Patient engagement in R&D Clinical Trials
- Discussing the personal experiences of the patient
- Understanding the patient’s perspective
- Defining 'patient centricity'
Advantages and utilization of Hybrid Clinical Trial Designs
- Preserving the benefit of randomization and providing real-world outcome data
- Accelerating product development.
- The hybrid approach to lower the cost of data collection and patient follow-up.
- Incorporating hybrid & decentralised trials as a potential solution to decreased patient enrolment
How to how to optimize collaboration with Patient Advocates and Patient Organizations
The Accelerating Clinical Trials in the European Union (ACT EU)
Better, faster, optimised clinical trials in Europe!
This initiative will Improve the clinical trials environment in the European Union through harmonisation, innovation and collaboration with stakeholders.
Impact of external factors beyond our control: How pharma and biotech companies in Europe can mitigate against this
- Analysing Global conflicts impact on clinical trials.
- Discussing the multitude of external factors; the possibilities of severe weather impact, healthcare emergencies etc.
- Addressing logistical challenges
- Assessing future trial design from a more resilient perspective
This session will outline ACT EU plan to coordinate stakeholders, regulators and ethics committees leading to more cross-border collaboration., resulting in better, more impactful clinical trials, benefitting patients and healthcare in Europe in the process
Strategies for Site Selection; enhancing one’s knowledgebase for the best move forward
- Robust feasibility for clinical trials; from protocol design to site selection
- Access to sites and site selection within Europe
Developing Data-Driven Decision Making in Clinical Research; faster, cheaper, safer
- Building a robust data infrastructure
- Utilising innovative technologies
- Adhering to privacy and data security regulations
- Analysing whether to choose a full-service provider or a network of providers, is there any rational behind this decision making
- Looking into the driving force of site selection; finances, talent, internal resources, competing studies at sites, investigator interests
Think Tank: How to best promote and raise funding for your study
Enforcing data governance principles
FIRESIDE CHAT
The rising cost of Site Spent & shortage of personnel, the paradox!
- Examining the challenge with site personnel recruitment & considering all solutions to reduce burden and expenditure.
- CRO’s providing clinical research personnel: Is it really helping, or is this a short-term benefit, creating a long term issue?
- The blame game; Government, Pharma industry, CRO’s
A peek into Big Data: Using Real World Data in your clinical development program
- How real-world data can inform clinical trial planning
- Highlights of regulatory guidelines for the use of real-world data in clinical development
- How can real-world data add value in the clinical development process
Navigating the challenges of the Clinical Trials Information System (CTIS)
- Implementation of CTIS in order to manage and control your clinical trial data
- Delving into CTR timelines within the CTIS System and how to control this.
- Underling the challenge with a mandatory 24hr response time for Safety Questions, suggestions to manage this.
Edward Walsh, Senior Director, Regional Clinical Trial Operations Europe, Seagen
Protecting Our Planet: Sustainability in clinical trials
- Understanding the environmental and social impacts of clinical trials
- Discover how some often-overlooked parameters can have a significant impact on waste reduction and how to manage this
- Identifying materials that are typically printed that could be provided digitally to contribute to sustainability
- The impact of cross-department collaboration
- Sustainability by design: innovation and changing behaviours, focusing
PANEL DISCUSSION - “Clinical Research is Moving to Asia Pacific” Uncovering what Europe can do to ensure we do not fall behind in our Global standing. Regulatory & Clinical perspectives.
- Uncovering why there is a huge increase in Asia Pacific Clinical Trials; Our numbers are that of 10 years ago whereas Asia Pacific is on an upward trajectory.
- Application to approval time getting longer; are we losing our competitive edge!? Addressing the ease and speed to conduct trials overseas.
- Addressing the number of trials also moving to the US, in particular, early phase studies
- Exploring motivation techniques for clinical research in Europe
- Discovering maintenance and growth of research delivery
Implementing and Integrating AI & Machine Learning into Clinical Operations & Drug Discovery
- Strategies to enable change and support the transition
- Navigating machine learning in your clinical trial design
- Lessons learnt
Exploring possible solutions
FIRESIDE CHAT - Focusing on the importance of Diversity & Inclusion in clinical trials
Diversity matters because inclusion, trust and equity matter in healthcare. When developing therapies and medications, pharmaceutical and life sciences companies are tasked with designing products for a diverse range of patients and care providers. We will be discussing how to ensure diversity in clinical trials, for the future of global health.
- Building Strategic Partnerships
- Leveraging Data and Digital
- Remodeling processes & tools
Moderator: Amelia Hursey, Research Manager, Parkinson's Europe