CONTEXT:  A teaser article for the DIA 2021 where discussions are expected around decentralised trials  and accelerated approval pathways.  The DIA has always a great place for the industry to discuss the weighty topics and move things forward as the DIA itself is not associated with any stakeholder groups.  As their CEO says, “We have no pony in the race…. Most importantly, we are an organisation that attracts the decision makers and that is what makes the meeting so critical.”  

IMPACT:  Medium

READ TIME:  2 mins

Quality Level Mean [1 – 10]:  7

1. ““And this has led to a huge amount of work across stakeholder groups on this issue of decentralized and digitized trials that includes topics that DIA has had in its wheelhouse for well over 15 years such as data science and the use of real world evidence, getting the consumer and patient involved in the clinical trial process more overtly, etc.”. And because the DIA organization is neutral, and because it is not associated with any stakeholder groups, its annual event enables the healthcare community to advance the discussion around critical issues, whether that is the greater adoption of decentralized clinical trials or other common challenges, stressed the CEO.” 

2. ““The topic of modernizing the whole clinical infrastructure and process has been [on the radar] for many, many years but the pandemic of course made us think about things in a different way, because we had to,” said Barbara Lopez Kunz, global chief executive, DIA.” 

3. “DIA has been ahead of the game on the issue of clinical trial modernization, though, having developed and provided a sharing and learning opportunity early last year around that topic, said Lopez Kunz.” 

4. “Having that broad continuum of industry leaders and decision makers at the upcoming DIA meeting all focused on the key topic of the modernization of clinical trials is going to be momentous, she added.” 

5. “Then we also have an entire session dedicated to the perspective of the US Food and Drug Administration (FDA) on clinical trial modernization, and I think that is going to be a really interesting way of hearing about how it and other regulators are working to integrate, streamline and standardize the use of digital health technologies in trials.” 

Source URL: https://www.biopharma-reporter.com/Article/2021/06/16/DIA-2021-set-to-shed-some-light-on-decentralized-trials-process-accelerated-approval-pathways