Were There Any Surprises In Clinical Trials In 2024?

Is it any surprise that when I asked a group of clinical trial industry experts to summarize some of the things that stood out to them in 2024, that AI would be mentioned more than once?  Probably not. Resistance to DCTs, increasing regulatory scrutiny, and a slowdown in CRO M&As also made their lists — but I’m guessing none of that surprises you, either.

Dr. Daniel Fox, Founder & CEO, Clinical Research Payment Network (CRPN)

For me, 2024 was by far the year of AI, healthcare integration, and getting back to normal. I can’t believe how fast and aggressive AI technologies took the world by storm — including research. From investors to flourishing tech, AI was this year’s DCT, and it’s leaving us all concerned about what will happen next.

Then, there’s healthcare integration. With the FDA’s final decentralized method guidance published and a draft guidance to address the relationships between sponsors and healthcare providers directly, we continue to see the future of clinical trials developing in front of our eyes. The sponsor will soon be a direct consumer of healthcare.

Finally, as heartbreaking and unjustified as it is, sponsors continue to insist on pre-COVID budgets with sites. Going as far as to say they are now ignoring all COVID-era budgets as outliers in fair market value and forcing sites into underfunded contracts. As technology continues to evolve, we adjust our methods for patient access to trials, and we as an industry continually work to fight the exponential increases in costs, I’m surprised where the industry is going and concerned, but hopeful, about its direction in 2025.

Beth Harper, President, Clinical Performance Partners

Historically, it takes our industry about 30 years to adopt any innovation (think EDC as a prime example), so it surprises me somewhat that the industry believes AI solutions will suddenly solve age-old challenges when it comes to optimizing clinical trials. Who can blame the enthusiasm, especially when AI is becoming mainstream in our daily lives and has the potential for some important medical advancements?

As a risk-averse industry, however, are we truly prepared to qualify vendors providing AI-related services? Do we have the knowledge and expertise to even know what questions to ask and what to look for?  Where do we feel the adoption will face the least resistance from legal, quality/compliance, and be most embraced by sites and participants? How are we preparing our organizations for this potentially monumental change in the way we are conducting clinical trials?

Mitch Hilbe, CEO/Co-founder, DiversiTrials

One of the most popular trends continues to be the increasing pressure on sponsors and CROs to adapt to remote and DCT models. While DCTs have been in discussion for years, I noticed a surprising amount of resistance from sites for various reasons, such as:

• Sponsors are asking sites to own and manage the tech used for a DCT.  
• Sites are being asked to develop SOPs for the tech used in DCTs.

The tension between innovation and practicality was a recurring theme at conferences and in industry conversations, however, most align with the understanding that these technologies need to exist, we just need to button up “how” they should exist. I foresee the advancement in industry tech solutions, decentralized tools, and risk-based methodologies creating an opportunity for sponsors to pull away from CROs that continue to be of concern and maintain leaner in-house teams to manage studies.

On that note, another topic I have been closely following is how AI is playing a greater role in the industry, such as in trial matching. While I'm skeptical about the ability to truly “close the gap” in diverse patient recruitment, AI clearly has its benefits as a piece of the puzzle. It also seems clear that it needs to be paired with better "unconditional" (i.e., continually being involved, not transactional) community engagement strategies to be effective in achieving diversity goals.

A lot of small to medium-sized sites I’ve worked with have expressed frustration over feasibility processes that seem stacked against them, which speaks to a broader issue of equity within the industry itself.

Looking forward, I think these conversations will be key drivers for significant changes in how we approach trial design and collaboration.

Lindsay Kehoe, Senior Project Manager, Lead, Emerging Programs at Clinical Trials Transformation Initiative (CTTI)

The clinical research community is getting closer to the slope of enlightenment when it comes to digital health trials, but the journey has underscored a key lesson: decentralized approaches and digital tools aren’t one-size-fits-all. The challenge lies in understanding where these tools can add real value — and, where they might fall short. That’s the key to unlocking their full potential.

I’m pleased, but not surprised, to see how regulators have been stepping up to support digital innovation. Whether it’s finalizing guidance on decentralized clinical trials (DCTs) or advancing discussions around model-informed drug development and AI, their efforts are playing a key role in shaping the future of research.

Of course, innovation requires change management, but the pace of progress may dictate that change. In 2025, the rapid acceleration of digital capabilities in drug discovery could lead to a reinvention of clinical trials as we know them — making innovative approaches not just a choice, but a necessity to keep up with demand.

That said, it's important not to conflate innovation with just digital solutions. Sometimes, innovation is about rethinking approaches with greater simplicity and pragmatism — finding ways to do things better, not just faster or more technologically advanced.

Darshan Kulkarni, Regulatory And Compliance Attorney For The Life Sciences, The Kulkarni Law Firm

If 2024 taught us anything, it’s that 2025 is shaping up to be full of surprises. In 2024, compliance and enforcement took center stage. Agencies like the DOJ, HHS, Office of Research Integrity (ORI), the FTC, and the FDA introduced new regulations and updated guidance, making it clear that compliance expectations are no longer just the FDA’s domain. Companies regulated by the FDA now face scrutiny from multiple agencies, each with its own focus:

• DOJ: The DOJ ramped up its interest in clinical research compliance, focusing on fraud and compliance gaps during mergers and acquisitions. With clinical trial sites becoming more critical, their oversight is expanding.
• ORI: The ORI took a more assertive stance, targeting compliance at clinical trial sites, particularly within large academic medical centers.
• FTC: Under Lina Khan’s leadership, the FTC moved aggressively to regulate advertising and mergers, creating a more comprehensive framework for oversight.

Meanwhile, the end of 2024 brought a major shift in leadership. Vivek Ramaswamy, Elon Musk, and Robert F. Kennedy Jr. emerged as vocal opponents of regulation, vowing to cut unnecessary bureaucracies and challenge long-standing practices. Their approach raises questions about the future direction of the U.S. healthcare system: will it steer toward smooth sailing or an iceberg of chaos? One thing is certain — 2025 will demand adaptability and vigilance from everyone in the industry.

Craig Lipset, Advisor & Founder, Clinical innovation Partners

Years ago when I was early in my career at a CRO, the seasoned CEO of the company taught me about “creative destruction.” I experienced this first-hand when I joined a large pharma that soon had a substantial portfolio failure — dismantling many operating models for R&D still created opportunities for agile innovation.

This creative destruction has been happening at scale across pharma in 2024. Headcount reductions, portfolio prioritization, and re-organizations are running in parallel to efforts to better use data and AI. Many are hungry for opportunities to show that AI can sustain a new "leaner" organization going forward.

It may prove challenging, however, for organizations to scale and drive meaningful adoption of new tools without having proper talent in place. The winners will find ways to maintain internal expertise and not swing the pendulum so deep with cuts that they lack the ability to adopt the innovative approaches for their new future.

Joel White, Owner, Marketcap Consulting

I was most surprised by the lack of major M&A by the large CROs, who came into this year trumpeting their large war chests for large deals. Instead, they're now apparently focusing their capital allocation on share buybacks. They've certainly been looking for deals, but not reaching agreement on them, which tells me there is a major disconnect between what potential targets (e.g., sites, tech platforms) expect to get for their businesses, and what big CROs are willing to pay.