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Tuesday, October 22, 2013
Data-Driven Site Selection
7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:25 Chairperson’s Remarks
Tania Bojanowski, Director, Development Operations & Strategic Planning, sanofi oncology
8:30 Using a Data-Driven Approach with Sites during the Feasibility Process to Help Ensure a More Accurate and Successful Trial Outcome
Nicole Burgeson, Site Director, RxTrials
Many Sponsors/CROs do not effectively challenge sites to think through their enrollment estimates during feasibility and site selection. Given the inexperience and nonperformance within the investigator pool, industry cannot rely on sites to provide well-reasoned recruitment projections. Therefore, sponsors and CROs must design feasibility methods that force sites to take a data-driven approach to their estimates by asking for specific numbers that come directly from EMR or chart reviews.
9:00 Mapping Chronic Disease for Efficient Identification of Clinical Trial Outpost Development
Les Jebson, Director, University of Florida - Pathology, University of Florida Academic Health Center
With the implementation of the internet and growth of factors such as population, and analytical resources, and the need for comprehensive clinical trial populations, identifying best practices for establishing clinical trial outposts is paramount. Establishing clinical trial outposts in countries around the world has numerous benefits and drawbacks, including but not limited to ethical, legal and cultural implications. This presentation discusses novel strategies for preemptively researching and identifying regions in which to establish clinical trial outposts.
9:30 Why Patients Leave Clinical Trials and How to Better Engage Them
Ed Watson, Senior Director, Acurian
Early termination from clinical trials is a serious problem. First we need to understand the exact reasons why people enter trials and, in particular, why they drop out. This session reveals the results of a September 2013 survey of clinical trial participants that provides these patient insights and more. Also included is a recent case study exploring patient engagement for a large, cardiovascular outcomes study and the surprising data that resulted, along with a quantification of the cost savings attributed to strategic retention support.
10:00 Coffee Break with Exhibit Viewing
Patient-Centered Tools and Media
10:45 Advancing Patient Recruitment and Retention through Patient-Controlled Medical Records
David Beyer, Vice President, Patients Know Best
The real potential for successful patient recruitment and retention lies in a patient-centric online personal health record shared with the patient's clinical and personal community simultaneously. We have evidence that working in this fashion helps clinical trials to advance beyond the one-dimensional view offered by patient profiles, the low retention and engagement generated by the current EMRs and the shortage of clinically verifiable information when online communities are used to target populations. Patients Know Best is the world's first personal health record system that allows patient control of their medical data and true partnership with their clinicians as well as researchers. A patient-controlled medical record that tracks symptoms, treatment and patient outcomes allows patient data to be released from institutional silos and be tracked wherever the patient may be, whether in a healthcare setting or at home. With a simple two-step consent process, the patient can socialise anonymous portions of their data for research and participate in patient-centric research.
11:15 Optimizing Social Media in Clinical Research
Stella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
The emergence of interactive web-based communities has introduced a host of opportunities and major challenges with respect to program planning, patient recruitment and pharmacovigilance. Although these communities play a growing role in clinical research, no standard policies and practices have been established to guide clinical research professionals. Tufts CSDD, with the help of a working group of pharmaceutical executives, has gathered primary and secondary data and will glean proposed principles and standard practices involving social media.
11:45 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.
Special Luncheon Presentation
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.
New Approaches to Improve Clinical Trial Operations and Strategy
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 Refreshment Break with Exhibit Viewing
3:30 Aligning Strategy and Operations to Accelerate Drug Development
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.
4:00 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.
4:30 Technology and Tools that Support Agile, Evidence-Based Recruitment Methods
Nariman Nasser, CCRP, Founder, Only For Good; Digital Strategist, Product Development, Genentech
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.
5:00 Close of Patient Centricity in Developing Strategies for Trial Execution Forum
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