2026 Forecasts From People Smarter Than Me – Part 1

By Dan Schell, Chief Editor, Clinical Leader

After a year spent digging into everything from AI oversight and site sustainability to the FSO-versus-FSP debate and the slow-motion rollout of new FDA guidances, I figured it was time to flip the script. Instead of me calling the shots, I asked some of the smartest people in my clinical-trials orbit to look ahead to 2026. What follows is part 1 of their take on the trends, pressure points, and surprises that may shape the next year of clinical operations.

• 2026 will be defined by uncertainty — geopolitical instability, volatile global markets, and shifting health policies will influence every choice pharma companies make. From clinical trial planning to pipeline priorities, leaders will increasingly weigh innovation against risk, trying to preserve momentum while navigating an unpredictable global landscape.
• Regulatory uncertainty also will intensify in 2026, and it will manifest differently by region. In the U.S., FDA leadership churn and talent flight could slow approvals and guidance. In Europe, ongoing trial outmigration and delays around reforms like the Biotech Act threaten long-term innovations. Companies will need to navigate these dynamics carefully while keeping their focus on delivering therapies to patients.”
• Shrinking health budgets — from defense spending in Europe to Medicaid and NIH cuts in the U.S. — will force companies to prioritize ruthlessly. Cost vigilance and operational efficiency will be paramount as sponsors manage R&D pipelines in a tighter financial environment.
• Developing a robust pipeline will demand ingenuity. Partnerships, acquisitions, and AI-driven innovation will be key levers, allowing companies to advance promising programs while managing ongoing costs and risk. In a tight financial climate, pipeline strength becomes the measure of long-term viability — making strategic ingenuity non-negotiable.
• AI has the potential to accelerate R&D, reduce costs, and modernize trials, but adoption remains the question. Will pharma embrace this technology to transform drug development, or will uncertainty and ingrained conservatism lead to a retreat to familiar methods? 2026 will test whether uncertainty becomes a catalyst for transformation or a reason to hold back.

Bring Your Own Technology (BYOT) is on the rise!  2026 holds promise for sponsors investing even more in understanding site needs and leveraging existing site technologies.   While AI dominates much of the discussion these days, and while “being the sponsor of choice” has been an undercurrent for years, we are starting to see substantive action by sponsors to address the technology burden sites face.  Various industry initiatives and publications suggest that sponsors finally recognize the investments sites have made in operational and clinical technologies (including digital health technologies or DHTs).  I’m hopeful that integration with site tech stacks will continue so we can finally realize the true potential of all that these technologies have to offer.

Globally in 2026, the primary strategic imperative is the mandatory institutionalization of ICH E6(R3) Good Clinical Practice, compelling all sponsors to integrate Risk-Based Quality Management (RBQM) into auditable, production-ready enterprise systems . This modernized framework supports the essential scaling of technologies like AI for automated protocol optimization and DCTs to achieve faster, more resilient global trial execution. Loco-regionally, US operations face the urgent, non-negotiable January 1, 2026 deadline for the FDA’s Diversity Action Plan (DAP), which demands immediate utilization of RWE analytics to set and justify diverse patient enrollment goals. Operational success hinges on strengthening the sponsor-CRO-solution provider-NGO-site relationship by proactively reducing site administrative and technological burden to maintain capacity and accelerate critical study start-up timelines, whilst leaning into the deeper partnership integration momentum we are seeing with protocol development enhancements and more meaningful, productive and actionable interactions across our global clinical trial and drug development ecosystems.

The stage is set for a strong rebound in CRO financial performance in 2026. Biotech funding is trending back up, biotech equities as a group are very strong, and pharma spend that was held back in recent years appears to be getting unlocked. CRO performance is already evidencing the rebound of the past couple quarters, and CRO executives are talking much more optimistically about the next 12 months than they were the past 12 months. The key thing I'll be looking for is whether the rebound includes genuine growth in organic service fees, or instead, a continued boost from artificial items like pass-through costs and exchange rates.

Clinical research in 2026 is shaping up to be a year of brutal efficiency and massive reinvention. AI stops being a shiny add-on and becomes the backbone of trial design, patient matching, and real-time decision making. Sponsors push hard into hybrid and decentralized models to fix enrollment bottlenecks and widen access, while global site networks in Asia and LATAM expand because U.S. timelines and budgets aren’t getting any easier. At the same time, the industry faces tight capital, higher regulatory scrutiny, staffing shortages, and intensifying pressure to deliver ROI on every protocol decision. Cell and gene therapy trials surge, diversity becomes non-negotiable, CRO consolidation accelerates, and underpowered or slow-moving studies simply won’t survive the year. In short, 2026 rewards the sponsors and sites that run clinical research like a high-performance business and punishes anyone still operating like it’s 2012.