Enrollment Planning and Patient Recruitment
Patient recruitment and up-front enrollment planning are critical to drug development programs. Patient recruitment if not adequately planned for can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for your analysis and subsequent filings. In order to optimize both you have to have a plan. Cambridge Healthtech Institute’s Ninth Annual “Enrollment Planning and Patient Recruitment” conference will cover the topics one should consider when drafting and strategically implementing a patient recruitment plan for a clinical development program.
Stay on and attend Part 2: Engagement and Retention
Day 1 | Day 2 | Keynotes | Monday Short Courses | Speaker Biographies
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
Stewart Rosen, M.D., Vice President, Medical Affairs, Health Management Solutions, Quintiles
10:50 Leveraging EHR Data for Patient Recruitment: Don’t Ask, Tell! (An Updated Case Study)
Tim McGarty, Global Director, Clinical Innovative Services, Novartis
The days of asking Investigators how many patients they have in an indication may soon be over. By leveraging EHR data, one can identify qualified patients that match a majority of your protocol’s I/E criteria. The list of patients derived from the data interrogation can now be placed in the hands of the Investigator, who in turn may invite their patients in for consideration in a study. This session will give an update on an ongoing pilot where patients are identified through data mining and recruited, provide preliminary metrics, and to convey what is going well, and where there are opportunities for improvement.
11:15 Innovative Predictive Model for Subject Recruitment Risk in Clinical Trials
Mohanish Anand, Ph.D., Senior Director and Head, Feasibility Center of Excellence, Development Operations, Pfizer
One of the most significant challenges to clinical trial success is the early identification of subject recruitment risk. While progress against agreed to recruitment milestones is the traditional measure of subject recruitment success there is a need for measure to surface future recruitment risk. We have developed a comprehensive methodology incorporating a study’s current state of recruitment performance with predictive algorithms to evaluate future outcomes. The predictive algorithms add elements of potential site exhaustion and subsequent subject recruitment slow down to traditional measures to provide insights to future outcomes.
11:40 CO-PRESENTATION: Enabling Strategic and Data Driven Management of Early Development Studies
Timothy Hagerty, Ph.D., Senior Clinical Program Leader, Genentech Research and Early Development Clinical Operations, Genentech
Jennifer Bell, Analytics Lead, Clinical Operations, Genentech
Recently we’ve shifted to a more data driven focus for study planning and management. Foundationally, this was dependent on defining the architecture and quality assessment of an integrated data warehouse. The EMMA (Enrollment Management and Measurement Application) tool was built on this platform to help teams have leading and lagging indicators on the status of the study in a visually compelling manner. This tool covers the diversity of early development studies down to a patient level view and expands to focus on the drivers at a site and country level perspective aligned to our company’s deliverables. This has allowed a level of accuracy and transparency across many functional groups within clinical development, allowing us to be more agile in our decisions and more strategic in our focus
12:05 pm Presentation to be Announced
12:35 Luncheon Presentation to be Announced
1:20 Coffee and Dessert in the Exhibit Hall
2:00 Chairperson’s Remarks
Bonnie Feldman, M.D., “All Things Autoimmune” Entrepreneur, DrBonnie 360
2:05 Multiculturalism and Your Trials: 3 Reasons to Care and 3 Ways to Rethink Implementation
Lisa Valtierra, Associate Director, Patient Advocacy Relations & Cross Cultural Marketing, Boehringer Ingelheim
Clinical trials have historically and consistently had abysmally low recruitment and retention rates of minorities. Why does it matter? What’s culture got to do with it? How can we change this? In this presentation, we will discuss approaches to engaging, enrolling and retaining trial participants. The audience will better understand how demographic shifts in the US population reveal a disproportionate prevalence of certain diseases affecting minorities and how understanding cultural differences among communities regarding health and health behavior can- and should- change the way sponsoring companies choose investigators, trial sites, and methods of recruitment.
2:30 Understanding and Implementing the New Reality of Diversity in Clinical Trials
Karen Machelle Brooks, Senior Director, Clinical Operations Therapeutic Area Group Lead, Oncology, Development Operations, Pfizer
Understand regulatory changes from FDA and updated requirements for ethnicity/race inclusion in trial populations. How do you formalize into a clinical development plan at a company level to make it part of corporate culture by educating and training teams so that they can embrace the ethnicity value? How do you then implement at project team level and operationalize the activities to support diversity in clinical trials?
2:55 CASE STUDY: Operationalizing Diversity Initiatives in Clinical Research
Marisa Rackley, Director, Clinical Research, Global Trial Optimization, Merck
The industry understands that diversity in clinical trial participation is important. Translating those values into operational plans for particular trials has been a challenge. Building a framework for teams is critical in order to realize installation of these corporate initiatives. Real world examples and case studies will provide background for the talk.
3:20 Turn Around Slow-Enrolling Trials
Melynda Geurts, Vice President, Operations, DAC Patient Recruitment Services
Slow enrolling trials can cost valuable time and money. This presentation will help you avoid or turn around a slow-enrolling trial. We’ll show you how to create a plan of attack, how to set reasonable enrollment expectations, tips for getting management buy-in, how to energize sites and other stakeholders, and execution and performance tracking measures to help you turn around or avoid slow enrolling trials.
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.
5:00 Welcome Reception in the Exhibit Hall
6:30 Close of Day
Day 1 | Day 2
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
Mark Summers, President & CEO, ThreeWire, Inc.
8:30 A Year in Review CASE STUDY: Evolving and Validating a Patient Recruitment Department
Diane Montross, Director, Patient Recruitment & Engagement, Shire Pharmaceuticals
Is a patient recruitment department a valuable entity for a mid-sized pharma company and how do you demonstrate value to broader clin ops enterprise? Diane will talk candidly about her first year leading the Patient Recruitment & Engagement team at Shire. She’ll share her experience in growing the department to support the full development pipeline. Case study examples will include: changing the clinical teams’ mindset around recruitment, incorporating recruitment into study start-up process, working with and leveraging internal depts/resources and external vendor partners to effectively expedite enrollment timelines, and proving the value of patient recruitment support for clinical studies to management.
8:55 The Power of Social Media and Content Marketing
Joseph Kim, MBA, Senior Advisor, Clinical Innovation, Eli Lilly and Company
Making use of social media isn’t just about engaging in two way dialogue. It’s also about creating content that’s worth sharing. Come learn about Lilly’s foray into a world of using stories to educate and inspire action in clinical research, through the industry’s first bona fide documentary on clinical research participants.
9:20 Partnering for Success: Elements of a Healthy Sponsor/Vendor Relationship in Patient Recruitment
Katherine (Katie) Norton, Associate Director, PRE Lead, Patient Recruitment and Engagement, Shire Pharmaceuticals
Most of us spend a significant amount of time either managing patient recruitment vendors or providing patient recruitment vendor services to sponsors…but do we do it well? This presentation looks at the elements of a successful sponsor/vendor collaboration from both the sponsor and vendor perspectives. We’ll examine best practices for the RFP and contracting process, start-up and in-study communication, conflict resolution, and project closeout. We’ll identify common pain points in sponsor/vendor partnerships and provide recommendations for alleviating these issues for optimal outcomes.
9:45 CASE STUDY: Supporting Sites is the Key to Patient Recruitment Success
Gretchen Goller, Senior Director, Patient Access and Retention Services (PARS), PRA International
The session will review the different models of site support that being utilized in clinical trials today and define the importance in which these type of supports are crucial to maximize productivity with study sites. It will also provide a case study where various elements of site support was implemented and the outcome of those efforts.
10:10 Coffee Break in the Exhibit Hall
11:10 Chairperson’s Remarks
Aaron Fleishman, Technology and Product Innovation, BBK Worldwide
11:15 Narrowing Enrollment in Trial Planning
Michelle Everill-Flinders, Director, Feasibility Center of Excellence, Pfizer
Narrowed and more targeted patient populations are creating increased need for innovative trial planning methodology. Data mining can drive directional decision making, but how can we ensure these patients have access to trials that are directed at their specific condition? The Novartis Signature trial and NCI MATCH program are two ways in which we, as sponsors, CROs, sites, site networks, and IRBs, have brought trials to patients.
11:40 CASE STUDY: Exploring Progression from an Undeveloped Process to Advanced Enrollment Modeling to Support Forecasting of Proof-of-Concept (PoC) Trials
Sameer Tandon, Clinical Trial Intelligence Manager, CS&I, Novartis Pharmaceuticals Corporation
This presentation will showcase a case study describing the evolution of enrollment planning and forecasting. The audience will appreciate the challenges of forecasting and benchmarking and how advanced tools and techniques have aided in the support of better plans.
12:10 pm Bridging Luncheon Presentation: Harnessing Real-Time Data to Optimize Site and Patient Recruitment
Meghan Winegrad, Managing Director, New Solutions, UBC: An Express Scripts Company, The Lab - Express Scripts Technology and Innovation Center
When it comes to use of data for clinical trial optimization, are all data sets created equal? This presentation will illustrate how data-driven insights from more than 130 million patients can fuel smarter, more efficient solutions for patient and site recruitment. Using case studies, the presentation will demonstrate how pharmacy and prescription data can be utilized to inform protocol design, identify study sites with strong enrollment potential, and directly reach qualified patients for a given study.
12:50 Coffee and Dessert in the Exhibit Hall
1:30 Close of Conference
Stay on and attend Part 2: Engagement and Retention
Day 1 | Day 2 | Keynotes | Monday Short Courses | Speaker Biographies