DAY TWO: 17TH April 2024 - EST/EDT (Eastern Daylight, GMT-4)
DAY TWO: 17TH April 2024 - EST/EDT (Eastern Daylight, GMT-4)
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?
- Kendal Whitlock - Head of Digital Optimization, RWE Clinical Trials, Walgreens Boots Alliance (pending final confirmation)
a. Patient centricity doesn’t always equal site centricity
b. What patient centric approaches create the greatest burden for sites
- Home health
- Wearables
- Home nursing etc.
c. How can we make this more balanced so all parties benefit?
d. Site engagement and improving ROI for patients and sites
e. Ways to balance the patient/ site burden or clinical study burden in general.
- Isaac Rodriguez-Chavez, PhD, MHSc, MSc - Senior Vice President, Scientific & Clinical Affairs, Global Center of Excellence for Decentralized Clinical Trials, PRA Health Sciences
- Using RWD for reg and related purposes
- Sample size/ number of data sources
- Case study
- Ankeet Bhatt - Brigham and Women’s Hospital, Harvard Medical School
- Case study
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. Besel - Research Nurse Scientist, Institutional Review Board Liaison, Privacy & Exemption Committee – Chair, Robert Wood Johnson Foundation Future of Nursing Scholar, Collaborative Science & Innovation Team (CSI), Billings Clinic
a. From a sponsor perspective, how many sites are already set up and ready to conduct DCTs?
b. Would sponsors risk running a DCT with a site that is experienced in traditional CTs but less so DCT?
c. Quality measures to ensure success- so more of a partnership
d. How do novel models affect site selection?
e. How should sponsors be engaging with sites?
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)
a. How can AI play a role in the collection of data?
b. When looking at integration and data from multiple sources what considerations need to be made around quality and consistency?
c. How do organizations ensure quality?
c. Is AI well placed to act as a data management tool?
d. Uses to optimise collected data
e. What are the limitations or the technology?
f. Why is the hesitation when considering it?
- What are the multiple uses of AI in the clinical space?
- How can the use of AI be optimised in Full/Hybrid DCTs?
- What is AI and where has it seen the most success in the clinic
- Start-up and feasibility
- Patient recruitment
- Maintenance/ Operations
- Automation etc
a. Case study
- Alekhya Pochiraju - Product Development Global Operations, Genentech
a. With DCT/ novel provide a platform to enroll patients who need the therapies the most
b. Designing and executing trials to put an emphasis on these patients & increase patient engagement
c. What is the balance – access to more patients, but how do you tackle patients who do not have access to infrastructure to use technology?
- What will this mean for data integrity?
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, Japan Pharmaceutical Manufacturers Association (JPMA), DCT Task Force, Chugai Pharmaceutical Co. Ltd. & DCT Task Force PMDA
a. How are companies capturing data from patients: ePRO, eCOA or Device?
b. What are organisations doing around data management?
a. Biogen Case Study
b. How can these types of implementations support clinical trials?
c. How do you decide which trials it is relevant for?
d. Case Study
- Lee Levin - Partnerships Lead, Life Sciences, Digital Medicine Society (DiMe)
Informa is looking for 3 speakers to do 10 min presentations on the application of Full/Hybrid DCTs to the one of the below therapeutic areas. We would like feedback on what the challenges have been, how the use of decentralisation was approached, and where the technology has had a positive impact on the way trials are conducted:
a. Vaccines
b. Oncology
c. Cardiology
d. Paediatrics
e. Immuno-Oncology (DiMe)
- Sarah Valentine - Partnerships Lead, Life Sciences, Digital Medicine Society (DiMe)
- Sandeep Bhat - MSE, Digital Engagement and Implementation Lead Digital, Analytics, and Performance | Digital Operations and Process Optimization, R&D, Global Clinical Operations, GSK (pending final confirmation)
- Cost analysis for novel tech to be used by sites.
- Site perspective on integration and interoperability of technology systems
- What are the data backed opinions from sites on tech implementation and working with sponsors?
a. Case study