As COVID-19 continues to spread and countries restrict movement, the impact on clinical trials is unmistakable. New studies are being delayed, and patients already enrolled in trials are facing challenges making their scheduled visits. Sponsors and CROs are trying to assess the impact on their studies, mitigate risk and develop recovery plans. This webinar will address key considerations for managing clinical trials during these turbulent times and will highlight how industry-wide trial metrics and analytics can support:

• Real-time situation insights by geography and therapeutic area
• Impact assessments at trial and portfolio level
• Identification of leading indicators of slowdown and recovery

Speaker:

Rachel Horovitz
Senior Director, Product Strategy, Acorn AI
Medidata, a Dassault Systèmes Company

• When a vaccine leaves the laboratory, its fate is determined by society rather than science
• Bringing society into the laboratory will help to achieve acceptability
• Compare the management of polio vaccine research and measles vaccine research in terms of public engagement
• Ebola and SARS show the importance of sustaining investment – but Ebola, in particular, underlines the risks of neglecting the social aspects of epidemic disease
• All disease outbreaks are accompanied by outbreaks of fear, moralization and action.
• How can you design vaccines to avoid provoking or amplifying fears?
• Culturally accept contents
• Avoid possible lay connections with ‘scary substances’
• Avoid ‘deficit thinking’ about the intended recipients of the vaccine

Speaker:

Professor Robert Dingwall
Professor of Sociology
Nottingham Trent University

Attend this session to learn how you can increase the number of users and the volume of clinical data while still maintaining compliance and performance with Accel. Presenters will cover the following topics:

• Outsourcing validation & compliance within CDSIC & GxP guidelines
• Storage options that allow increased data variety & volumes on-demand
• How to manage global users & system consolidation during an expansion period

Speakers:

Phil Loucks
Client Manager
Accel

Ali Dootson
Director, Consulting
Accel

Mark Jones
IT Manager
Veramed

Nate Bennett
Head of Stats, Standards & Innovations
UCB

Over this 45 minute webinar, MRN will explain the community trial model, giving you insight into what is changing in the sector, how the community model is operationalised and what might continue to change moving forward. MRN will give you information on: the key challenges in today’s clinical trial environment; how the community trial model addresses those; and how success of this model can drive patient engagement in clinical trials.

Speaker:

Stuart Redding
Chief Operating Officer
MRN

This webinar will provide practical examples on how to involve children in clinical trials.

A child-friendly approach is necessary not only in the daily clinical practice, but throughout the research and development process, from setting research priorities, involvement in research design and planning, research conduct through to dissemination and communicating research findings. In case of studies involving children, age-tailored information booklets, assent forms and summaries of the results should be written in age appropriate, simple and understandable language to ensure ease of reading for parents and children. Moreover, the investigators should obtain agreement from the child in addition to informed consent of the parents, even when this agreement is not mandatory by law.

Speaker:

Mariangela Lupo
Communication and Patient Advocacy Manager
TEDDY European Network of Excellence for Paediatric Clinical Research

Sharing the ways in which Parkinson's UK engages with the research community. Initiatives for increasing participation, research involvement and improving trial retention.

Speaker:

Amelia Hursey
Research Participation Lead
Parkinson's UK

Find out the answer to your most pressing questions like:

• How do we keep patients and clinicians safe?
• What critical data is needed to ensure patient safety?
• How will patients get their devices?
• Will sites be able to change?

Speaker:

Gillian Livock
Head of Strategic Partnerships
Medable

Dr. Michelle Longmire
CEO, and Co-founder
Medable

Amid the wake of COVID-19, there is an anticipated but significant increase in demand for virtual or hybrid trials with remote/centralized site monitoring and patient enablement services. With sites increasingly proving to be inaccessible across the globe for patients, site staff, and/or site monitors, and regulators halting inspections, the biopharma industry is facing many new challenges to ensure patient safety, consent, compliance, and data quality and integrity. Concurrently, life science stakeholders must come together to join the global effort of driving healthcare forward.
This session will highlight how digitally connecting previously siloed people, applications, and departments enable a seamless trial management experience with a virtual or hybrid model that enables eConsent, remote monitoring, and enhanced randomization. Combining real world experiences with actionable insights that speed time to market, and offer patients a safe, de-centralized experience that is safe for caregivers and patients alike is central to the discussion of the optimal patient experience.

Speaker:

MaryAnne Rizk, PhD
Senior Vice President, R&D Digital Strategy
IQVIA

This session will address technology enabled clinical trials, the value of this approach, and the considerations involved in ensuring that measurements made by technologies are reliable. Approaches to decentralizing the conduct of clinical trials will be discussed, touching on oversight, safety and inspections. Illustrative examples will be presented.

Speaker:

Dr Leonard Sacks
Associate Director for Clinical Methodology, Office of Medical Policy, Center for Drug Evaluation and Research
Food and Drug Administration

Successful implementation and use of patient-facing digital technologies (PT) in clinical trials requires collaborative effort and input from key stakeholders including sponsors, clinical research sites, patients and technology vendors. Despite this, there is often an unequal distribution of voices during the process of PT implementation, with patients, clinical research sites and vendors failing to always be heard. The TransCelerate Patient Technology initiative set out to engage all three stakeholders to better understand successful ways of working during the implementation of PT in clinical trials. The result is the Patient Technology Toolkit, which contains guidance, considerations and best practices for utilization by sponsors, clinical research sites and vendors. Attendees will learn about the proposed approaches for utilizing patient, vendor and site input into the design and implementation of clinical trials with patient technology. Primary research from conversations with patients, sites and vendors as well as the resulting tools for industry will be shared and discussed.

Speaker:

Alison Bond
Director, Global Regulatory Policy & Intelligence
Janssen