Artificial intelligence (AI) has the potential to uncover valuable insights hidden in protocols and clinical study reports across the pharmaceutical industry, according to experts at the Outsourcing in Clinical Trials East Coast 2025 conference in King of Prussia.
During a panel discussion on AI in clinical research, Prasanna Rao, Chief Products and Innovation officer at Saama emphasised the importance of making protocol data available to large language models (LLMs), so tools such as ChatGPT can support informed patient decision-making.
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“Companies are very protective of clinical protocol data, and I’m not sure why,” said Rao.
“These documents are already distributed broadly, including to patients. There’s nothing particularly sensitive in them. I believe the real concern is that big pharma is nervous about AI analysing these protocols and potentially uncovering insights that people might overlook – but there’s no real reason for that fear.”
Rao urged the industry to be more transparent: “We need to make this kind of data available. Patients in a trial want to fully understand what they’re signing up for. Imagine a patient uploads a protocol and asks, ‘What will I go through in this study?’ AI could then analyse related data and provide a clear summary, helping them make better decisions.”
Right tool, right use case
Cole Eshbach, Senior Clinical Trial Manager at Endo cautioned that while AI is powerful, it’s not always the right tool for every trial situation. “There’s a popular saying right now – AI can be like a nail looking for a hammer,” said Eshbach.
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By GlobalData“Just because AI is available doesn’t mean it’s the best solution for your needs. If you don’t have a large trial database or the necessary infrastructure, it might not be the most cost-effective option. Sometimes, a simpler tool you already have can do the job just as well.”
Bryan Clayton, founder and CEO of BC Consulting Group, encouraged attendees to experiment with AI tools through everyday conversation. “My advice to people is simple: talk to ChatGPT, or whatever AI tool you’re using like you would talk to a person. First, treat it like a conversation. Second, ask it what you should be asking. It might sound odd, but say, “Hey ChatGPT, what should I ask you about this protocol or topic?” It’ll guide you. If you keep the dialogue going, you’ll start to see its potential – and realise, “Wow, I can actually use this to do something valuable.”
Agentic AI: the next frontier
Looking ahead, Rao pointed to agentic AI – AI systems that can autonomously plan and execute complex tasks – as a major advancement poised to transform clinical trials.
“I built an agent to help with a specific task – checking if anyone else was running a similar Phase III trial. It gave me answers in seconds,” shared Rao. “That’s the power of this technology. It’s the same kind of deep research AI others use, but you can build your own with open-source tools, which is more cost-effective.”
He added that Saama is actively deploying such agents across its platform. “It’s still early, but in the next year or two, we’ll see major time and cost savings. Tasks like data gathering that used to take a lot of manual effort can now be automated. That frees up knowledge workers to focus on more important work.”
Cole Eshbach closed the discussion with a long-term perspective. “We’re not where we need to be yet, but five years from now, the impact of AI could be enormous. Every industry shift now includes AI. It’s going to transform our field, and the sooner we adapt, the more we’ll benefit – saving money, speeding up timelines, and improving things for sites and participants.”
