Global Site Selection, Feasibility Assessment, Operations and Site Management
Data-driven global site selection, an optimized feasibility assessment process, and effective site management are critical to improving clinical trial timelines and outcomes. Too often companies fail to learn from past mistakes and take the same approach to protocol development, trial planning and program execution. In order to overcome challenges in clinical trial planning, operations and site management leaders should learn from the best practices of their peers, utilize data and technology to support decision making, and improve communication and relationships between Sites, CROs, and Sponsors. Cambridge Healthtech Institute’s Sixth Annual “Global Site Selection, Feasibility Assessment, Operations and Site Management” conference will cover the topics one should consider when planning and implementing a trial.
Monday, February 22
7:00 – 9:00 pm Welcome and Networking Happy Hour on the Riverwalk hosted by CHI, DrugDev and Praxis
Tuesday, February 23
7:15 am Registration and Morning Coffee
8:25 Opening Plenary Keynotes - View Details
9:45 Grand Opening Coffee Break in the Exhibit Hall
10:45 Chairperson’s Remarks
Jackie Kent, Senior Director, Clinical Development Information & Optimization, Eli Lilly and Company
10:50 Tying Product Strategy to Trials: Looking More Strategically at Why and How We Go to Certain Places for Trials
Kelly McKee, Recruitment, Retention and Innovation Team Lead, Global Trial Optimization, Merck & Co., Inc.
Mark Travers, Ph.D., MBA, Global Head, Monitoring Excellence & Interim Head of NA Region Global Clinical Trial Operations, Merck & Co., Inc.
Global trials require us to think broadly while also executing as quickly as possible. We look at countries and patient populations, we select sites and launch trials, we build relationships with our partners, CROs, site, PIs and ideally with the patients themselves. We have all of this process broken down by cost, time and key milestones. However, we sometimes skip some of the earlier strategic considerations that can help both our trial run smoothly and improve the likelihood of commercial success for the product.
11:15 CO-PRESENTATION: Designing a New Clinical Research Ecosystem around the Most Important Human – The Patient
Katherine Vandebelt, Senior Director, Clinical Innovation, Eli Lilly and Company
Jackie Kent, Senior Director, Clinical Development Information & Optimization, Eli Lilly and Company
You need to have a physician to care for the patient and then you must add the necessary integrated infrastructure for these two humans to make the trial experience feasible, responsive and considerate. Doing this will enable us to get clinical answers faster. We are currently experimenting with changing the time and place of clinical research to increase the feasibility of conducting research. We need to prove that data quality is maintained and burden for the doctor is reduced such that they can maintain oversight and perform their investigator duties.
11:40 Operational and Strategic Approaches in Conducting Clinical Trial Feasibility
Susie Campos, Associate Director, Clinical Trial Intelligence, Global Clinical Trial Leadership, Novartis Pharmaceuticals
In this session, current approaches in conducting trial feasibility will be discussed with emphasis on the strategic approach needed to successfully operationalize the process. With a variety of study types and needs, approaches for feasibility need to be flexible yet still yield robust results. With the increase in number of trials conducted, improved feasibility methodology is needed to ensure the process is efficient and data obtained is high quality. The Learning Objectives are: 1) define types of trial feasibility 2) outline feasibility methodology currently used 3) benefits of operational and strategic approaches 4) future possibilities.
12:05 pm Are Your Investigators Championing Your Study within the Medical Community? A Strategic Look at Maximizing Referring Physician Contributions
Bonnie Brescia, Founding Principal, BBK Worldwide
As the clinical trial landscape becomes more competitive, those studies that have strategic communication plans to engage and motivate referring physicians will have a distinct edge. Learn about BBK’s research initiative, including responses from specialists in over 30 countries, revealing the group’s attitudes and practice regarding matching their patients with clinical trial options – along with practical information about what clinical teams can do to maximize the likelihood that they will refer patients to your studies.
12:35 Luncheon Presentation: Building a Strategic Site Network to Optimize Your Clinical Trial
Kimberly Ray, Vice President, Site & Patient Networks, Quintiles
Understand the value of forming a strategic site network in clinical research to optimize clinical trials from site advocacy to sharing critical information, including setting and measuring metrics to assess the ROI to build peak network performance and leveraging these relationships for innovation. Hear methods to build the relationship using transparency and innovative communication methods.
1:20 Coffee and Dessert in the Exhibit Hall
2:00 Chairperson’s Remarks
Susie Campos, Associate Director, Clinical Trial Intelligence, Global Clinical Trial Leadership, Novartis Pharmaceuticals
2:05 Country Feasibility: Data-Driven Methodologies
Michelle Everill-Flinders, Director, Feasibility Center of Excellence, Pfizer
Country selection tends to go through methodological changes every couple of years. Country-level data can be a challenge to collate and address. What approaches are being taken across CROs and Pharma to increase local intelligence and application to clinical trials? Trends in emerging markets are showing that added investment is required for trial success. Pfizer has a premier site relationship program to further develop sites in emerging markets and have shown quality, enrollment, and start up success. This talk will share an overview of key items to consider in country feasibility, regional differences, and risk mitigation planning.
2:30 CO-PRESENTATION: Predicting Success of an Unknown Site: The Science of Quantifying Performance Opportunity of New Sites
April Lewis, Head, Clinical Trial Optimization Solutions, IMS Health
Bettyna Jones, Senior Process Excellence Leader; Business Process Owner Close Out; Business Lead Site Productivity, Roche
Lucas Glass, Data Sciences, Clinical Trial Optimization Solutions, IMS Health
For those sites with whom a Sponsor or CRO has experience, past performance can be a critical predictor of future performance. But how is site performance potential evaluated on new sites where this information does not exist? This presentation will provide details on a comprehensive analysis performed utilizing site level recruitment patterns, detailed site demographics, and site level claims data to determine the factors that predict site performance in the absence of history or experience.
2:55 INTERACTIVE PANEL: Generating Success of an Unknown Site: The Art of Supporting New Sites in Achievement of Performance Greatness
Richard Mayewski, Associate Director, Clinical Trial Intelligence, Novartis
April Lewis, Head, Clinical Trial Optimization Solutions, IMS Health
E.B. McLindon, Vice President SMO Affairs, Clinical Research Service, ICON
Panelists will hold an open discussion on the trends their organizations are experiencing in the use of new sites, and how both process and relationship management is modified to ensure successful outcomes for both Sponsor and Site. The panel organizations do utilize new sites as a standard practice – but are the outcomes from these sites worth the investment?
3:20 Advanced Feasibility Modelling
David Cocker, CSO, ta-Scan, MDCPartners
Feasibility is the leading contributing factor for missed timelines and budget overruns. Feasibility basically is a confidence prediction of your downstream research network. Patient recruitment simulation software is plugging many information gaps in the feasibility departments. This presentation highlights new data sources, algorithms and visualizations to shore up your feasibility assessments.
3:35 Partners in the Study Enterprise: Sponsor, CRO and Large Site Networks
Vicki Duvall, RN, BSN, Trevi Therapeutics, Inc
Brigid Flanagan, Senior Director, Clinical Development, Frenova Renal Research
Selecting the right partners at the beginning of a study has proven to be a success for this specialty CRO and sponsor. At the outset, the sponsor invited the CRO and the respective site networks to the kick off meeting; a novel approach. Both representative teams provided input on challenges with this study population. Having key stake holders at study start improves study success by increasing high quality data, on time deliverables, and staying within study budgets.
3:55 Find Your Table and Meet Your Moderator
4:00 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.
Complete list of Breakout Discussion Groups
5:00 Welcome Reception in the Exhibit Hall
6:30 Close of Day
Wednesday, February 24
7:15 am Registration
7:45 Breakfast Presentation: Operational Excellence in Real-World Research: Observational Studies & Registries
Radha Puri, Associate Director, Americas, Real-World Evidence Strategy Unit, Real-World Late Phase Research, Quintiles
Obtaining and maintaining operational excellence in real-world research requires connecting insights for better outcomes. Understand the challenges to mitigating risks while maximizing data quality and hear how to achieve and maintain quality standards in observational studies and registries while minimizing site burdens.
8:25 Chairperson’s Remarks
Maria Cipicchio, Strategic Consultation, BBK Worldwide
8:30 Trial & Error vs. Evidence-Based Site Selection
Jorge Guerra, M.D., Executive Director, J.G. Guerra ClinOps Management; former Senior Vice President Global Clinical Operations, Biogen Idec
The selection of high quality investigative sites is a key success factor in the execution of clinical trials. According to the Tufts CSDD, 11% of sites fail to enroll a single patient and 37% underenroll. Similar to any other major investment project, Sponsors / CROs should apply systematic due diligence to site selection. The speaker will review the most critical aspects of this process and provide practical examples, with emphasis on the availability of the study population.
8:55 CASE STUDY: Selecting Sites for a Large US Abbott Nutrition Study Recruiting from Hospitals
Sonja Acosta, Project Lead / Senior CRA, Scientific & Medical Affairs, Abbott Nutrition
This presentation will focus on lessons learned from a 3 year nutritional study involving over 100 sites selected from the US. Originally this study was intended to involve 40 sites. However, through many site and recruitment challenges, nearly 120 sites were initiated for this large nutritional study in order to meet enrollment. This presentation will focus on aspects to consider when selecting sites who are recruiting from a hospital setting. Sponsors will learn how to find the appropriate sites for studies. Sites will learn the foundation they need internally to be a successful site recruiting from an in-patient hospital setting.
9:20 CO-PRESENTATION: Innovative Approaches to Decreasing Burdens Placed on Investigator Sites
Jackie Kent, Senior Director, Clinical Development Information & Optimization, Eli Lilly
Jennifer Burgess, Senior Director, Communications & Engagement, TransCelerate
This session will provide an overview of some of the key challenges investigators face in working with sponsors, and what solutions TransCelerate has undertaken to affect change. The session will focus on efforts to reduce administrative burdens with Site Qualification & Training, and the Shared Investigator Platform. A discussion of key lessons and strategies for trial leaders from the sponsor, investigator, site and CRO communites will follow.
9:45 Integrating Multiple Data Sources to Optimize Site Selection
Karen Currie, Executive Director, Citeline/Informa
Susan Hamilton, Research Analyst, Clinical Development Information and Optimization, Eli Lilly and Company
This presentation will demonstrate how to leverage multiple sources in order to identify top investigators in locations with large patient pools and minimal ongoing trial activity. Optimizing site selection through these methods will aid the demands of timely patient enrollment in clinical trials.
10:10 Coffee Break in the Exhibit Hall
11:10 Chairperson’s Remarks
11:15 Maximizing Use of Claims and EHR Information During Clinical Development to Improve Diversity in Trials, from Protocol to Enrollment
Devin Trejo, MBA, Director, Oncology Feasibility Lead, Development Operations, Feasibility Center of Excellence, Pfizer
There’s a gap in communicating to patients the value-availability of trials. The goal to improve recruitment-retention from diverse demographic, cultural and socio-economic backgrounds benefits patients as well as improves meaningful scientific endpoints. Identifying patients, barriers to participation inclusive of orphan/rare disease, diverse ethnic populations, age, gender and integrating the patient perspective will help better address current clin ops challenges. To address these challenges we have taken a holistic approach from protocol development through patient engagement in order to improve enrollment across diverse patient populations.
11:40 CO-PRESENTATION: Generate Trial Intelligence Insight through Internal and External Trial Information to Accelerate Trial Feasibility
Jill Loftiss, Senior Director, Oncology, Clinical Ops Head, AZ/MedImmune
Jane Fang, M.D., Director, R&D IS Lead, Clinical Business Management & Analytics, AstraZeneca/MedImmune
Conducting evidence-based trial feasibility through advanced analytics is an essential investment to ensure robust clinical program and study planning in today’s highly competitive environment of drug development. This talk is to present a use case of building trial feasibility informatics capability for immune-oncology programs to conduct integrated analysis to generate insight by leveraging key trial information sources and an intelligence portal to visualize competition landscape of internal and external trials and usage of countries, sites and PIs across globe.
12:10 pm Bridging Luncheon Presentation: Real World Data in Clinical Trial Planning: Game Changer?
Bernadette Collins, Senior Manager, Data Services, Clinical Trial Optimization Solutions, IMS Health
April Lewis, Head, Clinical Trial Optimization Solutions, IMS Health
IMS Health is the world’s largest purveyor of healthcare data. Over the past few years, we have developed a team of experts dedicated to evaluating the most influential assets to support trial feasibility and increased success in site selection and trial planning. In this session our experts will review what type of global assets are obtainable, how these assets can validate and substantiate trial planning decisions. Practical examples will be shared and case studies will be reviewed.
12:50 Coffee and Dessert in the Exhibit Hall
1:30 Close of Conference