Clinical Trials in 2026: Predictions from the PBC Group Advisory Board

As we enter 2026 the clinical trials industry stands at a pivotal juncture. The challenges and innovations of 2025 have set the stage for what promises to be a transformative year ahead.

We gathered insights from four PBC Group advisory board members; Helen Blanco, Andy Thurstan, Sverre Bengtsson, and Joan Chambers, to understand what lies ahead for sponsors, CROs, and the broader research ecosystem.

The Funding Crisis: 2025's Defining Challenge

Perhaps the most striking consensus amongst our advisory board is the identification of funding as 2025's most significant operational challenge. This wasn't merely a financial constraint, but a catalyst that forced the industry to fundamentally reassess its approach to clinical development.

Helen Blanco characterises the situation plainly: "The biggest operational challenge of 2025 has been adequate funding for clinical development." She emphasised that the lessons moving forward must include "adequate risk assessment related to strategy, choice of therapeutic areas and assessment of the competitive market."

Andy Thurstan places this challenge within a broader political and economic context, noting that "with purse strings already pulled tight, the US presidential election result and subsequent 'reshuffling' of FDA priorities, shall we say, as well as ongoing jitters all seem to have stymied growth in our industry." Yet he strikes an optimistic note, reminding us that "if you look at what progress has been made since 2008, despite everything there is still a lot of opportunity and hope."

Beyond Funding: The Evolution of Operational Complexity

Whilst funding dominated the headlines, other operational challenges also evolved. Joan Chambers offers a nuanced perspective on trial complexity itself, highlighting "how we tackle clinical trial complexity and its ripple effects across site execution and overall clinical operations." She noted that "modern study designs, with multiple endpoints, adaptive protocols, protocol amendments, and integrated digital tools, have increasingly stretched research sites' capacity, extended timelines, and driven up costs."

The emergence of different site execution models - traditional on-site, hybrid, and fully decentralised - has fundamentally reshaped clinical operations. Joan commented that "hybrid and decentralised trials bring tremendous opportunities for patient inclusion, flexibility, and convenience, but they also introduce new operational demands on research sites."

Sverre Bengtsson identified a critical shift in focus: "In 2025, the biggest operational evolution was the mainstream adoption of decentralised and AI-enabled clinical trials, backed by more clear regulatory guidance and real-world validation." He noted that the question has evolved from "if and what we could do" to "if we can trust and govern the data." This pivot towards data credibility, interoperability, and patient-centricity represents a maturation of the industry's digital transformation.

Artificial Intelligence: The Technology to Watch in 2026

When asked about the emerging technology with the greatest potential impact on trial efficiency in 2026, all four converged on a single answer: artificial intelligence. However, their perspectives reveal different facets of AI's transformative potential.

Helen emphasised AI's comprehensive benefits: "Adequate use of AI can reduce cost, reduce manpower, increase timelines and most of all, provide analyses using a very high amount of data points."

Andy highlighted the practical applications already emerging: "We are finally starting to see what Big Data can do and I believe there is so much more to come from synthetic study arms and real world evidence as 'smart', controlled AI evolves."

Sverre points to a specific application gaining traction: "Through the emergence of the LLM's that are clinical trial centric, authoring tools will have an increasing impact on study design, feasibility, authoring of documents, and the management and oversight of clinical trials." He added that "the oversight is getting really good, no-one or no problem can hide anymore."

Joan provides perhaps the most comprehensive vision, arguing that "the continued use and implementation of generative and predictive AI across the clinical trial ecosystem will have the greatest impact on clinical trial efficiency." She emphasised that AI is moving "beyond task automation into predictive decision support," enabling teams to "anticipate risks - whether it's slow enrolment, data inconsistencies, or unanticipated site burden - and then teams can intervene before those issues become costly delays."

Importantly, Joan reminds us that "AI is not about replacing human experience." Rather, "what is exciting for me is the evolution of AI and how AI amplifies the value of clinical teams by reducing manual burden and enabling professionals to focus on complex problem-solving, collaboration, and patient engagement."

Strategic Imperatives for 2026: Capabilities and Shifts

Looking ahead, the board identified several critical organisational capabilities and strategic shifts necessary for remaining competitive in the evolving landscape.

Digital Transformation and Regulatory Compliance

Helen commented on the impact of updated regulatory guidance: "With the recently updated ICH guideline (E6(R3)), I believe both sponsors and CROs need to develop their digital platforms to ensure efficiency." She also advocates for increased collaboration, noting that "strategic partnerships to allow sharing of knowledge and experience" will be crucial.

Primary Care and Patient Discovery Networks

Andy highlighted an often-overlooked opportunity: "I see the greatest developmental opportunities, certainly in patient identification and recruitment, in primary care." He noted that "there are now patient discovery networks covering more than 10% of the UK population and that model can be extrapolated out into other healthcare systems." His warning is pointed: "CROs need to make sure their traditional recruitment models don't get whipped out from under them and be open to working in more creative ways."

Orchestration and Data-Driven Learning

Sverre introduces the concept of "orchestration" as central to future competitiveness: "We must evolve from operational executors to data-driven learning organisations, blending clinical, digital, and AI expertise under strong data governance." Responding, the need to "orchestrate clinical evidence across multiple designs like RWD/RWE, decentralised models (where applicable), and AI assisted insights." Critically, he notes that "the workforce needs to be upskilled to make full use of all the new processes, designs and tools."

Organisational Agility and Breaking Down Silos

Joan identifies organisational agility as paramount, arguing that "breaking down the silos between clinical operations, data, technology, and patient engagement teams allows decisions to be made faster and closer to the trial." She stressed the importance of "stronger relationships between research sites, biopharma, and CROs," noting that "traditional, site-centric clinical trial models struggle to adapt when protocols evolve, enrolment slows, or supply chain disruptions occur."

Joan also champions a dual focus on both patients and sites: "While patient engagement has become central to designing feasible, participant-friendly protocols, emerging research, which I agree with, emphasises the need and value of incorporating the research site's voice as well." Sites, she argues, are "closest to operational realities, from enrolment barriers to workflow challenges."

Workforce Evolution in the Age of AI

Joan also addressed the human element of technological transformation: "While AI can automate routine processes like eligibility screening or data monitoring, it also shifts the skill sets required for success." ... that "upskilling, clear roles, and strong change management will be essential for enabling employees to collaborate effectively with AI tools whilst maintaining quality, regulatory compliance, and patient focus."

Key Themes Emerging for 2026

Several overarching themes emerge from these expert perspectives:

1. Data Governance as the New Frontier: As Sverre noted, the question is no longer whether we can implement new technologies, but whether we can trust and govern the data they produce. This shift towards credibility and interoperability will define successful organisations in 2026.

2. The Imperative of Simplification: Joan's emphasis on simplifying protocols and workflows echoes throughout the responses. As trials grow more complex, the organisations that can reduce unnecessary burden whilst maintaining scientific rigour will gain competitive advantage.

3. Collaboration Over Competition: Helen's advocacy for strategic partnerships and platform trials reflects a broader industry recognition that shared challenges require collective solutions. The funding constraints of 2025 have accelerated this realisation.

4. Human-Centred Technology: All four experts emphasise that technology, particularly AI, must serve to amplify human expertise rather than replace it. The most successful organisations will be those that successfully integrate AI whilst keeping patients, sites, and clinical teams at the centre of decision-making.

5. Operational Readiness and Agility: As Joan articulated, "industry needs to pair innovation with operational readiness." The ability to adapt quickly, integrate diverse data sources, and pivot when necessary will separate leaders from followers.

2026: A Year of Transformation

As we progress through 2026, the clinical trials industry faces both significant challenges and unprecedented opportunities. The funding pressures of 2025, rather than stifling innovation, have forced a productive reckoning with efficiency, collaboration, and strategic focus.

Andy's optimism seems well-founded: despite the challenges, we simply "need to do what we do, be open to doing things in different ways, and above all sharing our challenges and successes." The convergence of AI capabilities, evolving regulatory frameworks, new execution models, and a workforce increasingly adept at working alongside technology suggests that 2026 could indeed mark a turning point for clinical research.

The organisations that will thrive are those that can balance technological sophistication with operational readiness, data-driven insights with human judgment, and innovation with patient-centricity. As Sverre observes, we are moving "from reacting to be proactive," and this fundamental shift will "change how we work and what we do."

The question is no longer whether change is coming.... it's already here. The question is whether we're ready to embrace it, govern it effectively, and ensure it serves the ultimate goal: bringing safe and effective treatments to patients more efficiently than ever before.

About The PBC Group

Find out more about our COG Series, and Advisory Board below!

https://www.thepbcgroup.com/event-series

https://www.thepbcgroup.com/advisory-board