oncology
Aligning strategy and operational implementation early in the development process is essential to ensure fluid functional transitions crucial for accelerated drug development. Lack of planning and involvement of key interfaces and functions at the right time can create delays and “white space” ultimately impacting pivotal study execution and completion. Integrated Drug Development Plans are key documents that provide a global and integrated vision for all team members to follow. This” play book” for projects defines decision points, the project target product profile (TPP) and market access objectives. It links pivotal development activities needed to fulfill the ultimate objective of bringing novel therapies to patients as quickly as possible. This presentation will review the reasons why most companies fail to deliver a clinical strategy and will define ways to align operational strategy with proper attention to /key stakeholder insights and a proposed action plan to avoid these pitfalls.
3:30 Refreshment Break with Exhibit Viewing
4:00 Interactive Breakout Discussions
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions.
TABLE: TransCelerate Investigator Portal Project
Moderator: Jackie Kent, Director, Clinical Development Information & Optimization (CDIO), Eli Lilly & Co.
- Overview of TransCelerate and 5 workstreams
- What is the Investigator portal
- Roadmap and timelines
- Q & A/open discussion about the change management associated with this project
TABLE: Health-Focused, Online Social Networks and Their Role in Clinical Research
Moderator: Les Jebson, Director, University of Florida - Pathology, University of Florida Academic Health Center
- Understanding and engaging in the emergence of online health social networks formed around specific medical conditions or health interests
TABLE: Patient-Centricity within the Current Site-Centric Model: Plenty of Opportunities for Significant Improvements!
Moderator: Marisa Co, President, National Research Institute; former Executive Director, R&D Finance, Amgen
- Patient centricity in minority recruitment – approaches that work…and those that don’t
- Sponsors/CRO processes are built for standardization while patient centricity requires flexibility and customization. Are sponsors/CROs ready for that?
- What can sponsors/CROs do to encourage minority participation?
5:00 Close of Day
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