Enrollment Planning, Participant Engagement and Recruitment
（被験者登録計画、参加者エンゲージメント、被験者募集）
ハイブリッドおよび分散型治験における患者募集のスピードと多様性の向上
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
INCORPORATING PATIENT INSIGHTS TO INCREASE DIVERSITY AND ACCESSIBILITY IN TRIALS
治験の多様性と利用可能性の向上に向けた患者の視点の取り入れ
Leveraging Modern Solutions to Increase Patient Choice, Accessibility, and Diversity in Clinical Trial Conduct
Alekhya Pochiraju, Senior Product Development Lead, Clinical Operations, Genentech
The implementation of modern solutions to ensure clinical trial continuity and renewed strategies / approaches to advance Diversity, Equity and Inclusion in Clinical Trials (DEICT) has impacted all stakeholders involved in clinical research. As a result, there is a rich opportunity to understand the lessons learned. This information can be used to inform ways of working for researchers as well as future policies by regulators that could foster more routine consideration of hybrid or fully decentralized trials. This session will raise awareness and share key insights gathered from cross-industry subject matter experts that can help lead to a future where trial demographics include the same populations for whom the studied drugs are intended to be prescribed and additional patient-centric options are enabled alongside on-site trial operations.
FIRESIDE CHAT: A Patient Perspective on Walking the Walk of Patient Engagement
Patient engagement drives innovation and leads to better retention, trials that meet the needs of patients and faster approvals. Involvement of different types of patients is important, from Patient Organisations, Expert Patients to Lay Patients. There are today clear methods, tools, guidances and best practices available for implementing effective patient engagement. However, many challenges remain in implementing this vision. A clear need for education and training for sponsors on patient involvement has been identified. Resources are also a challenge, as changing the current procedures and a paradigm shift does require re-allocation of investment. There is also a need to build strong relationships with the patient community and enhance an open and transparent communication and exchange of information, especially within rare diseases.
Talk Title to be AnnouncedCO-PRESENTATION: Incorporation of Patients' Insights in New Ways of Working in Drug Development
Patient-centricity in R&D requires a different mindset and adaptation of ways of working in the pharma industry. Patients are a preferred partner to support this process. This presentation will share how the creation of an expert patient board with different cross-functional teams allows an organization to speed up what is an ever-changing process. The main results, experience, and lessons learned will be shared in this talk.
Sponsored Presentation (Opportunity Available)10:40
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
IMPROVING CLINICAL TRIAL OUTCOMES SYSTEMATICALLY WITH PATIENT FEEDBACK
患者のフィードバックによる臨床試験結果の体系的な改善
CO-PRESENTATION: Patient Voice in Clinical Trials: Evolution from Ad Hoc to a Refined Systematic Approach across Several Therapeutic Areas
This talk will focus on learnings of a larger R&D organization to ask, listen, and ACT along the lines “from insights to impact.” We will share examples of how patient voice has shaped protocol design or elements of the study conduct. In addition, we will share how to pilot and scale patient voice across different therapeutic areas - e.g., rare diseases vs. prevalent diseases.
Adults Don’t Always Know Best; In a Paediatric Study, Let's Go to the SourceThe perception that adults know best the thoughts and feelings adolescents have around their disease could not be further from the truth. When we engage with our adolescents, we gain insights into their behaviours and motivations. The importance of including their feedback prior to the development of a study are critical to success. Those we often think have the least to say have more to contribute than one could imagine.
CO-PRESENTATION: Improving Clinical Trial Outcomes with the Power of Patient Feedback
This innovative project by Cancer Research UK has enabled the development of a pioneering app that amplifies the voice of patients and enables researchers to better understand their needs and preferences. This talk will explain why patient feedback is crucial for improving recruitment and engagement in clinical trials, and why now is the right time for this new technology to be incorporated routinely in clinical trials.
Talk Title to be Announced
Talk Title to be AnnouncedSponsored Presentation (Opportunity Available)16:20
RETURNING DATA TO PATIENTS TO MODERNIZE AND PERSONALIZE TRIALS
治験の最新化および個別化するための患者へのデータの還元
Demystifying Individual Participant Data Return to Modernize and Personalize Clinical Trials
Jean Stimola-Sposaro, Director, Global Clinical Trial Industry Collaborations, Global Drug Development & Global Development Operations, Bristol Myers Squibb Co.
A paradigm shift: the role of individual participant data in advancing care options and drug development, commitments to a new mindset, and operational strategies to optimize meaningful, flexible, personalized clinical trial options that strengthen patient alliances and experiences, opportunities to evolve efficiencies, maximize cross-collaboration impact, and accelerate participant data-sharing models to facilitate interoperability of clinical data collection systems and bridge the gap between clinical care and clinical research.
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
ENABLING BROADER PATIENT ACCESS THROUGH TECHNOLOGY AND OUTREACH
テクノロジーとアウトリーチを通じた、より広範な患者アクセスの実現
Chairperson's Remarks08:45
CASE STUDY: Act4Patients Roadmap
Sanofi will share their clinical operations transformation project, Act4Patients. The overarching goal of A4Pts is to transform and simplify the clinical trial process for our patients and sites. In addition to simplifying for our patients, our other key transformations center on digitizing and automating our data and work, leveraging data and science to make decisions, raising trial awareness, and making trial participation an option for all patients.
Create Equitable Access with Data-Driven and Patient-Informed Recruitment and Enrollment
Rachel Horovitz, VP, Product Strategy, Medidata, a Dassault Systemes company
How can you be sure that your clinical trial will not only recruit but also ultimately enroll and retain a diverse participant pool? In this session, you will learn how you can access and leverage data, analytics, patient engagement, and feedback to tackle diversity from multiple angles throughout your trial, from study planning through recruitment and trial execution. Join Medidata representatives to hear how to establish diversity goals, enhance enrollment planning, and improve patient engagement and recruitment through a combination of industry-wide analyses, patient insights, and registries tailored to your trial.
Standardization Leads to Innovation: How MSD Developed a Scalable Global Clinical Trial Recruitment and Awareness Platform
Launching a global clinical trial recruitment platform at a large company, like MSD, can be an arduous process. Although difficult, standardizing the way our company brings clinical trial information to our global audience is critical to enhancing clinical trial awareness and education in addition to facilitating recruitment of clinical trials. Through partnership with our local in-country leads it is expanding with localizations incorporating local culture and nuances into each build for our major global markets. The platform enables new clinical trials to launch digital platforms and awareness campaigns with efficiency significantly reducing resource effort without sacrificing quality and compliance. MSD is effectively enabling flexible options for recruitment via this digital resource.
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
CHALLENGES AND OPPORTUNITIES: ENGAGING, ENROLLING, AND RETAINING PATIENTS IN DECENTRALIZED TRIALS
課題と機会：分散型治験における患者の参加、登録、維持
Chairperson's Remarks13:55
CASE STUDY: Nestle’s Fully Decentralized Study on Ketogenic Treatment for Migraines
Inez Sroda, Associate Clinical Project Manager, Clinical Research Unit, Nestle Research Center
Nestle has led a fully decentralized study on ketogenic treatment for migraines. All aspects of the trial were performed remotely including recruitment, screening, consent and study visits. Whether it's due to advancement in digital technologies, COVID-19 pandemic or increased focus on a patient-centric approach, decentralized clinical studies are becoming more common. However some sponsors still hesitate to implement fully decentralized studies due to the complexity or inexperience in this approach. We wish to share our first experience in conducting a decentralized study to help other sponsors understand some of the operational considerations and implications.
Developing an Attitude of Gratitude: A New Toolkit to Embed Gratitude for Our Clinical Trial Participants throughout the Clinical Trial Journey
Si Mohammed El Guerche, Global Operations Portfolio Lead, Bristol Myers Squibb Co.
Participants volunteer their time and bodies to support research and may not feel appreciated or acknowledged for their contribution. The TransCelerate Patient Experience team has assessed the landscape of clinical study support and appreciation to develop our Gratitude Toolkit. Bringing industry best practices and country network inputs together with patient advisor contributions, the toolkit balances templates and samples with use considerations.
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。
