Implementing decentralized/hybrid clinical trials through interaction between all stakeholders

Panel discussion

Implementing decentralized/hybrid clinical trials through interaction between all stakeholders

In 2020, COVID-19 and the associated lockdowns had a huge impact on how clinical trials were being run across the world. One result of that was a rapid increase in the implementation of decentralized or hybrid trials. With patients unable to come visit study centres in many cases, this was initially forced on many, but the hope is that it will become a long term strategy to improve how studies are run.

With such a radical change to the way that studies work, it is essential that all stakeholders involved are on board and working together to make it succeed. One of the highlights of Clinical Trials Europe Virtual 2020, was a live panel of leading industry experts discussing the interaction between all stakeholders on decentralized trials, followed by an Q&A with the audience.

The panel includes:

Maria Kuthning, Executive Global Clinical Operations - Digital Transformation, Formerly Johnson & Johnson, Germany
Birgitte Denlowm GCP Advisor Specialist, Global Clinical Quality & Intelligence, Novo Nordisk, Denmark
Jennifer Goldsack, Executive Director, Digital Medicine Society (DiMe), USA
Matthew Bonam, Head of R&D Digital, AstraZeneca R&D
Zach Hales, Product Manager (US), Greenphire, USA
Rasmus Hogreffe, VP, Decentralized Clinical Trial Innovation, Medable, USA
Ahmed Albaiti, CEO and Founder, Medullan, USA

You can watch the full session on the next page.

Moderated by Maria Kuthning, formerly Executive of Global Clinical Operations - Digital Transformation at Johnson & Johnson, the panel discussed the roles that pharma, doctors, patients and regulators all have. For pharma there are questions over how to include patients in the study protocol development, reducing the number of visits and focussing on necessary endpoints to only collect data that you need. Doctors and nurses on the frontline, running the trials, have to adapt their ways of working being linked to a patient just via a screen and adapting their reporting. What training is needed and how can knowledge be shared. Patients also need to be comfortable with the study and ensuring they are educated on the process and the use of sensor technology.

One of the main challenges with implementing decentralized trials is meeting regulatory requirements, so the panel discusses how regulators can support the new decentralized trial setting. There are questions over data privacy, shipment and home nursing to name just a few. Equally, what can industry do to better share knowledge from pilots with regulators.