DIA EUROPE 2021

The session will deal with the learnings from the Covid-19 pandemic on clinical trial design and operation in the peri and post Covid-19 period. The first talk will outline alternative concepts and learnings from the Covid-19 pandemic including aspects like virtual trials, home treatment, the use of digital endpoints or wearables and utilizing remote or virtual visits. This talk will by in large include what we need to add to a trial to make it operationally more robust. The session will then in the second talk also look into what we can simplify in terms of study design, what we can take out like number of visits, what operational elements will remain important to maintain quality and what can we skip as we have learned that it is not essential. Finally, we will have one talk, reporting the experience we made with clinical trial operations that would lead to simplifications without compromising on quality from a regulatory point of view. The session will end with a panel discussion.