Feasibility, Site Selection and Study Activation
（フィージビリティ、施設選定、治験の活性化）
施設中心、ハイブリッド、分散型治験のための分析主導型治験デザインと実行
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
EARLY PLANNING AND ENGAGEMENT METHODOLOGIES AND METRICS TO OPTIMIZE PROTOCOLS AND PROCESS
治験計画とプロセスを最適化する早期計画、エンゲージメント方法および指標
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.
CO-PRESENTATION: Patient Voice Methodology to Choose to Obtain the Appropriate Protocol-Specific Insights
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.
Talk Title to be Announced
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.
Talk Title to be AnnouncedGrand 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
PREDICTIVE ANALYTICS TECHNIQUES IN STUDY FEASIBILITY AND SITE SELECTION
治験のフィージビリティと施設選定における技術の予測分析
CO-PRESENTATION CASE STUDY: Applying Causal Inference to Study Feasibility: Lessons Learned from Odesa
Katra Kolsek, PhD, Senior Product Manager, Operational Design Center Global Development Operations, Merck KGaA
Sylvia Marecki, PhD, Design Analyst, Operational Design Center (ODC), Global Clinical 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.
Talk Title to be AnnouncedChallenges 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.
Talk Title to be Announced
Talk Title to be Announced
IMPROVING PROTOCOL, DESIGN, AND PARTICIPANT SELECTION THROUGH INTERACTIVE FEEDBACK
インタラクティブなフィードバックによる治験計画、デザイン、および患者選定の改善
CO-PRESENTATION: When Recruitment Starts during Protocol Design and Participant Selection
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
10月18日（水）
Registration and Morning Coffee08:15
PRACTICAL DCT IMPLEMENTATION CASE STUDIES FROM EARLY FEASIBILITY THROUGH START-UP
スタートアップによる早期フィージビリティから見た実際の分散型臨床試験のケーススタディ
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.
Talk Title to be AnnouncedCO-PRESENTATION CASE STUDY: IMI Trials@Home’s DCT Learnings from the RADIAL Study
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.
Talk Title to be AnnouncedCoffee 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
BETTER PREDICTING PATIENT DROP-OUT IN CLINICAL TRIALS TO IMPROVE PLANNING AND INTERVENTION
計画と介入を改善するための臨床試験における患者離脱のより正確な予測
Chairperson's Remarks13:55
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.
Sponsored Presentation (Opportunity Available)14:25
Talk Title to be AnnouncedSession 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。
