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Some of the biggest challenges of delivering a successful clinical study are identifying, measuring and understanding the flow of a per protocol patient segment as it exists in the real world. This is important for selecting both the number and kind of clinical sites needed to deliver the required number of patients at the agreed recruitment rate. Understanding patient segmentation helps shape and informs your patient recruitment and retention strategy. Developing this strategy with the patient at the center is key to a successful clinical study. Patient centricity in clinical trials is at the forefront of clinical research excellence and innovation today, allowing companies to better leverage online communities, telemedicine, mHealth, EMRs and virtual trials to increase clinical trial efficiency. This conference covers how the characterization of patient segments, data-driven site selection, optimized feasibility assessment and implementation of patient-centric trial planning are improving cycle time predictability and efficient execution.
7:30 am Pre-Conference Short Course Registration
8:30 - 11:00 Recommended Short Course*
Key Technical, Scientific and Operational Considerations in Conducting a Patient-Centric Study
* Separate registration required
10:00 Main Conference Registration
Patient-Centric Trial Planning
11:05 Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, BioPharmaceutical Strategy Series, Cambridge Healthtech Institute (CHI)
11:10 Chairperson’s Opening Remarks
Adam Chasse, COO, RxTrials
11:15 Patient Centricity: The Most BASIC and LEAST APPLIED Clinical Research Concept
Marisa Co, President, National Research Institute; former Executive Director, R&D Finance, Amgen
Patient centricity in medical care is about being able to meet people’s needs such as access to information, tailored answers to questions, respect for patient’s time, education around treatment options, etc. Patient centricity in clinical trials should be no different. However, a look at study protocols tells a different story about how patient-centric we TRULY are (or are not!). In our current site-centric model, plenty of opportunities still exist to make clinical studies patient-centric.
11:45 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.
12:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
Feasibility, Assessment and Country Allocation
1:25 Chairperson’s Remarks
Stella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
1:30 The Feasibility Assessment: New Tools and Methodology to Support Your Assessment
Sameer Tandon, Global Supplier Performance & Innovation (SP&I) Manager, R&D, Novartis
The purpose of this presentation will be to provide some tactics/tips on the components of feasibility, some tools and metrics to consider, and the proper use of the Feasibility Questionnaire. The audience will gain an appreciation of current methodology in feasibility and applying some new tactics/technology in conducting their assessments.
2:00 Let’s Jam: Feasibility and Country Allocation
Jackie Kent, Director, Clinical Development Information & Optimization (CDIO), Eli Lilly and Company
There is not a single solution that will solve all of the issues with feasibility and country allocation. Come and learn about an approach to these very important factors when designing a clinical trial. The Jam process will share an innovative approach to clinical trial planning, feasibility and country allocation. It will cover information about process, information, people and technology approaches to use to help with this complex area. This solution will build better relationships between study teams and clinical operations; it will decrease protocol amendments and overall reduce cycle times within your clinical trial. It will also provide information that is more reliable and complete than in the past.
2:30 Co-Presentation: Establishing a Culture of Clinical Research in a Chronic Disease Patient Population
Jill VanDalfsen, Director of Operations, Therapeutics Development Network Coordinating Center (TDNCC)
Cindy George, Director, Clinical Research Resources, Cystic Fibrosis Foundation
Christopher Dowd, Clinical Research Program Manager, Cystic Fibrosis Foundation
The purpose of this presentation will be to discuss the origins and growth of a culture of research within the Cystic Fibrosis Foundation and community. The audience will learn about the transformation of the CF Foundation, the tools and methodologies that have been developed to increase patient engagement, the current challenges we face and the involvement of the foundation and the patient registry in the Phase 4, post-marketing arena.
3:15 Refreshment Break with Exhibit Viewing
4:00 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.
4:30 Leveraging Technology to Expedite the Creation, Distribution and Collection of Study Feasibility Questionnaires
Kevin McNulty, Director, Product Marketing, Life Sciences, Intralinks
Developing the feasibility questionnaire, distributing it to potential sites and managing the collection and analysis of the surveys is typically a manual and time-intensive process. Pharmaceutical companies and CROs are now turning to technology to streamline and automate study feasibility and site recruitment in a secure manner. This session provides a practical look at how technology can simplify and speed the process.
5:00 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.”
5:30 Networking Cocktail Reception with Exhibit Viewing
6:15 Close of Day
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