The advantages of decentralised clinical trials (DCTs) are generally recognised, especially the opportunity to make clinical trials more patient centric. Additional benefits are increasingly in evidence, such as improved patient recruitment, retention, and enhanced data quality.
Nonetheless, there is a way to go before decentralised clinical trials are the standard rather than the optional model. Not surprisingly technology and operational challenges appear to still be a stumbling block as sponsors get to grips with introducing new ways of working with sites and patients along with timeline demand in trials. The regulators familiarity and comfort with the new approaches is growing, but is their guidance enough to give sponsors the confidence to drive forward these models? What will it take for sponsors to overcome the challenges and embed decentralisation into their everyday operations and reap the promised benefits?
This Financial Times Digital Dialogue, in partnership with ICON, will bring together leaders in pharma clinical development arena to discuss their most recent experiences of DCTs, where they see the greatest issues and share some of the strategies and tactics they are exploring to deliver success in decentralised clinical trials. Speakers will also discuss how they are assessing the economic value and benefits, and the new metrics for quantifying financial returns and building the business case for making DCT the standard going forward.
- What have been the experiences of clinical/ development leaders in the last year? Where have they seen benefits and value of DCTs emerging? How are they taking account of these in decision making?
- What are the types of technology and operational challenges sponsors are experiencing – are they teething problems or too significant?
- Is regulatory guidance going far enough? Where is greater clarity needed?
- What are the key factors driving the positive fiscal impact of DCTs? What are the benefits beyond cost savings?
- What is the underlying evidence for improved financial outcomes from DCTs when compared to conventional trials? Where are the returns most compelling?
- How can economic/ financial value in DCTs be measured? exploring the emerging metrics
Executive Director, Head, Clinical Trial Accelerator Unit, Biogen
Jane Twitchen graduated with a BSc in Medical Physics from the University of Exeter, UK and commenced her career with Covance, supporting a number of trials investigating radioisotope image optimisation. Having developed a keen interest in processes and systems, she then joined SAS, where she worked in the Alliances team collaborating with partners such as PWC, McKinsey and Accenture to define and implement solutions for pharmaceutical clients. During her tenure with SAS, Jane was also sponsored to complete her MBA. She proceeded to a number of software and service providers prior to joining Biogen in 2013, initially joining the Global Regulatory Affairs Quality and Operations team and moving to Global Clinical Operations in 2015. In her current role, Jane is Executive Director, Head of Biogen’s Clinical Trial Accelerator Unit and is responsible for delivery of Biogen’s goal to decrease its study start-up cycle times by more than 15%.
Head DCT Strategy & Implementation, Clinical Operations, Bayer
Dr Angela May has 20 years of experience working in clinical research, primarily with a pharmaceutical company. She has a strong operational background with significant experience in various roles in study and programme management, including large phase 3 outcome trials. In her current role, Angela leads a group with specialist operational expertise in designing and implementing decentralised clinical trials (DCT) in interventional clinical trials, including hybrid and fully-remote approaches. Angela and her team are also working to help develop broader capabilities and infrastructure to support DCT approaches in the future.
Stephanie Manson Brown
Head of Clinical Development and Scientific Innovation, and Vice President at R&D Allergan Aesthetics at AbbVie
Dr Stephanie Manson Brown is Head of Clinical Development and Scientific Innovation, and Vice President at R&D Allergan Aesthetics at AbbVie. Her Clinical Development and Scientific Innovation team are responsible for global clinical trial development strategy for the Aesthetic Medicine portfolio, covering pharmaceuticals and device; for developing innovative endpoint evaluation tools; bringing digital science and technology solutions to R&D programmes; and driving inclusion and diversity in the generation of data that is representative of individual needs. She is co-chair of the Aesthetics Pharmaceutical Governance Board at AbbVie and is the co-founder of the Science of Aging. Prior to joining industry, Stephanie was training to be a Plastic Surgeon and is a board-certified surgeon (MRCS).
Head of Decentralised Clinical Trial Solutions, ICON
Harpreet leads the decentralised clinical trial solutions team at ICON where she is driving strategy and operational delivery to transform clinical trials, accelerating clinical trial timelines and bringing treatments to patients faster. Harpreet has over 20 years of experience in clinical research. Prior to her role at ICON she held a number of roles with increasing responsibility at IQVIA. Most recently she led the European real world evidence project management team with responsibility for P&L and client management. She also led the global epidemiology team for some time while supporting data management, biostatistics and HEOR to align business practice and embed rigour in business review processes and project oversight. When Harpreet joined IQVIA in 2001 she successfully set-up and developed the project management office, focusing on bringing best practice project management, skills training and systems process improvement to clinical trials teams and more broadly across the organisation. Harpreet is a Chemistry graduate with a BSc(hons) from the University of North London.
Donato Paolo Mancini
Pharmaceuticals Correspondent, Financial Times