2023 Archived Content
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Feasibility, Site Selection and Study Activation

Analytics-Driven Trial Design and Execution for Site-Centered, Hybrid, and Decentralized Trials

17 - 18 October 2023

We are pleased to announce production of Cambridge Healthtech Institute’s “Feasibility, Site Selection and Study Activation: Analytics-Driven Trial Design and Execution for Site-Centered, Hybrid, and Decentralized Trials” being held 17-18 October 2023 at the InterContinental Barcelona-Fira Center in Barcelona, Spain. Early development planning, feasibility assessment, protocol development, and site selection are arguably the most critical components of the clinical trial process. Performing these first steps effectively will significantly impact the likelihood of completing the trial on time and within budget. Innovative data and analytics capabilities, new protocol development and feasibility assessment processes, and novel approaches to stakeholder communication and collaboration are improving clinical trial timelines and outcomes and driving trial success.

Monday, 16 October

– 19:00 Innovation Day at SCOPE Europe with IQVIA Technologies14:30

Join IQVIA Technologies’ digital product leaders and customer success experts for an afternoon of discussions and demos. We’ll share our vision to transform clinical operations, the progress we’ve made to date, and our roadmap for 2023 and beyond.

Learn more & RSVP*

*Registration is limited to pharmaceutical, biotech companies, and research sites. IQVIA reserves the right to decline any registration.​

Tuesday, 17 October

Registration and Morning Coffee07:45

EARLY PLANNING AND ENGAGEMENT METHODOLOGIES AND METRICS TO OPTIMIZE PROTOCOLS AND PROCESS

08:50

Organizer's Welcome Remarks

Eileen Murphy, Associate Conference Producer, Production, Cambridge Healthtech Institute

08:55 Chairperson's Remarks

Laurence Birch, CEO, Anju Software

09:00

Early Engagement: A New Approach for Operational Input to Streamline Process and Optimize Study Design and Conduct

Agata Wiesiolek, Senior Director, Study Management, AstraZeneca Pharma Poland Sp. z o.o.

Operational complexity increases site and patient burden, significantly impacts patient recruitment, and causes inefficiencies including protocol amendments and re-feasibility—which wastes resources. Furthermore, in an environment where competition for sites is fierce, we must do all we can to use sites effectively and make studies attractive for investigators. By increasing engagement with Clinical Project Teams early, we are better positioned to enable innovative study design and secure ambitious, but achievable study plans.

09:25

CO-PRESENTATION: Patient Voice Methodology to Choose to Obtain the Appropriate Protocol-Specific Insights

Alyson Gregg, Director, Patient Insights, Janssen Pharmaceuticals, Inc.

Lieven Van Vijnckt, Head, Investigator & Patient Engagement, Infectious Disease and Vaccines (ID&V), Janssen Pharmaceuticals, Inc.

This presentation will describe the two methodologies to obtain the appropriate insights at the right stage of clinical development. For example, comparing the recommended methodology to obtain protocol-specific, stand-alone engagement, soliciting feedback from protocol-designated target patient population. Versus feedback from a generalized patient population representing areas of study within the TA, with the opportunity to solicit input for a wide variety of purposes and meet “just-in-time” requirements.

09:50 CO-PRESENTATION:Optimising Clinical Trials Using AI Driven Real-World Data

Tina Marshall, Head of Commercial, Akrivia Health

Jane Twitchen, Head, Clinical Trial Accelerator Unit & Senior Director, Global Clinical Operations, Biogen

With the drive to precision medicine and the need for a more focused approach to recruitment, this session will focus on how Biogen and Akrivia have worked together to accelerate the clinical trial recruitment process, targeting the right patients, at the right time, for the right trial.

10:15

Get Your Metrics Right: Understanding the Nuts and Bolts of Successful Recruitment during the Feasibility and Planning Stage

Frank Berger, PhD, Global Clinical Operations, Head of Analytics, Boehringer Ingelheim Pharma GmbH & Co. KG

The causal chain to successful recruitment will be dissected. Informative metrics bring transparency to each step and allow the identification of bottlenecks. The framework presented here enables the prediction of recruitment timelines, both during the feasibility and planning stage, as well as during start-up and recruitment.

10:40 Finding the Magic in the Middle: Combining Patient, Site and RWD Ingredients to Ignite Study Activation

Melissa Harris, Director, Senior Global Patient Engagement, Fortrea

Optimizing protocols & processes for better engagement methodologies need not be some strange alchemy! But it is about getting the ingredients right. In this presentation, we will challenge assumptions about the right type and quantity of ingredients, and the right moments to be adding them to a protocol cauldron to transform patient engagement and study activation

Grand Opening Coffee Break in the Exhibit Hall10:53

OPENING KEYNOTE: CLIN OPS AS A GROWTH DRIVER & EU TRANSPARENCY REGS & GLOBAL DCT ADOPTION THROUGH COLLABORATION

11:50

Organizer's Opening Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

11:55 KEYNOTE PRESENTATION:

Clinical Ops as a Growth Driver

Deirdre BeVard, Senior Vice President, R&D Strategic Operations, CSL Behring GmbH

Clinical Operations is the hardest job you'll ever love. It drives the growth of a clinical development portfolio that results in new therapeutic options for the patients who need them. This awesome responsibility may look "easy" from the outside, but starting and managing a clinical trial is like launching a new business into a saturated market each and every time. Let's talk about how inspiring you are!

12:20 KEYNOTE PRESENTATION:

Returning Results to Patients—Not Just a Regulatory Requirement with a Grace Period

Kimbra Edwards, PhD, Senior Director, Health Communication Services, Center for Information and Study on Clinical Research Participation (CISCRP)

EU Regulation/2014/536 requires results from trials initiated after January 2022 to be shared publicly within a year of completion and yet some sponsors are not sharing results. Several EU countries have successfully turned up the heat on sponsors who haven't shared the findings of their clinical trials actively pushing negligent sponsors and investigators to publicly share the results of past trials, an enforcement practice that's picked up momentum. After attending this presentation, the audience will: recognize the importance of returning trial results, in plain language, to all trial participants; describe the ramifications of not submitting plain language results; and plan for a large-scale implementation plan for returning results.

12:35 INTERACTIVE PANEL:

Navigating Global DCT Adoption—Driving Change through Collaboration

PANEL MODERATOR:

Angela Radcliffe, DTRA Member & Founder, How Mighty We Ventures

Global clinical trial teams are increasingly interested in using decentralized trial (DCT) methods. DCT technology and service providers have created a large variety of solutions for trial teams to use. However, there is no curated ‘source of truth’ accessible for providers or trial teams to understand which solutions can be used in which countries. The DTRA Regulatory Conduct Map initiative team has been focused on addressing this gap as part of its initial priorities to support the adoption of DCTs globally. In this session, initiative team members will share their approach to solving this challenge and how to use the deliverable they’ve created. Panelists will also share case studies on the application of this tool, and how it’s helping drive understanding and adoption of DCTs globally.

PANELISTS:

Dylan Bechtle, Associate Director, Regulatory Policy and Intelligence, The Janssen Pharmaceutical Companies

Megan Heath, Vice President, Region Head, Clinical Studies Unit Europe, Sanofi

Join Your Peers for a Networking Luncheon in the Exhibit Hall13:00

PREDICTIVE ANALYTICS TECHNIQUES IN STUDY FEASIBILITY AND SITE SELECTION

14:35

Chairperson's Remarks

Sylvia Marecki, PhD, Head, Operational Design Center (ODC), Global Development Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

14:40

CASE STUDY: Applying Causal Inference to Study Feasibility: Lessons Learned from Odesa

Sylvia Marecki, PhD, Head, Operational Design Center (ODC), Global Development Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Leveraging data science in study feasibility is becoming essential, since it can improve the accuracy and efficiency of the process, resulting in better decision-making, cost savings, and improved study design. The audience will gain a deeper understanding of benefits of applying data science to assess the feasibility of studies and inform operational planning decisions. Now with our model operationalized, we will share our lessons learned.

15:05 CO-PRESENTATION:Diversity by Design: Ensuring More Inclusive Studies with Real-World Data

Megan Heath, Vice President, Region Head, Clinical Studies Unit Europe, Sanofi

Jim Phillips, Vice President, Account and Partnership Management, TriNetX

Having representative patient populations in your trial designs is crucial to understanding disease and designing successful clinical trials. Evaluating patient eligibility criteria and its impact on enrollment helps us anticipate and adjust these criteria when it’s most crucial: before your study even begins.

15:30

Challenges of Using Predictive Analytics Techniques in Site Identification/Selection and the Known-Unknowns in Predicting Highest-Performing Sites

Kieran Whelton, Data Scientist, Data Science & Analytics, AbbVie, Inc.

Many large pharmaceutical sponsors are using predictive analytics techniques to create site lists for new studies with predictions on potential site performance. The creation of these predictions has multiple challenges in terms of the quality of data used, data sources, indications to include/exclude, site competition and how many years of data to include. This presentation will share some of the issues identified, potential solutions and information that is not being considered in the predictive modeling.

15:55 CO-PRESENTATION:Practical Approaches to Faster Study Start-Ups

Raphaelle Gilg, Strategy & Operations Manager, Novartis

Lena Nilsson, Senior Director, Global Site Activation, IQVIA

KK Rumrill, Senior Director & GM, Trial Management, IQVIA Technologies

Study start-up is more than document exchange – it is a strategic operation that can get new drugs approved faster. In this session you will learn: Strategies to drill down into the root cause of study start-up and site activation delays; How to use organization, process, and technology levers to claim extra days, weeks, and months in site activation timelines; and How to start studies faster despite regulatory and economic headwinds.

16:20 CO-PRESENTATION:Speed to Access – Simplifying Study Start Up for All Clinical Users!

Kevin Hancock, Director, Sales Engineering, Exostar

Megan Heath, Sanofi

Join us as we discuss innovative strategies to empower sponsors to streamline study start-up processes, enhance the clinical site experience, and eliminate the technology burden that often hinders research efficiency. Uncover practical solutions that will drive smoother operations, enhance collaboration, and ultimately accelerate advancements in clinical research. Don't miss this opportunity to explore options that elevate the sites experience and help speed drugs to market.

IMPROVING PROTOCOL, DESIGN, AND PARTICIPANT SELECTION THROUGH INTERACTIVE FEEDBACK

16:32

CO-PRESENTATION: When Recruitment Starts during Protocol Design and Participant Selection

Karim Keddad, MD, PhD, Medical Director, Geneuro

Xavier Morato Arus, PhD, Deputy Director, Clinical Trials, Ace Alzheimer Center, Barcelona

Average drop-out rate in clinical trials is calculated in a 20-30% of the recruited study population. Long studies, such as de ones designed in early stages of neurodegenerative diseases, must consider specific measures to decrease drop-out rates. Key elements of clinical trial retention include: protocol design, proper candidate selection, high quality informed session for patients and caregivers and an enthusiastic clinical trials team. We will explain the relevance of recruitment from the perspective of a Clinical Site and a small Biotech. And, we will discuss differences that make small pharma more efficient in going from protocol design to start-up and end of study based on a much better and direct communication with sites.

Welcome Reception in the Exhibit Hall with Beer, Wine, and Tapas16:57

Close of Day18:00

Wednesday, 18 October

Registration and Morning Coffee08:15

PRACTICAL DCT IMPLEMENTATION CASE STUDIES FROM EARLY FEASIBILITY THROUGH START-UP

08:45 Chairperson's Remarks

Alexandra Moens, Director Product Marketing, Marketing, H1

08:50

Practical DCT Implementation in Interventional Clinical Trials: Case Studies in Hybrid and Fully-Remote Approaches

Angela May, PhD, Head DCT Strategy & Implementation, Clinical Operations, Bayer Plc

We have successfully implemented hybrid and fully remote approaches across Phase III, pivotal/life cycle management interventional trials, each progressively broader and bolder in its DCT approach. Operational implementation remains highly challenging and there are many limitations, but our significant experience now allows us to share practical guidance and recommendations to pave the way for the next generation of DCTs.

09:15 CO-PRESENTATION:Operationalizing a Virtual Site: Insights from Bayer and Science 37’s DCT Journey

Darcy Forman, Chief Delivery Officer, Science 37

Angela May, PhD, Head DCT Strategy & Implementation, Clinical Operations, Bayer

The optimal clinical trial design is not a one-size-fits-all approach. Just as each clinical trial has its own unique characteristics, the elements of DCT require tailored integration to harmonize with specific protocol requirements. Explore perspectives on trial execution, the significance of change management, and how DCTs are used to maximize patient centricity.

09:40

CO-PRESENTATION CASE STUDY: IMI Trials@Home’s DCT Learnings from the RADIAL Study

Megan Heath, Vice President, Region Head, Clinical Studies Unit Europe, Sanofi

Mira Zuidgeest, PhD, PharmD, Associate Professor, University Medical Center Utrecht; Academic Lead IMI Trials@Home

With the Trials@Home proof-of-concept study, RADIAL, in full swing at the time of this presentation, we will provide you with an overview of the learnings for decentralised clinical trials so far, from choosing the technology and operational set-up, through CTIS approval and local regulatory requirements, to the learnings gained during start-up, recruitment, and follow-up.

10:05 The Why and How: Feasibility, Site Selection, and Study Activation

Chris Gardella, Vice President, Sales, Sales, H1

In this informative session, we'll explore the HOW and WHY understanding past performance for clinical trial sites can ensure the success and efficiency of future trials; how it’s been used historically; and the challenges that still persist for clinical trial site planning and feasibility teams.

Coffee Break in the Exhibit Hall, Special Book Signing, and Best of Show Winner Announced!10:17

Digital Health and Patient Data: Empowering Patients in the Healthcare Ecosystem

Authors: 

Disa Lee Choun, Head of Integrated Clinical and Operational Analytics, Janssen

Anca Petre, PhD, Co-Founder, 23 Consulting

Clinical Research News' Best of Show Award:10:30

Recognizing Exceptional Innovation in Technologies Used by Clinical Research Professionals

Allison Proffitt, Editorial Director, Bio-IT World

Sponsored by Clinical Research News & ClinEco

The 2023 Best of Show Awards offer exhibitors of the SCOPE Summit Europe an exclusive opportunity to distinguish and highlight their products, ranging from an innovative application, technology, tool, or solution. The SCOPE community is invited to identify exceptional innovation in technologies used by life science professionals, voting on most impactful new products of the year. Submit your entry! https://www.scopesummiteurope.com/sponsor-exhibitor/best-of-show-awards

MORNING KEYNOTE: MOVING eCOA, ePRO, e-SOURCE, EDC, AND ANY OTHER "e" INTO REALITY IN A DIGITAL HEALTH WORLD

11:00

Organizer's Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

11:05 INTERACTIVE PANEL:

eCOA- and ePRO-Centricity in a Digital Health World

PANEL MODERATOR:

Andrew Studna, Editor, Applied Clinical Trials, MJH Life Sciences

As digital health technologies make strides in collecting objective data from patients remotely, how does ePRO and other eCOAs fit within a holistic, patient-centered approach to quality data collection in clinical trials? This panel will discuss the importance of and differences among digital endpoints, digital biomarkers, and eCOA/ePRO.

PANELISTS:

Estrella Garcia Alvarez, PhD, Director, Global Clinical Operations, R&D, Almirall SA

Scottie Kern, Executive Director, eCOA Consortium, Critical Path Institute

Bryan McDowell, Vice President, eCOA Clinical Science & Consulting, eCOA Science, Clario

Bart Roofthooft, Head of Digital Health Solutions, EBIS/DHCoE, Janssen R&D

11:30 INTERACTIVE PANEL:

From Concept to Reality—The eSource-to-EDC Revolution Gathers Pace

PANEL MODERATOR:

Mats Sundgren, PhD, Senior Industry Scientific Director, i-HD (European Institute for Innovation through Health Data)

The eSource data captured daily in hospitals’ EHRs is increasingly gaining traction within the clinical research community as the basis of a powerful opportunity to transform the way clinical trials are run. This session discusses the potential and the challenges of direct transfer of clinically-validated data from EHR-to-EDC: Is there now a common impetus for investment in data quality by sites and sponsors? Can advances in technology deliver flexible and scalable solutions for EHR-to-EDC data transfer?

PANELISTS:

Peter Casteleyn, Director, Clinical Data Collection Solutions-EHR, The Janssen Pharmaceutical Companies of Johnson and Johnson

Paul Jacobs, Associate Director, Development Innovation, Regeneron Pharmaceuticals

Joe Lengfellner, Senior Director, Clinical Research Informatics, Memorial Sloan Kettering Cancer Center

Join Your Peers for a Networking Luncheon in the Exhibit Hall12:00

BETTER PREDICTING PATIENT DROP-OUT IN CLINICAL TRIALS TO IMPROVE PLANNING AND INTERVENTION

13:55 Chairperson's Remarks

Ryan Jones, CEO, Florence Healthcare

14:00

Prediction of Patient Premature Treatment Discontinuation in Clinical Trials

Ruben Buendia Lopez, PhD, Associate Director, Data Science, AstraZeneca R&D

Premature study drug discontinuation is a major challenge in clinical trials. If patients more likely to discontinue could be identified at baseline, intervention to prevent trial disengagement could be executed. With data from five Phase 3 trials, machine learning models were implemented using patient characteristics, concomitant medications, medical history, and questionnaires, at baseline. Within-trial testing was performed on 30% of patients unseen by the models. This was repeated ten times using bootstrap. Thereafter, SHAP values were estimated to evaluate predictors. AUROC medians ranged from 0.57 to 0.69. Location was the strongest predictor followed by age. In conclusion, information captured at baseline does not suffice to make accurate predictions of patient attrition.

14:25 Learnings from a 100% Digital Screening Process and Implications for Study Timelines

Ryan Jones, CEO, Florence Healthcare

Stephanie Reichle, Senior Associate Central Clinical Services & Innovation, Eli Lilly

14:50 Think Ecosystem – How Seamless Technology Integration is a Win/Win for Everyone

Jennifer Duff, General Manager, Zelta, Leadership, Merative

Nothing in clinical research happens in a vacuum and the more trials evolve and research moves closer to the natural point of care, the more it requires an ecosystem of technological solutions to access the right insights. “Thinking ecosystem” is critical to solving key industry challenges, including obstacles related to decentralized clinical trials. Join us as we discuss the power of business partnerships and outsourcing to support data integration.

Session Break15:15

CLOSING KEYNOTE: CLINICAL RESEARCH NEWS, TECH TO ENABLE PATIENT-CENTRIC TRIALS & BUILDING SUCCESSFUL OUTSOURCING PARTNERSHIPS

15:20 Organizer's Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

15:25

CASE STUDY: Patient-Centric Sampling Solutions in Action

Lewis Millen, Global Clinical Sciences & Operations Innovation Lead, UCB

Chiara Rospo, Bioanalytical Scientific Manager Development Science, Translational Biomarkers & Bioanalysis, UCB Pharma SA

Real case studies of implementation of a patient-centric sampling solution at UCB will be discussed, highlighting the complexity and the skills required to be successful. Tips on overcoming challenges will be shared.

15:35 INTERACTIVE PANEL:

Patient-Centric Blood Sampling as an Enabler for Decentralised Clinical Trials

PANEL MODERATOR:

Neil Spooner, PhD, Co-Founder and Chair, Patient Centric Sampling Interest Group (PCSIG)

In order to fully realise the potential for enhancing patient recruitment and retention for DCTs, the impact of blood sample collection for the determination of pharmacokinetics, measurement of biomarkers, and clinical chemistry also needs to be considered. This interactive panel will introduce you to technologies and workflows that enable the collection of these samples in the patient's home, either by self-sampling or by a caregiver, thus increasing patient choice and engagement. By attending this session, you will learn: What PCS is; What the potential benefits are when incorporating patient-friendly blood sampling into DCTs; Practical considerations on how to implement into your DCTs.

PANELISTS:

Silvia Alonso Rodriguez, Associate Director, Operations Lead, TSEM (Translational Science & Experimental Medicine), AstraZeneca

John Corcoran, Director, Decentralized Trial Solutions, Q² Solutions

Lewis Millen, Global Clinical Sciences & Operations Innovation Lead, UCB

Chiara Rospo, Bioanalytical Scientific Manager Development Science, Translational Biomarkers & Bioanalysis, UCB Pharma SA

16:00 PANEL DISCUSSION:

Unlocking the Crucial Ingredients for a Successful Outsourcing Partnership: Time to Challenge the Status Quo and Focus on Value-Based Contracts

PANEL MODERATOR:

Sylvia Marecki, PhD, Head, Operational Design Center (ODC), Global Development Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

The pharma industry is facing ever-increasing challenges. Our trials are becoming more complex, requiring greater flexibility, and technology is changing at a fast pace. Now is the time to rethink our outsourcing models. Our dialogue needs to focus on outcomes and value generation rather than arguing over the small things which can stifle innovation. How confident are you with your current approach, and what are the risks and consequences of sticking with the status quo? Our esteemed panel of experts, with diverse backgrounds, will explore how true value can be unlocked from collaborative partners. Key topics include: 1) Creating the right partnership and alliance culture to ensure the best outcome for both the sponsor and vendor; 2) How have procurement functions adapted in defining and measuring value-based contracts?; and 3) Incentivizing and rewarding innovation, and collectively owning a change in strategy.

PANELISTS:

Jason Gubb, Co-Founder, ClinOpsClarity and Emergent Teams

Piet Theisohn, Vice President, Resource Management, Clinical Development & Operations, Bayer AG – Pharma

Jane Twitchen, Head Clinical Trial Accelerator Unit & Executive Director, Global Clinical Operations, Biogen Ltd.

Julia Vassiliadou, PhD, Vice President, Clinical Operations, F2G

Close of Summit16:25