With competition for patients, clinical trial sites and investigators on the rise, the need for successful strategies for patient recruitment and site selection is crucial to the success of a clinical trial. Cambridge Healthtech Institute’s “Patient Recruitment & Site Selection” conference features best practices and case studies on successful patient recruitment and site selection techniques using a data-driven approach.
MONDAY, MAY 9
7:25 am Conference Registration and Morning Coffee
8:25 Chairperson’s Opening Remarks
Robert Loll, Vice President, Business Development & Strategic Planning, Praxis
8:30 Talk Title to be Announced
Aaron Fleishman, Technology and Product Innovation, BBK Worldwide
9:00 PANEL DISCUSSION: Innovative Approaches to Patient Recruitment
Robert Loll, Vice President, Business Development & Strategic Planning, Praxis
Aaron Fleishman, Technology and Product Innovation, BBK Worldwide
Ryan Norris, CTO, Be the Partner
With the increased industry pressure for more efficient and faster clinical trials, patient recruitment remains one area crucial to speedy study start-up. This panel will discuss revamping existing strategies and technologies to aid in patient recruitment in light of the rise and popularity of ever increasing new technologies and social media platforms from mobile apps to wearables and online patient portals.
10:00 Networking Coffee Break
10:30 Rethinking Site Selection From a Patient Lens
Abbe Steel, CEO, Corporate, HealthiVibe, LLC
What we've learned from interviewing clinical trial participants and conducting patient satisfaction surveys is that nothing affects the patient's overall study experience as much as site perception. Quality of communication, convenience, and the respect and encouragement of site staff are among the key themes we uncovered that have a direct impact on the patient’s study experience. And yet, typically the current site selection approach makes no use of patient feedback metrics, even though the potential benefits -- to patients and to study success -- are clear.
11:00 Using Technology to Drive Site Selection and Site Activation
Emma Morley, Site Identification and Feasibility Manager, DrugDev
11:30 A Breakthrough in Technology Enabled Clinical Trials Recruitment
Steven Coca, M.D., Associate Professor of Medicine, Internal Medicine, Icahn School of Medicine at Mount Sinai
12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
12:45 Session Break
1:25 Chairperson’s Remarks
Robert Loll, Vice President, Business Development & Strategic Planning, Praxis
1:30 Site Selection Insights from UCB BioSciences
Shawn Tedman, Associate Director, Site Selection Lead, Site Selection & Engagement, Global Clinical Sciences & Operations, UCB BioSciences, Inc.
2:00 PANEL DISCUSSION: New Site Selection Methods
Abbe Steel, CEO, Corporate, HealthiVibe, LLC
Emma Morley, Site Identification and Feasibility Manager, DrugDev
2:30 Refreshment Break in the Exhibit Hall
3:15 Interactive Breakout Discussion Groups
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. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.
4:15 Welcome Reception in the Exhibit Hall
5:15 Close of Day
5:15 pm Dinner Short Course Registration
TUESDAY, MAY 10
7:55 am Chairperson’s Remarks
Scott Scarola, Senior Director, Business Analytics, PPD
8:00 Data Visualization Approach to Clinical Studies Data
Mukta Tripathi, Clinical Science Visual Analytics, Genentech
The presentation will focus on implementation of a data visualization approach for safety signal detection while study is ongoing as well as visualization approach for scenario building for analyses that will be carried out for dose escalation, final analysis to name a few. At Genentech/Roche the process of individual as well as aggregate reviews has been revolutionized by implementing Spotfire for Clinical and Safety Scientists. This talk focuses on advantages of an innovative approach to clinical data visualization using Spotfire.
8:30 Clinical Visualizations Drive Decision Making in Clinical Trials and Translational Research
Philip C. Ross, Director, Data Sciences TR&D, Clinical Pharmacology and Pharmacometrics, Exploratory Clinical and Translational Research, Bristol-Myers Squibb
Clinical trials generate large amounts of data that require rapid review to identify emerging signals and trends. These signals and trends are most effectively identified using visualizations. Using the information revealed in the visualizations, clinicians and scientists can make faster, better informed decisions driving translational research and development. The integration of this data and knowledge drives the development of new treatments that will be beneficial for patients.
9:00 Big Data Analytics and Cognitive Computing in Ophthalmology: Innovation in Clinical Research and Development
P. Lloyd Hildebrand, MD FACS P-CEO, Professor, Department of Ophthalmology, University of Oklahoma
Big Data Analytics and cognitive computing create knowledge that can improve clinical decisions in clinical trials, drug development and direct patient care. Eye care industry providers Topcon (diagnostic imaging), ifa (EHR), and Inoveon (telemedicine) are partnering with the leading Big Data Analytics specialist to create the world’s first cognitive computing engine in Ophthalmology.
9:30 Raising the Bar for Central Medical Review
Victor Lobanov, Ph.D., Executive Director, Data Sciences, Covance Inc.
Periodic review of clinical data is critical for the patient safety and data quality. Covance’s Medical Review is aligned with the FDA guidance for a greater role of central monitoring and provides timely, integrated views of all relevant clinical data along with the unique, interactive capabilities to detect outliers and trends, create and analyze cohorts, execute review workflows, annotate clinical data, and communicate observations.
10:00 Coffee Break in the Exhibit Hall
10:40 Chairperson’s Remarks
Scott Scarola, Senior Director, Business Analytics, PPD
10:45 Using Advanced Software Applications to Leverage EHRs to Support Protocol Feasibility and Patient Identification
Sameer Tandon, Clinical Trial Intelligence Manager, Clinical Sciences & Innovation, Novartis
This presentation will cover the use of a software application to mine EMRs with leading academic institutions with the ability to arrange consultation and identify patients for referral into a clinical trial.
11:15 Integration of Clinical Trials into Clinical Care Using the Electronic Health Record
Mary T. Brophy, M.D., MPH, Director, Maveric Core Laboratory, VA Boston Healthcare System
This session will review efforts by the Department of Veterans Affairs to conduct clinical research as an extension of quality improvement efforts in the clinical care ecosystem. Alternatively termed pragmatic or point-of-care clinical trials, these studies are conducted less expensively and yield results that are more generalizable than traditional study designs. The session will review the Department’s efforts in cardiovascular and medical oncology investigations.
11:45 A Technology Platform for Delivering Pragmatic Clinical Trials within a Primary Care Setting in the UK, Using Electronic Healthcare Records
Tim Williams, Ph.D., Head of Research, Clinical Practice Research Datalink (CPRD), Medicines and Healthcare Products Regulatory Agency (MHRA)
The ability to use Electronic Healthcare Records (EHR) as part of a randomized interventional study has been identified as a novel paradigm to manage and deliver clinical data in a real-world setting. Our challenge was to design and build a system to deliver pragmatic trials based on primary care EHR. This resulted in the development of an integrated suite of EHR-centric tools to enable trial design, feasibility and data management to CDISC-ODM standard EDC interfaces, enabling recruitment, minimum data collection, and patient reported outcomes (PROs). The resulting technology platform has benefits in terms of speed, costs and generation of real-world evidence.
12:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:00 Dessert Break in the Exhibit Hall
1:30 Close of Conference