“In a time where COVID-19 has taken its toll across many sectors and industries, including the clinical trial industry, the need for rethinking the way clinical trials can be conducted has become increasingly clear!” says Anders Daniel Andersen, Head of Medical Sciences & Safety at Studies&Me, a LEO Innovation Lab spin out, when asked about what positive outcomes there have been with the pandemic.
He continues: “Novel methodologies and approaches, such as digitizing more elements of clinical trial conduct, are rapidly gaining ground. There is now an openness and willingness across the entire clinical trial value chain, from the patients to the regulators, to adapt much faster than we initially had anticipated.”
Anders Daniel Andersen, Studies&Me
For a company like Studies&Me this adaption speed has had a big impact, as they are a virtual contract research organisation established to set new standards for clinical research.
“In Studies&Me we have been working with digitizing clinical trials for some years now. The pandemic has given us some tailwind and accelerated buy-in on the concept of decentralising clinical trials.”
Examples are how they are in dialogue with both The United States Food and Drug Administration (FDA) and the Danish Medicines Agency (DKMA) about
- How they can develop tools to assess efficacy and safety remotely.
- How to ensure that decentralised clinical trials comply with the standards of good clinical practices.
“We believe that in some clinical trials, there is a possibility to make patients less dependent on physically showing up at the clinic or the lab. Arguably this could reduce some barriers for participating in clinical trials, as patients would no longer need to travel to the sites so often but can simply do some of the trial related activities virtually. Furthermore, there is a benefit of preparing the clinical trial model to be more resistant towards future pandemics – should they come.”
Preparing for what comes next is difficult but necessary. What positive outcomes have you seen from the pandemic and what do you expect will be the next new normal?
Please share with us via the post on our social media channels.