2nd Annual

Patient Recruitment & Site Selection

Improving Patient Recruitment and Site Selection through Novel, Patient-Centric Approaches 

April 24-25, 2017

The success of a clinical trial hinges upon 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 recruitment and site selection techniques using novel, patient-centric and data-driven approaches.

Monday, April 24

7:25 am Conference Registration and Morning Coffee

INVOLVING THE PATIENT IN RECRUITMENT AND CLINICAL TRIALS

8:25 Chairperson’s Opening Remarks

Robert Loll, Vice President, Business Development & Strategic Planning, Praxis

8:30 Reciprocal Patient Relationships before, during and after Trials

Jeremy Gilbert, Vice President, Product & Strategy, PatientsLikeMe

Patients rarely consider research when they are not in a clinical trial, and when they do participate, rarely build any long term connection with other patients or the research they were a part of. The result is disappointed patients and a perpetual challenge in recruiting the next generation of trial participants. In operating a research-oriented, “data for good” network, PatientsLikeMe has developed a number of powerful methods for creating continuous, reciprocal, long-term research relationships with patients. This talk will share what we’ve learned and discuss its applications to clinical trials.

9:00 Social Media as a Vehicle for Enhancing Patient Involvement in Medicine Development

Phil Golz, Executive Vice President and Chief Revenue Officer, HealthUnlocked, Inc.

Historically, medicine development has been very much focused on the science and evidence required to gain medicine authorization and reimbursement. But today, with more and more medicines targeting the same disease and/or pathway and with ever greater stratification of patient populations within disease areas, involving patients has never been more important. Social Media, with its broad reach and consumer friendly interfaces is becoming an ever more important channel to reach, educate and engage patient populations and can be used to help industry design better trials, which are more suited to the patient populations they seek to serve.

9:30 Informed Consent: Moving from Lawyer-Friendly to Patient-Friendly

Julie Walters, Founder, Raremark

For far too long, patients in clinical trials have had to read and sign a 20-page legalistic tome to take part in a clinical trial. Legal and compliance may be delighted by the output but do patients really understand what they are signing? Is there another way of gathering informed consent that is truly understood by the patient AND ticks the boxes for legal and compliance? Raremark has developed a new way of working with patients that is user-led, patient-friendly and ethical. Hear how the new approach works in the real world and how it is possible to put users first, compliance second.

10:00 Networking Coffee Break

SITE SELECTION & FEASIBILITY INSIGHTS

10:30 Novel Approaches to Site Feasibility

Amanda Hayden, Director, Global Clinical Services, Study Start Up, Alkermes, Inc.

This presentation will focus on unique ways to explore site capabilities for participating in clinical trials. Given the limits in standard feasibility questionnaires, it is helpful to apply varied approaches to assess site interest and capacity for performance. Employing different techniques to improve early site feasibility efforts has a dramatic effect on ensuring the inclusion of the right sites for your clinical programs.

11:00 Setting and Achieving Site Performance Targets: Starting at Site Selection

Brendan O’Neill, Senior Director, Patient Recruitment Programs, Global Clinical Trial Execution, Pfizer

In order to drive down the number of non-performing sites, we are working with our CRO partners to validate a site’s access to patients at the time of site selection and establishing a site specific recruitment plan to ensure that sites hit their contracted target. In this session, you will see how planning and technology can come together to ensure that sites and studies are set up for success. You will see the successful impact of this approach at initial study planning and rescue situations.

11:30 Precise and Accurate Site Selection Targeting

Robert Wynden, Ph.D., Vice President, Technology & Engineering, Product Development, goBalto

Site selection is best performed when sponsors/CROs use a data-driven approach to create a target site profile based on an algorithm that uses a weighted average of feasibility, study startup metrics, and site experience, informing decisions on the effectiveness of sites to be made.

11:45 Patient Recruitment: Setting Up Studies for Success

Martin Collyer, COO, Patient Recruitment and Retention, Bioclinica

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

12:45 Session Break

NEW TECHNOLOGIES FOR MORE EFFICIENT PATIENT RECRUITMENT & SITE SELECTION

1:25 Chairperson’s Opening Remarks

Robert Loll, Vice President, Business Development & Strategic Planning, Praxis

1:30 Leveraging Digital and Social Media: How Patient Insights and Discoverable Data Can Lead to More Effective and Efficient Patient Recruitment Campaigns

Robert Loll, Vice President, Business Development & Strategic Planning, Praxis

2:00 Social & Digital Media for Accelerating Patient Recruitment

Heather Hernandez, Clinical Operations Manager, Menlo Therapeutics

As more patients seek health information online, social and digital media become powerful tools for patient engagement and enrollment in clinical trials. This presentation will provide a case study of using social media for a clinical trial recruitment plan and the key learnings from our experience.

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.

Click here for details.

4:15 Welcome Reception in the Exhibit Hall

5:30 Close of Day

5:30 Dinner Short Course Registration

Tuesday, April 25

7:25 am Morning Coffee

DATA-DRIVEN PATIENT RECRUITMENT AND SITE SELECTION

7:55 Chairperson’s Opening Remarks

Robert Loll, Vice President, Business Development & Strategic Planning, Praxis

8:00 Data-Driven Patient Recruitment with Real World Data at Roche pRED

Liping Jin, Data-Driven Recruitment Lead, Pharmaceutical Research & Early Development, Roche Innovation Center New York

With the increasing use of Real World Data (RWD) in the pharma industry, the Data-Driven Recruitment (DDR) team at Roche Pharm Research & Early Development (pRED) would like to share our experience of integrating RWD (e.g. insurance claims, EMR) with trial metrics data to optimize study protocol design and target patient recruitment strategy. While the team has received positive feedback from our business partners (translational medicine, clinical program teams, and study leaders), we would like also to share the challenges to expanding the effort in broader US and international settings.

8:45 Site Selection and Trial Execution- Pearls and Pitfalls

Darin Curtiss, Pharm.D., Vice President, Clinical Development, Orphanos

9:00 Optimizing Clinical Research through Insight Generation and Data-Driven Approaches

Martine Lewi, Scientific Director, Quantitative Sciences, Real World Evidence, Medical Affairs, Established Products Statistics (RMEDS), Janssen

The presentation starts from a European perspective on health data re-use for optimizing clinical research, comparing the situation – from a data user perspective – with practices in other regions. Lessons learned from the public/privately funded Innovative Medicine Initiative EHR4CR will be shared and the objective of open collaboration with different stakeholders will be emphasized, aiming at the development of a sustainable ecosystem where new partnerships can emerge and clinical research can be optimized through early insight generation.

9:30 Recruiting Beyond Traditional Patient Populations. A Risk-Free Approach

Ivor Clarke, CEO, SubjectWell

The statistics are familiar - only 4% of Americans have ever participated in a clinical trial and less than half can even recall seeing an ad for patient recruitment. Accelerating enrollment requires growing the total population of people participating. We’ll discuss a unique approach that leverages learnings from other industries.

9:45 Who’s Keeping Score? A Quantitative Approach to Trial Feasibility

Luke Stewart, MBA, Director, Product Management, Saama Technologies

With most trials failing to meet enrollment timelines, current approaches for feasibility fall short of identifying and minimizing risk. Sponsors must arm themselves with the right tools to own this analysis throughout the trial lifecycle. We will discuss a quantitative approach that operationalizes feasibility score tracking.

10:00 Coffee Break in the Exhibit Hall

1:20 Close of conference. Stay on to attend Outsourcing for Clinical Trials.