DIA 2021 set to shed some light on decentralized trials process, accelerated approval pathways

“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.

Along with having to develop vaccines and therapies to control a pandemic, the industry had to deal with discontinuity at different trial sites globally. "Never was there a time where I saw such incredible momentum to figure out how to just keep going,” ​remarked the CEO.

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.

“We started almost immediately, in March, when it was obvious this virus was not going to just stop at China, or Asia. We brought in people who were on the ground working to address discontinuities in clinical trials, we provided them with a platform and offered open, public access to content so that people could learn from each other. The Chinese were very active in talking about what they were doing and how they were making things work. ​

“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.”​

Gathering of industry leaders and decision makers

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.

“We have no pony in the race if you will. And that aspect is highly respected by the people in the system because it allows the conversation to be truly unbiased and trusted and the outcomes to be immediately credible and usable. ​

"Most importantly, we are an organization that attracts the decision makers and that is what makes the meeting so critical. Those relationships and the ability to be able to work real time on key problems is a really critical outcome of what we try to do.​

“Heads of regulatory agencies around the world convene at the DIA meeting, they all come because they know they can get on the stage and talk about their strategies and their outcomes.”​

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.

Courtney Granville, global associate director, research, and scientific programs, DIA, briefly outlined how the hot topic will be covered at the event.

“In the decentralized trials arena, we are going to get a lot of different perspectives. There will be a session on how COVID-19 has accelerated some of the digitalization aspect, the modernization trend. From the industry perspective, we will hear about how decentralized trials are going to play a role moving forward. 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. I do think that is going to be a really big focus of the meeting.”​

Advances in regulatory science ​

The urgency and impact of the COVID-19 pandemic also changed global drug development and regulatory processes. The need for speed to understand the virus and develop new vaccines, medicines, and therapies for patients has provided unprecedented learning opportunities and revealed how the pharma industry and the regulatory agencies can improve upon traditional processes.

What will be the DIA meeting’s take on such advances?

“One of the things we are trying to do with our conversations is go back and look at the decisions we made and figure out which elements worked, which should become a permanent part of the processes going forward, what things we need to improve upon, and, most importantly, how we maintain the momentum,” ​said Lopez Kunz.

The more recent advancements made in regulatory processes, of course, might be seen as exploiting transformation efforts undertaken to date, she said. The FDA has been working on rebuilding its data science infrastructure for the past seven years:

“I would say Japan’s Pharmaceuticals and Medical​ Devices Agency​ (PMDA) and the European Medicines Agency (EMA) have been doing the same, working on how to build real world evidence, and data, into their decision making and, so, they have been prepping for it. But I think that in a highly regulated, risky ecosystem as this is, maybe people need a little bit more motivation to move somewhat faster. ​

“But the ability of organizations to find enough talented people for all of the opportunities that are there is tough right now, and from what I hear this is an absolute priority for regulatory agencies around the world.” ​

In terms of presentations on regulatory advances at the conference, Granville noted: “There is going to be a really great session where we have the FDA, the EMA and Japan’s PMDA all coming together to talk about accelerated approval pathways in those regions, how they are similar, how they are different and how they might rely on each other.”​

Another not to be missed event at the DIA meeting will be the FDA and EMA townhall, with leaders of those organizations taking questions from the floor, she said.

Indeed the DIA meeting will also see the FDA leadership take to the stage, with representatives of all the directorates linked to small molecules, biologics, etc. talking about the evolution of the agency. There is a lot of interest internationally in the work being done by the US regulator, stressed Lopez Kunz, with it having played such a dominant role, to date, in areas such as data science, digitalization, and patient engagement.

Tackling misinformation ​

Opening the DIA meeting is a keynote talk from Ken Frazier,​ chairman and CEO of Merck. “That is going to be really compelling.”​

That will be followed by a panel featuring experts from around the world addressing another key topic in the pharma domain: misinformation and the role of the scientific community in this respect, how they can help with information dissemination and understanding.

“You can point to a lot of times in the past 18 months whereby the healthcare community could have done a better job, could have been clearer with what was going on with this pandemic, for example. And it is not like they weren’t trying to; it is just they were working with the information they had at that point in time, and that confused people. It is our responsibility to get better at communicating.​

“We are not yet out of this current pandemic. Also we need to think about how we do a better job next time, and this was talked about at the G7 summit as well. As a globe, we need to get a lot more coordinated so that we don’t allow pandemics to get so out of control. The public health community was very clear about how you control a pandemic, and what you need to​ do initially is contain it and we did a terrible job of that, and so here we are trying to treat it medically. Hopefully we will get a lot more resources put into public health systems around the world to prevent that from reoccurring,” ​added Lopez Kunz.

All the content at DIA 2021 will be available for participants to access on demand for several months after the event.