Future Trials Conference: Decentralized, Direct-to-Patient & Virtual Clinical Trials

• Letting no crisis go to waste: lessons learned from COVID-19 and how to reduce the burden on patients
• Ensuring your decentralised trial is patient focused, accessible and inclusive
• With so much rapid change in the past year, what further steps do we need to take to make trials more accessible for patients?
• Increasing patient involvement in study design: how to ensure patients are consulted throughout the process

• The impact of harmonizing data for better outcomes
• Centralizing real-world data and developing new digital biomarkers
• Deploying consumer design principles for a better participant experience

• Assessing the short, medium and long term impact of COVID-19 on clinical trials
• Beyond just crisis management: what is next for virtual, remote and decentralised clinical trials?
• Lessons learned from COVID-19 and how experience can be used in the future
• Incorporating decentralisation into clinical trial protocols
• Moving forward in a highly regulated area: where are regulations going in terms of conducting clinical trials remotely?
• Has COVID-19 marked an end for the need for regular site visits throughout a clinical trial, or should we be looking at hybrid models for the future?

MODERATOR:

Anka Ehrhardt, Science Director, Clinical Research, CHDI Foundation

PANELLISTS:

Aman Thukral, Head of Digital Operations and Clinical Systems, AbbVie

Greg Tuyteleers, Global Operations Head, Managed Access, Global Lead Trial Virtualisation, Janssen R&D

Eduardo Oliveira, Global Monitoring and Site Engagement, Global Clinical Operations, Development, R&D, GSK

Jeremy R. Price, Director, Clinical Innovation & Strategic Partnerships, Pfizer

Melaina Boyce, Director, Clinical Innovation, EMD Serono, a business of Merck KGaA

Stephanie Kallay, Director, Patient Advocacy and Outreach, Crinetics Pharmaceuticals

• Accelerating decentralized clinical trials through effective uses of EHRs/healthcare data
• Overcoming regulatory, privacy, and human challenges around the use of healthcare data for decentralized clinical trials
• Realizing the importance of technology to streamline the overall clinical research workflow

Join us for a round table discussion with a patient advocate who will answer questions including:

• Why would a patient want to participate in a virtual trial?
• Do you need to be tech savvy to participate in a clinical trial?
• How does the efficiency of a trial process benefit a patient?
• What are the benefits of having drugs delivered to the patient’s home?

• Practical examples of changing our trial model: what we did, and what we would have done differently
• Logistical hurdles created by decentralised models and how to overcome these
• How have patients responded?
• Incorporating flexibility into trial protocols

To ensure the success of your clinical trials, institutions need to understand and use these new technologies to optimize site selection and feasibility.

• Difference between EMR and claims data
• Using claims data for clinical trial recruitment to narrow down target demographics
• Applying real-world data to accelerate protocol modeling, site selection, and feasibility
• Achieving diversity in clinical trials

As the world’s first Virtual Research Organization (VRO), founded in 2017, ObvioHealth has helped to shape present-day decentralized research. With 4+ years of experience designing, conducting, and monitoring more than 35 fully virtual or hybrid studies across 28 countries and 16 therapeutic areas, we have learned a lot. Our presentation will walk you through the virtual clinical trial experience, from study design and recruitment though outcomes measurement to data analysis and visualization. We’ll share real world examples to illustrate how modern innovations like wearables and sensors can deliver more efficient trials and better data.

• Questioning your approach to study planning
• Building study execution around your technology
• Module highlights: eTMF and randomization and trial supply management

• Ensuring instructions are clear and easy to use: the importance of communication with patients
• Navigating regulatory affairs when delivering drugs directly to patients in their homes
• Emerging technologies to make direct-to-patient shipping easier in a post-COVID-19 world

• Increase site activation and shorten enrollment timelines
• Broaden site footprints with remote data capture
• Reduce site and patient burden using eSource data

• The vital and changing role of sites in hybrid and decentralized clinical trials
• Areas for site readiness in study delivery
• Need for industry collaboration in supporting site readiness

• Implementing a DTP strategy that works for your study
• Analysing the benefits and advantages of DTP for sponsors, sites and patients
• Developing a patient centric approach: DTP as a way to increase patient recruitment and retention
• Using DTP to optimize supply chain flexibility
• Ensuring information is clear, concise and that instructions are easy to follow when using DTP distribution and conducting trials remotely

MODERATOR:

Ahmad Namvargolian, Chief Executive Officer, Care Access

PANELLISTS:

David Larwood, President and CEO, Valley Fever Solutions

Laurie Berry, Development Scientist, Pfizer

Catherynne Cruz-Sheckner, Director, Clinical Supplies, Ionis Pharmaceuticals

Prasun Mishra, Chief Executive Officer, Agility Pharmaceuticals

Amanda Nite, Director, Product Management, Rave RTSM, Medidata

During this session, we’ll explore how a DCT approach can enable:

• An extraordinarily efficient method for longer duration, real-world studies such as those for labeling changes, registries, long-term follow up, pharmacovigilance, outcomes research and pharmacoeconomic studies.
• Trial sponsors and CROs conducting these low-touch, resource-heavy studies can reduce start-up time, accelerate enrollment, and obtain a patient cohort more representative of the target population.
• Granular clinical data gleaned from DCT tools and technologies can be used alongside other real-world data to create custom-curated longitudinal datasets to help answer a wide range of research questions.

• Challenges of clinical research for rare diseases
• Opportunities and challenges around recruitment: how to ensure studies are as accessible as possible to patients with rare diseases
• Is retention and trial completion easier in a decentralized model?
• Home nursing options where complete remote monitoring is not possible
• Collecting data remotely and navigating hurdles around data and evidence for a study with a smaller number of patients

• Describe an ecosystem based approach to that manages risk while harmonizing provider technology and workflows
• Define a trial technology plan to create a clinical data mesh that allows for the dynamic surfacing of the optimal for sites and subjects
• Outline the essential elements of integration methods that are accessible and sustainable internally and across organizations
• Share lessons learned from the trial design, conduct, and completion of hyper-integrated full eSource trials

• Moving to a continuous vs visit-centric monitoring process
• Writing a monitoring plan that includes remote and in-person activities
• Aligning best practices with study site personnel
• Using televisits to increase interaction with investigators
• Documenting remote monitoring activities

• Explaining the benefits of site-to subject shipping over depot-subject shipping from a regulatory stance
• Introducing new technology options to facilitate home-based treatments, including real-time, temperature-controlled products for remote monitoring
• Exploring the benefits that incorporating digital strategies into the Direct-to-Patient model bring, through mobile health, telehealth, and virtual platforms

• Building the company internal virtual trial eco-system is key to make virtual/decentralised trials happen
• “Perfect” is the worst enemy of “feasible” – hybrid models may be superior to 100% virtualized
• Some elements of virtual trial may need substantial and disproportional investments (e.g. digital biomarkers) for trial to be fully virtual
• Virtual trial also reaches beyond mere execution – with value to be obtained from design, planning and monitoring through digitalized business tools and processes

• From theory to practice: why virtual site monitoring was developed and its impact on global monitoring
• How virtual site monitoring works: the ultimate virtual site tour with remote live video and guided documentation
• Common uses of virtual site monitoring: pre-site selection, site initiation, interim monitoring, home health, site closeout, and supplier audits
• Real-world examples and early findings in site selection and home health studies

• Ensuring all technology is GCP compliant
• Creating flexibility for patients: will hybrid trials be the future of clinical trials, rather than fully decentralised trials?
• The impact of emerging technologies on patient engagement throughout the trial process
• Creating a data driven approach to make trials more efficient

• Motivation for clinical biomarkers (use case)
• Technical expectations for a clinical biomarker
• Case study evaluating a fully validated assay for trial utility

• Opportunities that decentralized clinical trial options offer to make studies more inclusive
• How making studies more inclusive can lead to reducing clinical trial costs
• What costs can realistically be reduced by conducting decentralized global studies versus site-based studies