ARTIFICIAL INTELLIGENCE


trials as they can see the benefit of the trial overcoming the dangers of data loss.


How are the regulators reacting to the use of AI in decentralised trials? Regulators have been stepping up to understand that AI is the future, and we have seen more regulations coming through since 2019 within the European Medicines Agency, Food and Drug Administration and other regulatory bodies. Many countries are publishing road maps and guides to these types of trials.


What would be the main issues if a company failed to adopt AI and what would be the main impacts on them moving into the future? I think they will be late in the race, because every large pharma company is developing their AI capabilities and launching projects in this area. It is helping them to foster more effective drug development and bring medicines to patients sooner. AI can reduce the cost of a trial as well: this is a huge motivating factor behind adoption. We are starting to see drugs developed through the use of AI coming to market and these trials are being used more widely. If companies don’t start looking into these technologies, they might start coming more slowly to the development of drugs, leaving them behind in the race. There is also timelines to consider: it has been shown that implementing AI and DCT might reduce the time it takes to trial a drug by at least five to six years.


Lastly, what would be your advice to a company that is just starting on its AI or decentralised trials journey? What would be the best or the most realistic first steps for them to take? What I always recommend is that you can’t think straight away of implementing AI in a complete way as an end-to-end solution. You have to think: what is your molecule? What is your therapeutic area? And what is your budget in cost? This is very important because some companies could step too far ahead too soon and implement expensive AI systems before they are ready. Therefore I recommend that you see where you want to implement your AI and DCT within your unique trial design. Most companies are doing it as part of a hybrid model – if you think there are some processes that can be done digitally then you can introduce them, but you should always weigh the options and consider the costs. There are so many points here to consider


before you implement AI or decentralised trials in your project, so you should first select whether you really want this and, if so, which area will you implement it in? Think as well on how are you going to use DCTs: who are the vendors you will use? Which countries are you going to go to? Do they have the establishment in their country? So there are all these parameters to consider before we really prepare the protocol on using AI as part of a decentralised trial.


Outsourcing in Clinical Trials Handbook | 87


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