#2 – AI won’t replace you, but a person using AI will

In the hallowed halls of clinical research, where trial protocols are meticulously followed and every CRF query is treated like a mini work of art, one question looms larger with the rise of AI: will artificial intelligence take over? I have written about this in my previous post “The Secret AI Society: Are You In?” which you definitely should check, but the short answer is no, not yet. AI will not march into your office, sit in your chair, and start dictating monitoring reports. However, your colleague—the one embracing AI tools—might end up taking the lead, snatching the long-desired promotion you have been both competing for. You have had a good run, head-to-head, but at some point, your adversary changed overnight. They started sending perfectly structured and comprehensive email responses in half the time. And no, they didn’t just “work harder.” The secret is, they started incorporating AI in their daily work. Are you familiar with the old English proverb “two heads are better than one“, which used to say that it is easier for two people who help each other to solve a problem than it is for one person to solve a problem alone. Well with the rise of AI, and it’s constant evolution, you now come very close to have basically a free second head at your disposal — a virtual assistant ready to help.

For clinical research professionals, this prospect feels both exciting and unnerving. You’ve spent years becoming an expert in managing timelines, liaising with sponsors, and decoding that delightful chaos that is site monitoring visits. How could a machine possibly replicate that? Well, it can’t. But it can assist someone who’s willing to let it. Making this person far more productive.

AI is already making waves in clinical research—and I strongly advise you to learn to surf.

The Myth of AI “Replacement”

Let’s debunk this whole “AI is coming for your job” myth. Sure, AI can analyze massive data sets faster than we can watch a Netflix movie, but it doesn’t have the human touch. It can’t empathize with a site coordinator whose first thought upon hearing “database lock” is of panic, not pride and convince the SC to answer the new queries. It won’t comfort a monitor who realizes they’ve just sent their 47th follow-up email this week. And it definitely won’t crack a joke at the IM about the absurdity of the study timelines and the planned initial submission in 2 weeks, which in the end never works out on time. But yeah – best not to joke too loudly about that anyway if you like keeping your job!

AI is a tool, not a takeover plan. It’s the Swiss Army knife of the future—versatile, useful, but it won’t wield itself.

Clinical Research: Perfectly Safe… for Now

In the world of clinical research, AI has potential, but it’s not magic. It helps getting answers faster than using google, automate repetitive tasks, rephrase your e-mails. As a clinical trial manager or clinical research associate, you already juggle a thousand responsibilities, from site monitoring to sponsor communications. AI isn’t taking over those responsibilities—it’s just making them more manageable for someone willing to adopt it.

But here’s the twist. AI won’t replace you, but the guy or gal next door who’s embracing AI tools might just edge you out. The key difference? They’re not working harder; they’re working smarter. And that’s where the future of clinical research is headed.

Your Friendly Neighborhood AI Assistants

AI can be your secret weapon, and it comes in many forms. The industry has already started weaving AI into various aspects of clinical trials, from planning to execution. And if you do the math, it’s clear that this trend will only keep growing and evolving year after year. Here are a few examples.

1. Protocol Assistants: AI is already capable of assisting with protocol design. Tools like IBM Watson Health can analyze previous trials, suggest optimal endpoints, and even predict the success of a study based on historical data. So while you’re racking your brain over how to word that pesky secondary endpoint, someone else is letting AI do the heavy lifting.
2. Trial Recruitment: One of the biggest bottlenecks in clinical research is patient recruitment. AI-driven recruitment platforms such as Antidote and Deep 6 AI using natural language processing and machine learning, can sift through medical records faster than a human screening the data base on the Monday morning. These systems match eligible patients to trials, saving weeks or even months of screening time.
3. Data Cleaning & Analysis: Remember those data cleaning marathons that made you question your life choices? AI-powered analytics tools can identify anomalies, outliers. While you might still manually be checking each page of the CRF at your company, there are already some that started incorporating AI into the EDC systems, automating these processes. 
4. Risk-Based Monitoring: RBM, Central Monitoring, Patient-Centric-Monitoring or whatever the CRO prefers to call it, is already a big thing, and AI makes it smarter. Machine learning algorithms can analyze data from multiple sources, predict risk at different sites, and help allocate resources more effectively. Instead of relying on traditional, often reactive approaches, AI enables a proactive stance.

Now, those examples might seem a little distant from your day-to-day tasks, but the point is to show how AI is creeping further into the industry. It’s now your turn to get creative and figure out how you can use AI to speed up your work and boost your efficiency. And here’s a little teaser—keep an eye on my blog. I’ll be sharing some wild life hacks soon on how people are outsourcing parts of their CRA, CTM and PM roles to AI, and you can do it too.

The Human Touch That AI Can’t Replace

So, where does this leave you? After all, you’re more than your data-cleaning prowess or your ability to screen subjects. Your strengths lie in the human aspects of clinical research—the nuances that AI can’t replicate.

• Communication & Negotiation: AI can’t soothe a frustrated site that’s behind on data entry or explain complex protocol amendments to an overworked PI that shows up only for 5 minutes at your monitoring visit. Human interaction (if done correctly) is still the key to smooth trial operations.

• Problem-Solving & Crisis Management: Let’s face it: clinical trials rarely go off without a hitch. There will always be an unexpected event—an investigational product that’s delayed, a site that didn’t follow the protocol, or a data entry error that throws off timelines. AI can help identify these issues, but only a human can resolve them with finesse.

• Relationship Building: whether your CRO wins the next bid-defense is often built on relationships—with sponsors, sites and even within your team. AI won’t win anyone over without a well-timed joke or understanding of the shared frustration of a last-minute deadline. You, on the other hand, can.

• Decision-Making in Gray Areas: Clinical research is rarely black and white. Deciding when to escalate an issue, how to handle a protocol deviation, or when to over-communicate with a sponsor requires a judgment call that AI simply can’t make—at least, not yet.

How AI Could Change Your Day-to-Day Life

Now that we’ve established you’re not about to be replaced by a soulless robot, let’s get real: AI is about to make your work life a whole lot better. Imagine a world where you no longer spend hours cleaning up data or wading through spreadsheets. Instead, you could focus on high-level strategy, team management, and even a little more work-life balance. Yes, that mythical work-life balance…

In future the clinical research could be shaped with the help AI tools, and while yet hypothetical your day could look like this:

•  Morning: Check in on AI-driven trial recruitment software to see how patient screening is progressing. No more tedious phone calls with sites to track recruitment status.

• Mid-Morning: Review an AI-generated summary of site monitoring reports that highlights discrepancies, reducing the time you spend manually reviewing each report.

• Lunch: Grab lunch with a colleague while AI-based software flags any data discrepancies that need your attention.

• Afternoon: Use AI-driven risk-based monitoring insights to prioritize which sites need immediate attention. No more wasting time on low-risk sites when high-risk sites are calling for your expertise.

• Late Afternoon: Relax, knowing that your AI assistant has drafted the agenda for your next sponsor meeting. All you need to do is review and personalize it.

And voila! More time for the work that matters.

Don’t Fear the Bot—Embrace It!

AI isn’t here to steal your job. But your colleagues who are looking ahead, might have already grasped the power of AI. They might just outshine you. The key is to get ahead by embracing the technology and using it to your advantage. In clinical research, the world is already fast-paced and unpredictable. With AI, you can reduce the mundane tasks that bog down your day and spend more time focusing on what you do best: solving complex problems, communicating with your team, and making trials run smoother.

Don’t allow someone become a head of you using AI, you don’t want to be the one left behind when your colleague is automating their tasks and breezing through their workload. You’ve worked too hard to let that happen.

As we look to the future, the moral of the story is simple: don’t fear the bot. Learn to work with it, and you’ll be unstoppable in clinical research. After all, AI can’t replace your human touch—but the smart use of AI can make you an even more valuable asset to your team and your sponsors.

Plus, you’ll still get to make all the protocol deviation jokes at the next investigator meeting.

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