More 2026 Clinical Predictions
By Dan Schell, Chief Editor, Clinical Leader
This is part 2 of my article about predictions for the clinical trials industry in 2026. From my reporting on AI growing pains, site-network shakeups, and the never-ending sponsor–site tension over feasibility and budgets, it’s clear the industry is carrying plenty of unresolved business into the new year. Luckily for me, the folks I asked to weigh in on what’s next in this industry really came through. So, enjoy (if you can) these perspectives on everything from the risks, to the opportunities, to the headaches we’ll all be talking about by spring.
In 2026, the importance of strong partnerships between sponsors and clinical research sites will only grow. Sponsors truly need to collaborate with our clinical sites to be efficient and successful. Our clinical research sites are facing persistent challenges: increasing protocol complexity, staff turnover, patient retention, the list goes on and on. Clinical trial sites face many challenges around the successful execution of study startup. These included:
- participants walking out from visit due to delays and system failures
- inadequate planning and site readiness assessments
- study coordinators juggling multiple protocols and sponsors, each with unique systems and requirements.
- staff burnout creating high turnover
- negative online perceptions eroding trust in clinical trials
- inefficient data management due to poor system integration and siloed teams.
Thus, sponsors must be open-minded and work to make changes that make life easier for our sites. We must remember that all sites are different and work to customize our approach to help our sites. Personally, I find that simple, easy solutions are what we need at times, nothing fancy/nothing expensive. We need good, open communication and clear expectations to our sites. There are many small things sponsors can change that can make a huge difference for our sites. Step 1: simply pay on time! I hope that sites remain a pivotal focus as truly key for our success!
Clinical research enters 2026 as stable but stuck. Hiring won’t bounce back until regulation, reimbursement, and AI uncertainty clear. Global trial expansion will stay conflicted as the lack of support for US research centers drives sponsors abroad while political pressure for domestic investment pulls them home. Digital innovation (digital endpoints, decentralization) grows only with companies making meaningful commitments; the rest will simply experiment with AI. And the industry can’t be both site- and patient-centric forever—sites are demanding for attention with more volume, which may leave attention on the needs of the study participant lacking.
With a more favorable investment climate, expect continued consolidation on both the technology and site network sides. Site networks will become increasingly central to sponsors, who will rely on them for a broader range of studies and therapeutic areas, particularly those who are predictable, high-quality, and efficient (i.e., tech-enabled) at scale. At the same time, I expect AMCs to find ways to innovate to stay top of mind for industry studies (e.g. faster study start-up and data collection) now that government funded studies are more limited.
Sponsors are becoming more aware of the tech burden they’ve historically placed on sites, prompting a shift toward site-centricity. This will bring genuinely helpful solutions but also more noise, making interoperability, thoughtful integration, and pragmatic site-friendly solutions essential rather than optional.
DEI investment will see a healthy resurgence, this time grounded in scientific rigor and post-market necessity rather than regulatory requirement.
Sponsors will keep experimenting with building AI capabilities internally, particularly where they have unique data sets or workflow needs but will increasingly rely on established external partners/solution providers for areas requiring deep expertise or (more) rapid execution. Anywhere AI can replace high-cost resources that cause delays will be seriously considered and used — where risk can be mitigated appropriately of course.
Digital twins and synthetic data with promise of reducing enrollment numbers required will get more press; this will likely make progress but remain in early innings so expect pilots and press releases but not yet use at scale.
And the regulatory landscape will continue to keep everyone on their toes, so expect plenty of pivots we can’t yet predict.
For years, our industry has fallen into a familiar trap—chasing the latest “shiny new toy.” Too often, that toy has been technology. We’ve embraced a “there’s an app for that” mentality, believing that if we throw a challenge into a tech solution, the problem will magically disappear. But experience has taught us otherwise: Technology is a powerful tool—but it’s not a cure-all.
The recent explosion of AI has only intensified this cycle. Yes, it’s powerful. Yes, it’s transformative. But it also raises profound questions about authenticity, trust, and what’s real. That constant uncertainty has amplified skepticism and fatigue across the industry —and it reminds us of something essential: progress isn’t just about algorithms. It’s about people.
That’s why my prediction for 2026 is simple yet radical: Human connection will become the ultimate innovation. Face-to-face collaboration — the kind where ideas spark across a table, where trust is built in real time — will be the new “shiny object.” And it won’t just feel good; it will drive results.
We’re already seeing the signs: Conferences are booming, attendance is climbing, and the hunger for genuine interaction is undeniable. Why? Because these gatherings deliver what technology cannot — speed, trust, and shared purpose.
At Takeda, we’ve never lost sight of this truth. Our Study Site Engagement team is committed to fostering personal connections, because we know that the future of clinical trials isn’t just digital; it’s deeply human. In a world obsessed with virtual, the real competitive advantage will be real conversations.
2026 won’t belong to the next app or algorithm. It will belong to those who invest in relationships. And that, in my view, is the ultimate essential innovation — and the ultimate opportunity.
- In 2026, RWD won’t just inform regulatory decisions, it will shape the future of clinical care. As regulators and pharma companies alike embrace these insights, investment in technologies that tackle interoperability while protecting privacy will surge. The global regulatory landscape is evolving fast, and companies that harness data intelligently will stay ahead of both compliance and patient needs.
- AI’s role in clinical development is expanding beyond automating routine tasks and generating documents. In the near term, it’s about faster timelines and higher-quality outputs. But the real opportunity lies ahead: virtual controls, digital twins, model-informed study design, and fully modernized, end-to-end clinical trials. By 2026, AI will be central to how trials are planned, executed, and analyzed.
- The adoption of ICH-E6(R3) and E19 guidelines will make 2026 the year patients truly shape clinical research. Trials will be designed with real patient input, streamlining procedures, expanding access, and maximizing the value of collected data. Decentralized and pragmatic trial elements will scale, enabling patient-focused studies that are faster, more inclusive, and ultimately more impactful.