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Patient Engagement, Enrollment and Retention through Tech, Disease Communities and Advocacy Groups


Enrollment planning and patient recruitment are critical to drug development programs and garner a lot of attention by study teams. However, once the hard work of identifying and recruiting a trial subject has been accomplished they must be retained and remain in compliance. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for your analysis and subsequent filings. There are strategies, tools and techniques such as social media platforms and mobile technology, empowered patient communities, and a more informed patient population that need to be understood and engaged. Cambridge Healthtech Institute’s Third Annual “Patient Engagement, Enrollment and Retention through Tech, Disease Communities and Advocacy Groups” conference will cover the topics one should consider when planning and strategically implementing a patient retention plan in the digital age.

Wednesday, February 24

12:10 pm Bridging Luncheon Presentation: Harnessing Real-Time Data to Optimize Site and Patient Recruitment

Winegrad_MeghanMeghan 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.

Alpha Clinical Systems12:50 Coffee and Dessert in the Exhibit Hall

 

1:30 Plenary Keynotes - View Details

Alpha Clinical Systems3:00 Refreshment Break in the Exhibit Hall (Last Chance for Viewing)

 


LEVERAGING INSIGHTS FROM STUDY PARTICIPANTS AND CLINICAL SITE STAFF IN TRIAL DESIGN AND EXECUTION

4:00 Chairperson’s Remarks

Jennifer_KellyJennifer Kelly, Director of Operations, HealthiVibe, LLC


4:05 Championing the Voice of the Customer in Research: Leverage Insights from Study Participants and Clinical Site Staff in Trial Design and Execution

Collins_MichelleMichelle Collins, Ph.D., Director, Clinical Program Development, AbbVie

Clinical trials often struggle with patient recruitment & retention, and maintaining site engagement through the duration of the trial. This presentation will explore opportunities to improve these trial challenges through effective implementation of key customer insights, in particular those of the study participants and clinical site staff. This talk will identify new opportunities to gain impactful insights from study participants;,ways to effectively leverage those insights in the trial design and execution, and explore examples of successful implementation.

4:30 What’s Inn- and Out-ovative in Patient Recruitment

Fleishman_AaronAaron Fleishman, Technology and Product Innovation, BBK Worldwide

It may be hard to believe but Facebook is already over ten years old! In fact, you could argue that Facebook is no longer considered “cool.” When it comes to clinical trial awareness and engagement, what’s the new cool? How does it work in sync with the old? In this presentation we will travel back in time to the birth of social media, the rise of digital media, and a look at what’s coming next.

4:55 “Patient Centricity”... Now What? Real-World Examples of Patient Centric Strategies to Optimize Enrollment

Skubiak_TayaTaisa Skubiak, Associate Director, Enrollment Optimization, Clinical Trial Planning & Operations, Bristol-Myers Squibb

Patient centricity has been a popular topic in clinical trials, though we don’t hear much about how this has been practically applied. As sponsors navigate this space, some strategies are emerging that may help to communicate with and find patients for studies. This talk will share real-world examples of how a biopharma is applying patient centric concepts to patient recruitment.

5:20 INTERACTIVE PANEL: Faces in the Crowd: Why We Do What We Do

Kasher_JeffJeffrey Kasher, Ph.D., President, Patients Can’t Wait


Kleger_BrettBrett Kleger, Chief Commercial Officer, DrugDev


Pacino_AlAl O. Pacino II, President, HealthCarePoint


Jennifer_KellyJennifer Kelly, Director of Operations, HealthiVibe, LLC


The concept of the “Abstract Patient” has become too common in our industry, especially at conferences where we gather to discuss ideas and debate the best ways to support them. While we hold the patient in high regard, we fail to realize as a collective that patients are not an abstract third-party, but rather our parents, spouses, friends, children and selves. As an industry we are not yet patient centric in our planning and operations. Why not and how can we get there? The goal of this session is to pull out the familiar faces from the crowd and learn the stories that drive them to do what they do.

5:45 Close of Day


Thursday, February 25

7:15 am Registration

7:45 Breakfast Presentation: How One (Golden) Number Can Transform Clinical Trials

Elisa Cascade, MBA, President, Data Solutions, DrugDev

For years pharmaceutical companies and CROs have struggled to collect, clean and collate site data from disparate sources so they can make better decisions about site feasibility and selection. With the DrugDev Golden Number - a universal identifier for Investigators and sites - individual pharma companies and CROs easily match and master data, and share data across collaborations like the Investigator Databank and TransCelerate. While the Golden Number began as a method for data sharing, innovators are using it to drive operational efficiencies, collaboration and integrated reporting as well. We expect it also will give regulators a more detailed view into the global investigator community, which ultimately can improve patient safety. Join this session for a discussion on the Golden Number and how it can help pharma, CROs and sites do more trials.



DESIGNING AND IMPLEMENTING A PATIENT-CENTRIC TRIAL: SOCIAL LISTENING, ACCESS, INNOVATION

8:35 Chairperson’s Remarks

Peacock_EricEric Peacock, CEO, myHealthTeams


8:40 CO-PRESENTATION: Social Media in Clinical Trials – If We Listen, What Will We Hear?

Matczak_JerryJerry Matczak, Community Manager, Clinical Open Innovation, Eli Lilly and Company


Ivsin_PaulPaul Ivsin, Director, Offerings Development, Clinical Trial Optimization Solutions, IMS Health


Patient engagement is high on many priority lists, but few clinical development teams have actively worked through the challenges, and even fewer best practices exist. This talk will share lessons learned during our launch into Social Listening in Clinical Trials. There are a lot of challenges and insecurities in choosing to use social media listening in the clinical trial space and this session will review how Lilly overcame internal challenges to drive innovative use of social media in the clinical realm, the lessons that were learned and the things we would do better next time.

9:05 Leveraging the Patient’s Voice through Stakeholder Engagement

Immo ZadezenskyImmo Zadezensky, PharmD, Ph.D., Clinical Pharmacologist, Professional Affairs and Stakeholder Engagement (PASE), Office of the Center Director, CDER, FDA

The current paradigm of patient involvement in protocol and drug development is shifting towards more systematic inclusion of patient preferences and patient centric endpoints at all stages. How can we leverage this valuable information on risk-benefit assessment in a complex, multi stakeholder drug development environment? This presentation will explore past and current stakeholder engagement efforts, as well as evaluate ideas to enhance and broaden meaningful inclusion of patients’ voice in risk-benefit discussions.

9:30 CO-PRESENTATION: Operational Approaches to Speed Progress on Patient-Centered Clinical Trials

Lipset_CraigCraig Lipset, Head, Clinical Innovation, Pfizer

Jennifer Burgess, Senior Director, Communications & Engagement, TransCelerate BioPharma, Inc.

The industry is headed more and more towards a patient-centered model. Patient centric clinical trials are no exception. This session will focus on key things that can be done to create a better informed patient and better run clinical trials, ultimately with the hope to increase a patient’s engagement and satisfaction participating in a clinical trial. This talk will offer an understanding of key challenges with patient centricity in trials, and an overview of what this unique collaboration of 20+ sponsors is doing to address with initiatives in eConsent, patients and trials and other efforts underway to create a better informed patient.

9:55 Engaging Patient Communities for Clinical Research

Jones_JanetJanet Jones, Ph.D., Vice President, Strategic Patient Engagement, Synexus Clinical Research Limited

There are many ways to build patient communities and get patients engaged to join a study. These range from conventional community interactions with patients or their healthcare providers through to online engagement with social media. To be fully engaged and chose to join a clinical trial, the patient must be at the heart of our thinking. This session will use case studies to explore the impact of using targeted approaches to engage with different patient communities and the pathway from engagement to randomisation.

10:20 Coffee Break


INTEGRATING PATIENT INSIGHTS AND DATA ANALYTICS TO IMPROVE TRIAL PLANNING, CLIN OPS, INVESTIGATOR RETENTION AND PATIENT ENGAGEMENT

Special Shared Session

10:35 Chairperson’s Remarks

Leventhal_DavidDavid Leventhal, Director, Clinical Innovation, Worldwide Research & Development, Pfizer


10:40 The Challenges and Solutions on Achieving True Patient Centricity: The Site’s Perspective from a Data Exchange, Study Design, Technology and Personal Perspective

Pierre_ChristineChristine Pierre, Founder and President, Society for Clinical Research Sites (SCRS)

As sites we are privileged and responsible for providing the “personal touch” between the clinical trial and the patients. This unique relationship provides invaluable information for industry stakeholders to gain first hand knowledge of the realities of the study experience and it’s impact on truly making the clinical trials a patient centric experience. Data and perspective will be shared regarding the impact of lack of data exchange, study design, technology and more will be discussed in a lively session aimed at making patient centricity a reality and not a phrase.

Worldwide Clinical Trials11:05 Rebuilding Site Partnerships to Optimize Study Execution

Jeffrey ZuckerJeffrey Zucker, MS, Vice President, Feasibility and Recruitment Optimization, Worldwide Clinical Trials

A barrier to successfully completing a clinical trial can be patient recruitment. While there may not be one solution to the issue, a key point has been lost over the last 20 years ― the relationship between site and sponsor. Although the merits of direct patient access cannot be denied, we need to re-engage our sites. Through these alliances, we will be able to increase efficiency with trial start-up, recruitment, and implementation. This discussion will suggest various methods to establish and maintain these key relationships while defining the impact on successfully conducted trials.

11:30 CO-PRESENTATION: Integrating Data Science into Clinical Trial Planning and Operations

Profit_DebbieDebbie Profit, Ph.D., Director, Corporate Projects, Otsuka Pharmaceuticals Development & Commercialization


Shashank_RohatagiShashank Rohatagi, Ph.D., Senior Director, Translational Medicine and Think Team, Otsuka Pharmaceuticals Development and Commercialization


The use of technology in the support of clinical trials has continued to increase. However, the disciplines and departments remain very distinct and in some cases siloed. In order to gain the most from your data, to make better decisions based on the data, to formulate more effective trial strategy, and to improve trial operations processes, there must be a more fluid interchange between the data scientists and trial planners.

11:55 Implementing a Patient Centricity Platform to Better Engage Patients and Sites in Informed Consent Process

Allen_RobertRobert Allen, Senior Director, Digital Innovation Group (DIG), AstraZeneca

Often we forget the human-side of a clinical trial. With trial design, protocol development, and clinical data as primary concerns, we forget engaging patients and investigators is just as important. Engagement can lead to a greater understanding of the trial with the hopes of making the experiences better for everyone. This talk will focus on striking the balance between creating trial effectiveness and efficiency through technology, while putting humans at the center through a use case of implementing the Patient Centricity platform to engage patients better in informed consent process.

12:20 INTERACTIVE PANEL: Can We Shift Investigators from “1 and Done” to Repeat Performers

Sears_ClaireClaire Sears, Ph.D., Director, Investigator Engagement, SiteStart, DrugDev


Immo ZadezenskyImmo Zadezensky, PharmD, Ph.D., Clinical Pharmacologist, Professional Affairs and Stakeholder Engagement (PASE), Office of the Center Director, CDER, FDA


Pierre_ChristineChristine Pierre, Founder & President, Society for Clinical Research Sites (SCRS)


Jeffrey_RoseJeffrey Rosen, M.D., Medical Director, Clinical Research of South Florida; Associate Professor, University of Miami Miller School of Medicine


In this session we will discuss the problem of investigator turnover – in particular, the large ‘1 and done’ population. Tufts will present information from the FDA 1572 database on the trends, characteristics and size of the ‘1 and done’ population. This information will be supplemented by a presentation of findings from the Investigator Databank related to characteristics of approximately 70,000 ‘1 and done’ sites including site level performance amongst other factors (e.g., geography, pediatrics, therapeutic area). It is clear that the high rate of attrition of investigators and the need to initiate new investigators is detrimental to site and overall trial performance, and is costly and time-consuming for sponsors. The session will conclude with a commentary on the data from the Site perspective regarding what can be done (if anything) to decrease the rate of investigator turnover. The learning objectives for this session are:

  • Learn detailed characteristics of the global population of investigators who have only participated in one clinical trial
  • Identify factors that can be gleaned from these detailed analyses that help identify investigators at risk of only participating in a single clinical trial
  • Based on these insights, discuss strategies/actions that can help reduce the likelihood of future site turnover

12:45 Closing Remarks

12:50 pm SCOPE 2016 Conference Adjourns (see you back in Miami in 2017!)


Suggested Event Package*

2:00 – 5:30 pm SC1: Implementing Social Media, Digital Marketing and Other New Strategies for Patient Recruitment - Detailed Agenda


February 23-24: Enrollment Planning and Patient Recruitment Conference

February 24-25: Patient Engagement, Enrollment and Retention through Tech, Disease Communities and Advocacy Groups Conference

* Separate registration required