Cambridge Healthtech Institute’s Third Annual

Patient Recruitment & Site Selection

Ensuring Study Start-Up Success with Patient-Centric Approaches to Patient Recruitment and Site Selection

May 7-8, 2018 | Aloft Boston Seaport | Boston, MA

Successful study start-up hinges on meeting patient recruitment goals and selecting and engaging with clinical trial sites and investigators that can effectively launch study start-up activities. Cambridge Healthtech Institute’s “Patient Recruitment & Site Selection” conference features best practices and case studies on successful patient engagement, recruitment and site selection techniques using novel, patient-centric and data-driven approaches.

Final Agenda

Monday, May 7

7:25 am Conference Registration and Morning Coffee

PATIENT RECRUITMENT FROM A RESOURCE LIMITED PERSPECTIVE

8:25 Chairperson’s Opening Remarks

Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC

8:30 Insights from a Large Healthcare System: Solutions to Barriers to Patient Recruitment in Digital Health Research

Ramya PalachollaRamya Palacholla, MD, MPH, Scientist, Partners Healthcare Connected Health Innovation, Harvard Medical School, Massachusetts General Hospital

This talk, based on the available literature and extensive digital health research experience of the speaker in one of the largest healthcare systems in the country, will attempt to discuss the importance of recruitment of research participants, the associated barriers and challenges, and various strategies to overcome these barriers.

9:00 PANEL DISCUSSION: Patient Recruitment Strategies for Resource Limited Pharma/Biotech

Jzaneen_LalaniModerator: Jzaneen Lalani, COO, Curemark


Panelists: 

Lori Ann Correia, Director, Clinical Operations & Patient Advocacy, Inozyme Pharma

Dawn Harper, Executive Director, Clinical Operations, Strongbridge Biopharma

Kim Kaiser, Principal, Kim Kaiser and Associates, LLC representing LUPUS RESEARCH ALLIANCE

Rose_GerberRose Gerber, Director, Patient Advocacy and Education, Community Oncology Alliance (COA)

Launching a clinical trial hinges on successful patient recruitment. However, this often-difficult task is made even tougher by limited resources and finances. This panel will bring together stakeholders from patient advocacy, sponsors, and sites to discuss innovative approaches and successful case studies which resource limited pharma/biotech can apply to their patient recruitment efforts.

10:00 Networking Coffee Break

RETHINKING PATIENT ENGAGEMENT & THE SITE EXPERIENCE

10:30 Informed Consent Optimization Project Using Patient Voice and Technology

Cassandra SmithCassandra Smith, Associate Director, Investigator and Patient Engagement Projects, Global Clinical Development Operations, Janssen R&D

Informed Consent is one of the most important aspects of the clinical research process; it is also one of the areas that most Sponsor companies struggle with, as the document is heavily regulated by the regulations and internal compliance/legal groups. Janssen R&D is undergoing a project to overhaul the ICF document and delivery process to make it more effective and patient-centric.

11:00 Enhancing Recruitment and Retention: Best Practices and Resources for Engaging Patients and Study Teams

Kristin Demafeliz, Senior Associate Director, Research Partnerships, Michael J. Fox Foundation for Parkinson's Research

No amount of money can replace study volunteers. By addressing challenges in two key audiences, study teams and study participants, recruitment of research participants can be enhanced holistically. A presentation on educating and connecting the Parkinson’s community with studies that need them and sharing recruitment and retention best practices with the field.

11:15 E-Source: Why the Slow Adoption by Research Sites?

Chris_HoyleChris Hoyle, MBA, Executive Director, Elite Research Network

For both sponsors and sites, e-source provides many advantages including cost savings and cleaner, quality data. So why are sites still reluctant to move from paper to electronic source? During this session a site perspective will be shared as to why the hesitation to transition away from paper and how industry can work together to expedite the adoption of e-source.

FIRMA Clinical Research 11:30 How Do I Create a Patient Centric Protocol and Clinical Trial?

Michael_KeensMichael Keens, MS, COO, Firma Clinical

The clinical trial industry has been undertaking a renewed effort on patient focus within protocols, known as “Patient Centricity.” This approach can involve direct patient input on protocols, fewer office visits using home health care and data collection efforts using wearable technology. We’ll review case studies and direct patient feedback on the use of home health care visits within trials, considerations when implementing, and examples of benefits and patient perspectives.

IQVIA_CTOS12:00 pm Luncheon Presentation: Filling the Gaps in Site Selection: What You Don’t Know Can Help You

April Lewis, MS, Director, Offerings and Marketing, IQVIA CTOS

Karen Currie, Executive Director, Editorial Citeline, Informa Pharma Intelligence

Industry statistics show that we continue to rely on the same investigators over and over, regardless of prior performance. This leads to investigator exhaustion, timeline extension and lost opportunity. This co-presentation from IQVIA CTOS and Informa Pharma Intelligence’s Citeline, will highlight a collaboration aimed at delivering a unique combination of data, technology and analytics to optimize the site feasibility process. This joint effort offers ‘one-stop site shopping’ within placement areas ripe for recruitment success.

12:45 Session Break

RETHINKING PATIENT ENGAGEMENT & THE SITE EXPERIENCE (Cont.)

1:25 Chairperson’s Opening Remarks

Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC

1:30 Understanding the Patient Voice to Achieve the Clinical Trial Registry of the Future and Revolutionize Trial Information Exchange

Christine_CrandallChristine Crandall, Head, Strategic Clinical Planning, GlaxoSmithKline

With growing calls for transparency of clinical trial information in various countries and increasing recognition of its value, an unfortunate side effect has become a difficult-to-navigate landscape of data and information. TransCelerate has undertaken an initiative to publish a proposal and wireframe mock-up illustrating patient-focused improvements for adoption by government registries. This initiative believes that understanding the situation patients (or caregivers) might find themselves in when visiting a clinical trial registry lends valuable context to their expectations of user experience. Furthermore, patients often lack useful information about a clinical trial before, during, and after their participation; meanwhile, costly and slow recruitment coupled with sub-optimal retention is delaying the delivery of new treatments. This session will discuss a series of post-trial communications templates that the TransCelerate Information Exchange initiative has developed to bridge this gap, and ultimately improve patients’ satisfaction with their clinical trials.

2:00 Redefining the Site Investigator Experience

Krupa Patel, Director, Business Enablement Organization, Merck

Imagine a world where site investigators could use a centralized point of access for all study related tasks and study information, rather than many portals and platforms, to access studies with every sponsor they work with. Imagine if sponsors could quickly search for and download their latest study documents, and easily access a registry of investigator profiles to assess feasibility for new studies. The Shared Investigator Platform (SIP) was launched with these goals in mind, and continues to evolve with new functionality as it is adopted by additional TransCelerate member companies and their associated investigator sites. The SIP was developed with sites, for sites, to enable greater collaboration with participating sponsors, and make room for higher value activities, like trial execution and spending time with patients.

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

5:30 Close of Day

5:30 Dinner Short Course Registration

Tuesday, May 8

7:25 am Morning Coffee

BIG DATA ANALYTICS FOR PATIENT RECRUITMENT & SITE FEASIBILITY

7:55 Chairperson’s Opening Remarks

Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC

8:00 CO-PRESENTATION: Innovative Clinical Trial Recruitment Strategy Enabled by Smart Data Analytics: Go Where the Patient Are

Aniket_JoshiAniket Joshi, Associate Director, R&D Innovation, Otsuka Pharmaceutical


Saloni BehlSaloni Behl, Associate Director, Commercial Planning, Otsuka Pharmaceutical


Almost two-thirds of clinical sites do not meet patient recruitment targets in clinical trials, as per the 2011 Tufts report. There have been a number of approaches explored to boost clinical trial recruitment with some mixed success. While there are tools with promising visuals by leveraging big data analytics, most tools do not provide any actionable insight for study teams to implement in areas “where the patients are”. An example of leveraging smart data analytics combining real world data, internal clinical operations data and publicly available resources will be discussed that supported development of a novel and actionable targeted recruitment approach.

8:30 Bridging the Gap between Data Analytics and Patient Recruitment

Angelique HopkinsAngelique Hopkins, MPH, Associate Director, Clinical Trial Analytics, Business Insights & Analytics, Bristol-Myers Squibb


9:00 Attention to Real World Data Opportunities in Clinical Development

Gurparkash SinghGurparkash Singh, Manager, Electronic Health Records (EHRs), Janssen R&D

Execution of global clinical trials is a complex, costly, and time-consuming endeavor with operational challenges regarding study design, site selection, screening and enrollment that often result in costly amendments. Real world data (RWD) has the potential to mitigate some of these challenges. We will share our experiences towards finding ways to leverage RWD for clinical trial operation efficiencies. We will also share work of some IT solution providers in this domain.

RTI International  9:30 Leveraging Communication Science to Improve Informed Consent

Lauren_McCormackLauren McCormack, PhD, Vice President, Public Health Research Division, RTI International

Informed consent is often a confusing and challenging process for participants and can be a barrier to patient recruitment, engagement, and successful trial completion. But it doesn’t have to be. Learn how communication science can enhance the consent process, improve patient understanding, and increase participant enrollment and patient engagement.

10:00 Coffee Break in the Exhibit Hall


10:45 PLENARY KEYNOTE SESSION

Transformation through Digital Medicine: The Time is Now!!

Ashish Atreja, MD, MPH, FACP, Chief Technology Innovation and Engagement Officer, Medicine, Icahn School of Medicine at Mount Sinai

Value based healthcare and outcome based contracts are reshaping the entire health industry and major players including health systems, payers and pharma. Digital Medicine is an emerging discipline that can enable transformation of health systems to support both patient centered clinical care and research. Dr. Atreja, will provide an overview of current state of the art of digital medicine, review the challenges faced in digital medicine adoption and demonstrate how prescription of digital medicine can support care and research transformation.

As Chief Technology Innovation and Engagement Officer, Medicine, Dr. Atreja leads the Sinai AppLab (www.sinaiapplab.org), a one-of-a-kind collaborative hub to build and test disruptive mhealth technologies. Dr. Atreja leads scientific registries for the American Gastroenterology Association and serves on the Innovation Advisory Board for American College of Cardiology. As an intrapreneur, Dr. Atreja has won innovation awards at Cleveland Clinic and Mount Sinai, successfully licensed technologies from academic centers and advises startups, accelerators and Fortune 500 companies in digital medicine. More recently, Dr. Atreja launched the first enterprisewide app curation and prescribing platform (www.rxuniverse.com) and established Network of Digital Medicine (www.nodehealth.org) to connect innovation centers worldwide and share best practices for digital medicine innovation and implementation.

11:50 Walking Lunch & Dessert Break in the Exhibit Hall

1:20 Close of Conference


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From the Producers of:

From the Producers of SCOPE