DAY TWO: 17TH April 2024 - EST/EDT (Eastern Daylight, GMT-4)
DAY TWO: 17TH April 2024 - EST/EDT (Eastern Daylight, GMT-4)
- 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. Case study
- Alekhya Pochiraju - Product Development Global Operations, Genentech
- Observational studies
- DCTs
- Generative AI
- Doug Foster - Partner, Advanced Data Sciences
a. Case study
b. How are models for clinical studies changing in the US to involve regional/ specific pharmacies as research sites?
c. How does this link to remote/ DCTs?
d. Why isn’t this happening in the EU?
e. Is this an approach that we should keep persuing?
f. What is the role of ‘healthcare providers’ supporting routine care in trials?
- Joseph O'Rourke - Head, Commercial Development, Walgreens Clinical Trials
- Mike Andino - Sr. Director, ICON Patient Recruitment & Retention, ICON plc
We will explore the delicate balance between innovation and security in the realm of Digitally Connected Trials. DCT brings unprecedented innovation to the field of clinical trials by leveraging digital tools such as wearables, mobile applications, and remote monitoring devices. However, having too much of an un-regulated setup can lead to regulatory issues and dissatisfaction amongst partners and consumers.
Here are a few that we will explore:
- Is the innovation worth the ROI? Reusability of a technology vs “Shiny New Object”
- What level of data security is mandatory? The increasing reliance on digital platforms introduces vulnerabilities that can be exploited by malicious actors.
- Operationalizing: are all the right people involved in decisions (sponsor, CRO, Sites, and Patients)?
- Nimish Patel - Principal Systems Operation Manager, Genentech
a. Case study
b. Importance of Full/Hybrid DCT models when working in a rural infrastructure
c. How do you ensure reliability of data & SOPs to effectively run the trial?
d. How do rural areas cope with the use of technology in trials?
e. What issues does this cause with regards to retention?
- Becky Kiesow - Clinical Research Project Manager, Billings Clinic
- Jamie M. Nelson - Research Scientist, Collaborative Science & Innovation Department, Billings Clinic
To understand the current state and future direction of decentralized clinical trials post-COVID-19, a survey was conducted across 14 sponsor companies to assess implementation experiences, success factors, and challenges in global clinical trials. This presentation will focus on key trends and insights across survey respondents, including lessons learned. Findings reveal that most trials that offer these modalities are not fully decentralized but hybrid in nature – based on regional acceptance, patient preference and protocol design. While implementation challenges remain, ongoing collaboration among industry, regulatory authorities, and patients will play a pivotal role in shaping the future landscape of decentralized clinical trials.
- Katie Madden - Director of Digital Health Process Optimization, GSK
f. Mobile sites
g. Pharmacies
h. Point of Care to mobilise entire healthcare systems
i. Pop up sites- open on demand based on community needs
j. How can these different models work? Benefits and Limitations
k. What framework is required to consider implementation of these models?
l. How do companies ensure quality and oversight when looking at alternative models?
m. How efficient are these new models?
- Jimmy Bechtel - Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)
- Joseph O'Rourke - Head, Commercial Development, Walgreens Clinical Trials
- Becky Kiesow - Clinical Research Project Manager, Billings Clinic
- Jamie M. Nelson - Research Scientist, Collaborative Science & Innovation Department, Billings Clinic
- Gerald E. Finken - CEO, RxE2
- Arthur Combs - President, FutureTech Strategies, Inc.
- Paediatrics
- CRS
- Katerina Placek - Senior Manager - Digital Health Sciences, Takeda
- Sarah Valentine - Partnerships Lead, Life Sciences, Digital Medicine Society (DiMe)
a. Are reg agencies supporting DCTs, and if so how?
b. APAC, EMA, UK & US perspective
c. Do decentralised and hybrid trials not only lend themselves to diverse patient populations but also diverse demographics?
- Masahiro Wanikawa - Clinical Evaluation Expert Committee, Drug Evaluation Committee, DCT Task Force, Chugai Pharmaceutical Co. Ltd.
a. How are companies capturing data from patients: ePRO, eCOA or Device?
b. What are organisations doing around data management?
- Guang Liang-Wang - Head of Data Management, Cerevel Therapeutics, LLC
d. Case Study
- Lee Levin - Partnerships Lead, Tech, Consumer, and Digital Products, Digital Medicine Society (DiMe)
- Tom Brazier - Director, Decentralized Clinical Solutions, mdgroup