Clinical Data Technology for Digital and Hybrid Trials
（デジタル治験とハイブリッド治験のための臨床データテクノロジー）
次世代治験のためのデジタル測定、RDW、AI
2023年10月17日〜18日
10月16日（月）
- 18:30 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.
10月17日（火）
Registration and Morning Coffee07:45
ENTERPRISE-LEVEL DATA STRATEGY FOR CLINICAL RESEARCH AND BEYOND
臨床研究とその先に向けたエンタープライズレベルのデータ戦略
Data-Driven Decision-Making in Clinical Research and Beyond
Disa Lee Choun, Head of Integrated Clinical and Operational Analytics (ICOA), Janssen, Pharmaceutical Companies of Johnson and Johnson.
Building a data infrastructure, leveraging new technologies, following privacy and data security regulations, and implementing data governance rules bring data management to the next level and allows data innovation to overcome internal and external silos.
Decentralized, Hybrid, and Real-World Evidence - Are They the Future of Clinical Trials?
This presentation will focus on the strategic steering of challenges and opportunities in the era of reshaping how we shall execute future clinical trials better, faster, and cheaper. We will detail the critical components to reform the current thinking and emphasize a harmonized ecosystem as a key enabler to drive success.
Talk Title to be AnnouncedRecent Advances in the Use of RWE for Regulatory Decision-Making
Gracy Crane, PhD, Global Regulatory Policy Lead for RWD, Roche Products Ltd.
Regulators across the globe have been publishing guidelines on the use of real-world data (RWD) for regulatory decision-making. This presentation will summarise the latest advances in terms of guidelines and initiatives that are being brought forward to enable RWD to support and accelerate drug development by global regulators. The presentation will also share complementary initiatives from scientific societies and consortia that are working in tandem to advance this field.
Trials on Platforms - Looking beyond Modern Trial Vocabulary
Thomas Rasmussen, Executive Vice President, Principal Consultant, Clinical Practice, Devote Consulting
There are many modern terms like DCT, with very broad and varying definitions and approaches for utilizing new ways of conducting trials. I propose to see trials consisting of building blocks through the clinical value chain. These building blocks put together is the platform a modern life science company should establish to execute its clinical ambitions (regardless of the vocabulary). Ensuring technology enablement goes beyond systems.
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
オープニング基調講演：成長の原動力としての臨床業務、欧州の透明性規制、協業による世界の分散型臨床試験の導入
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!
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.
Navigating Global DCT Adoption: Driving Change through Collaboration
Craig Lipset, Founder, Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)
Global clinical trial teams are increasingly interested in using decentralized trial (DCT) methods. DCT technology and services 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.
Join Your Peers for a Networking Luncheon in the Exhibit Hall13:00
RWD SOLUTIONS, APPLICATIONS, AND AI ENHANCEMENT
RWDソリューション、アプリケーション、およびAIの強化
AI for Evidence Generation: A Decade of Experience Is Enough to Stop Calling It Fiction
Raul Castellanos Moreira, MD, PhD Innovative Medicine/Rheumatology Spain & Portugal Disease Area Specialist in Rheumatology
Are you still skeptical about the potential of AI in evidence generation for pharmaceuticals? Since 2014, researchers, institutions, and pharmaceutical companies have been utilizing AI to generate solid evidence. Just as there are generalist AIs, such as chatGPT, there are specific AIs trained to read electronic medical records in multiple languages to generate disease-specific datasets. With journal editors and agencies now accepting clinical data analyses generated with machine learning, it's proven that this technology is not science fiction. However, tech is not an excuse to avoid a robust methodology that guarantees data quality; it´s more needed than ever, and there´s a methodology for that. Real cases? The use of AI to extract knowledge from healthcare provider information systems is not only making feasibility studies more agile, but also allowing to create "deep RWE," which allows for tracing patient journeys, obtaining epidemiological data, and comparing interventions with a fraction of the time and effort. Don't miss out on this game-changing approach to evidence generation, and witness firsthand a few examples that demonstrate the power of AI for trials.
Practical Applications of AI/ML in Clinical Data Science
Erin Erginer, Director of Product, Software, Pinnacle 21 by Certara
This presentation will explore the practical applications of AI/ML technology in clinical operations including data acquisition, management, and biostats, with a particular focus on the use of natural language processing (NLP). NLP can be used to extract information from study documents such as protocols and populate downstream data management systems. This has several benefits, including streamlining data operations processes, ensuring data accuracy and integrity, enabling faster data analysis, and increasing automation.
Methodologies and Analytical Approaches to Generate RWE
Katie Baca-Motes, Senior Director, Strategic Initiatives, Scripps Research Institute
At the Scripps Research Digital Trials Center (DTC), we focus, in part, on implementation science towards technologies and methodologies that promote the collection of RWD as well as the multi-modal analytical approaches towards generating RWE. This panel discussion will explore these methodologies, learnings and solutions from SCIPPS Research Institute and expert European Scientists in the field.
What Patients Really Think about eConsent & Why Sponsors Should Care
Andrew Mackinnon, Vice President, GM, eConsent, Customer Value, Medable
Traditional text-based paper consent has long been known to be less than ideal for patient comprehension; in fact it’s often described as intimidating. eConsent can present consent content in an enhanced way, resulting in a more effective and patient-centered approach to the process. Results of an evaluation of enhanced vs. a simple text based eConsent will be presented.
Talk Title to be AnnouncedA Privacy Methodology Toolkit to Improve Cross-Industry Clinical Data Reuse
Jeppe Manuel, Principal R&D Data Privacy Specialist, Novo Nordisk
Secondary use of clinical trial data can help accelerate the development of medicines by reducing patient burden, generating insights, and enabling evidence-driven decision-making. However, differences in the current data privacy methodologies can make data usability extremely challenging, especially for cross-study analysis. This presentation will explore the methodology toolkit resources and a summary of stakeholder input from the public review period.
Welcome Reception in the Exhibit Hall with Beer, Wine, and Tapas16:57
Close of Day18:00
10月18日（水）
Registration and Morning Coffee08:15
DIGITAL HEALTH IN CLINICAL TRIALS
臨床試験におけるデジタルヘルス
Increasing Transparency & Ownership of DH Deployment into Clinical Trials
Janssen has created a cross-functional process and board to support DH needs, a clear framework that ensures oversight and insight. The framework creates a single source of Digital Health technology information and operational support for clinical trials.
Modeling User-Centric Solutions in Healthcare Environments
The proliferation of digital health devices, such as mobile health apps, wearable sensors, and various consumer goods, show great potential for improving human health. Smartphones offer a large variety of sensor-based technologies, which enables the capture of active and passive real-time data in free-living settings that may fundamentally shift traditional paradigms of clinical monitoring. Clinical assessments of patients might be episodic and may miss important features of functional variations between medical visits. In this context, user experience plays a key role in the success of mobile applications as it is UX that motivates for further engagement and should be considered to design better products. UX factors have attracted increasing attention for the design of healthcare and medical devices since they provide important rational requirements to enhance usability, adherence, user perception and satisfaction. Different UX patterns may lead to different product design, and different UX design may be more effective for some users and in particular situations. In such settings, user experience goes beyond the reliable functionalities and effective usability.
Digital Measures - How to Scale and Unlock Value
Sponsored Presentation (Opportunity Available)10:05
Coffee Break in the Exhibit Hall and Special Book Signing10:17
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
MORNING KEYNOTE: MOVING eCOA, ePRO, e-SOURCE, EDC, AND ANY OTHER "e" INTO REALITY IN A DIGITAL HEALTH WORLD
モーニング基調講演：デジタルヘルスの世界におけるeCOA、ePRO、e-SOURCE、EDC、その他のあらゆる“e”の現実への移行
eCOA- and ePRO-Centricity in a Digital Health World
Lisa Henderson, Editorial Director, Applied Clinical Trials
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.
From Concept to Reality - The eSource-to-EDC Revolution Gathers Pace
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?
Join Your Peers for a Networking Luncheon in the Exhibit Hall12:00
ENABLING CLINICAL TRIALS
臨床試験の実現
Talk Title to be Announced
BYOD: The Critical Enabler of Digital and Hybrid Trials
An expert panel formed by Critical Path Institute’s eCOA Consortium will discuss how to bring-your-own-device (BYOD) approaches to patient-based data collection are central to digital and hybrid trial success. The presentations will share implementation best practices, experiences from the experts in the field, and identify opportunities for expansion of the use of BYOD approaches for eCOA and sensor-based wearables in decentralized clinical trials.
Benefits of Combining eClinical Technology with Trial Delivery and Management Expertise in a Hybrid COVID-19 Study
After the decline of the pandemic driven hype around full DCT, the industry is evaluating how digital technology, combined with traditional site-based trial conduct, can optimize study time, cost, quality of results. We will focus on a case study how a COVID-19 treatment trial achieves high recruitment rates and positive high data quality with a hybrid approach, using eClinical technology combined with strong expertise in study conduct and management.
Solving the Clinical Trial Data Transfer Challenge - Case Study
Joe Lengfellner, Senior Director, Clinical Research Informatics & Technology, Memorial Sloan Kettering Cancer Center
How advanced EHR-to-EDC technology is already transforming clinical trials - looking at progress to date and the real world experience of a leading research site that is using this technology.
Session Break15:15
CLOSING KEYNOTE: CLINICAL RESEARCH NEWS, SCOPE BEST OF SHOW AWARDS 2023, TECH TO ENABLE PATIENT-CENTRIC TRIALS & BUILDING SUCCESSFUL OUTSOURCING PARTNERSHIPS
クロージング基調講演：臨床研究ニュース、SCOPE BEST OF SHOW AWARDS 2023、患者中心の臨床試験を可能にする技術、成功するアウトソーシングパートナーシップの構築
Clinical Research News' Best of Show Award: Recognizing Exceptional Innovation in Technologies Used by Clinical Research Professionals (Sponsored by Clinical Research News & ClinEco)
Allison Proffitt, Editorial Director, Bio-IT World
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. Exhibitors are invited to enter your products via the online submission form below. Attendees are encouraged to explore the novel technologies and solutions firsthand in the exhibit hall and vote for the People's Choice Award once the conference has begun. Submit your entry!
https://www.scopesummiteurope.com/sponsor-exhibitor/best-of-show-awards
CASE STUDY: Patient-Centric Sampling Solutions in Action
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.
Patient-Centric Blood Sampling as an Enabler for Decentralised Clinical Trials
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 patients 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.
Unlocking the Crucial Ingredients for a Successful Outsourcing Partnership: Time to Challenge the Status Quo and Focus on Value-Based Contracts
Luiz Barberini, Head, External Manufacturing Operations, Bayer SA
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.
PANEL DISCUSSION: Unlocking the Crucial Ingredients for a Successful Outsourcing Partnership: Time to Challenge the Status Quo and Focus on Value-Based Contracts
Close of Summit16:25
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。
