DAY ONE: 16TH April 2024 - EST/EDT (Eastern Daylight, GMT-4)
DAY ONE: 16TH April 2024 - EST/EDT (Eastern Daylight, GMT-4)
- Len Rosenberg, Ph.D. - Head, Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society
a. Update on the released guidance
- Isaac Rodriguez-Chavez, PhD, MHSc, MSc - CEO & Principal Independent Consultant, 4Biosolutions Consulting Scientific, Clinical, Regulatory Affairs and Digital Health Technologies Co-Chair, IEEE-SA, Clinical Trial Technology Modernization Network (CTTMN)
a. What does this mean for infrastructure and the way clinical trials/ Full/Hybrid DCTs are conducted?
b. Case study
c. How can you make sure whatever tech you are implementing will accommodate patients
e. Looking at data integrity, logistics and cost
- Madeline Geday - Head, Patient Engagement & Clinical Strategy/Decentralized Clinical Trials, Astellas Pharma US
- Marc Lisi - Co-founder & Director, Customer Solutions, Suvoda
a. What does this mean for infrastructure and the way clinical trials/ Full/Hybrid DCTs are conducted?
b. Case study
c. How can you make sure whatever tech you are implementing will accommodate patients
e. Looking at data integrity, logistics and cost
- Madeline Geday - Head, Patient Engagement & Clinical Strategy/Decentralized Clinical Trials, Astellas Pharma US
- Sarah Valentine - Partnerships Lead, Life Sciences, Digital Medicine Society (DiMe)
- Mark Rice - Vice President, Digital Solutions, Precision Digital Health
- Thomas Wells - CEO, Co-Founder, Precision Digital Health
a. Case study
- Joseph A. DiMasi - Director of Economic Analysis and Research Associate Professor, Tufts Center for the Study of Drug Development, Tufts Medical School, Tufts University
- Zachary (Zak) Smith - Senior Data Scientist, Tufts Center for the Study of Drug Development, Tufts Medical School, Tufts University
- Jane Myles - Program Director, Decentralized Trial & Research Alliance (DTRA)
a. Case study
- Sumesh Kalappurakal - Senior Director, Clinical & Statistical Programming (Head, Technology Solutions), Johnson and Johnson, TransCelerate Digital Data Flow (DDF) Initiative
- Zachary (Zak) Smith - Senior Data Scientist, Tufts Center for the Study of Drug Development, Tufts Medical School, Tufts University
- Jane Myles - Program Director, Decentralized Trial & Research Alliance (DTRA)
- Digital Health Tech/Wearables
- Software/Medical Devices
- AI/Machine Learning
- eCOA/Clinical Outcome Assessments/ Virtual Investigator Meetings
- IRT Systems
- At Home Care
- Sergey Krymgold - Sr. Director, Head of Clinical Trial Tools & Technologies Global Development Solutions, Takeda
- Colin Cleary - Senior Vice President, Strategic Solutions, YPrime
- Marc Weinberg - Senior Director, RTSM, Medrio
a. In person vs. fully DCT
i. Hybrid – is this a happy medium?
b. What is truly the most patient centric approach; and what do the patients really want?
c. How can we tailor trial to be around patients needs
- Protocol to protocol, workflow to workflow
- What can we do to make the trial truly bespoke to the needs of the study and the patient?
- Mindy Gruba - Sr. Manager, Patient Centricity, Patient & Site Experience (PASE), Moderna
- DCT Operations
- Technical DCT and DHT standards
- Voice and experience of DCT sites and site networks
- Data flows
- Industry efforts in the space
- Ethical considerations for patients around DCTs
- Isaac Rodriguez-Chavez, PhD, MHSc, MSc - CEO & Principal Independent Consultant, 4Biosolutions Consulting Scientific, Clinical, Regulatory Affairs and Digital Health Technologies Co-Chair, IEEE-SA, Clinical Trial Technology Modernization Network (CTTMN)
- Jane Myles - Program Director, Decentralized Trial & Research Alliance (DTRA)
- Queen Adaugo Ohandjo - Patient Advocate and Consultant, Proof Clinical Research
- Ashley Pachter - Program Director, TransCelerate BioPharma Inc.
The ability to find, recruit, and enroll participants in clinical research remains a top challenge for trial sponsors and research sites, resulting in delayed timelines, inefficiencies, and missed opportunities. Sites consistently under-enroll and approximately half of clinical trial sites struggle to enroll a single participant. Amidst these challenges, the question arises: what is the path forward? In this session, Erica Prowisor, Senior Vice President of Patient and Provider Networks at Science 37, will discuss insights on the pitfalls of traditional patient recruitment methods, and share a simplified approach to patient recruitment that has the potential to dramatically improve performance.
- Erica Prowisor - Senior Vice President of Patient and Provider Networks, Science37
- Lee Levin - Partnerships Lead, Tech, Consumer, and Digital Products, Digital Medicine Society (DiMe)
- Case study
- Data collection, acquisition and processing
- Charmaine Demanuele - Executive Director, Head of Quantitative Sciences for Digital Sciences & Translational Imaging, Pfizer
While the industry and regulators’ interest in decentralized clinical trials (DCTs) is long-standing, the Covid-19 pandemic accelerated and broadened the adoption and experience with these trials. The key idea in decentralization is bringing the clinical trial design, typically on-site, closer to the patient’s experience (on-site or off-site). Thus, potential benefits of DCTs include reducing the burden of participation in trials, broadening access to a more diverse population, or using innovative endpoints collected off-site. This paper helps researchers to carefully evaluate the added value and the implications of DCTs beyond the operational aspects of their implementation. The proposed approach is to use the ICH E9(R1) estimand framework to guide the strategic decisions around each decentralization component. Furthermore, the framework can guide the process for clinical trialists to systematically consider the implications of decentralization, in turn, for each attribute of the estimand. We illustrate the use of this approach with a fully DCT case study and show that the proposed systematic process can uncover the scientific opportunities, assumptions and potential risks associated with a possible use of decentralization components in the design of a trial. This process can also highlight the benefits of specifying estimand attributes in a granular way. Thus, we demonstrate that bringing a decentralization component into the design will not only impact estimators and estimation but can also correspond to addressing more granular questions, thereby uncovering new target estimands.
- Alex Sverdlov - Senior Director, Statistical Scientist, Novartis
- Alyssa Beck - Manager of Sales Operations, 1nHealth
- Case study
- Arthur Combs - President, FutureTech Strategies, Inc.
a. What does the relationship look like for technology methods i.e. home health
b. If sponsors/CROs are deploying a vendor for home health how would that interconnect with the sites
- Jimmy Bechtel - Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)
a. Case study
- Len Rosenberg, Ph.D. - Head, Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society