DIA 2024: Rob DiCicco of TransCelerate Biopharma Discusses the State of AI in Clinical Research

ACT: What do you think are some of the greatest opportunities for integrating artificial intelligence (AI) into clinical research?

DiCicco: I think there are a couple of different ways to look at it. One is from the pharma R&D perspective, and the other is from the site and patient perspective, and then you have other stakeholders as well, such as regulators, health authorities, and so forth. I like to think a lot about the patient-facing opportunities, because some of these are already being embedded in clinical practice; things like scheduling and things like chat bots to help a patient through their journey and answer questions for them. I think those are opportunities are happening in the healthcare space that we can migrate into the research space as well.

On the pharma R&D side, there are a variety of different opportunities to help the humans, right? I tend to think about those opportunities for augmented intelligence more so than artificial intelligence. Those areas where there are repetitive tasks; document creation, migration of data, or connecting data in a variety of different systems that may not be connected, and finding solutions to accommodate that, I think those are the opportunities, because pharma R&D and clinical research is becoming more and more data driven every day.

ACT: How are the regulators viewing the integration of AI? Are there any challenges there?

DiCicco: I always try to be careful to say that I'm not speaking on behalf of the regulators or putting any kind of words in their mouth, but I think they're embracing it. I think they appreciate that, one, there's a tremendous opportunity, and they want to get safe and effective medicines on the market quickly as well. I think there's an opportunity for it to not only help in their day-to-day jobs, but I think they understand that this is a way of the future, and even the EMA and the FDA have put out papers that constituents and stakeholders can take a look at and see how they're starting to think about it.

I think when new technology comes out, we tend to sometimes think that they're very, very different, or the core bits of what we do in terms of assuring quality and ensuring accuracy, and those kinds of things are somehow perturbed. I think a lot of that groundwork is laid, but clearly we have a lot to do to educate ourselves and to use AI responsibly so that we understand that and I think when you bring up the regulators, the thing that will be challenging to the regulators is the thing that's challenging to everybody. There are some AI companies that are very, very transparent around how they're making predictions. They publish on it. They publish the math behind it. They may not show you the code, they may not let you have the raw data, but they're very transparent. It's not black box. They let you look under the hood a little bit. And there are other companies where it's not. I think there has to be massive transparency if we're going to implement it in our day-to-day jobs, and use it for decision making, and use it in some of the processes that we do in terms of pharma R&D, and that covers not just regulators, but all the stakeholders. They have to have that transparency.

ACT: Where do you think the use of AI in clinical research will be in five years?

DiCicco: I think you'll see a lot of new job training and job opportunities as a function of that. I think pharma companies will find partners to work with. I think there will be a lot more opportunity to leverage the data that we collect, which is challenging currently. Whether that means interpreting new kinds of signals and new kinds of endpoints, whether that means just the way we aggregate data, I think it will enable a lot in the area of being able to get insights and so forth. I think you'll see some processes that are repetitive like document creation, file creation, those kinds of things move on. But I think what I'm really, really hopeful for is to see how it gets embedded, in terms of supporting a patient journey, supporting site staff in terms of the things that they don't have time to do to give them more times to interact with patients.