Clinical Trials Day and the Changing Equation of R&D Success

Clinical Trials Day, May 20, comes at a moment of realignment between scientific ambition and execution reality. This annual observance reminds us that behind every development milestone are patients waiting for answers, and investigators, site teams, and sponsors working across the R&D ecosystem to deliver them. It is also a moment to recognize those contributions and consider how the practice of clinical research continues to change. In 2026, that reflection feels especially timely.

Across recent C-suite discussions with large pharmaceutical companies, a consistent message is emerging: clinical research productivity has improved, but those gains are not yet structurally durable. While progress is being made in key areas of development, the broader system continues to face mounting pressure.

Pricing constraints, intensifying global competition, rising trial duration, and increasing cost per asset continue to challenge traditional research and development models. This is while sponsors are being asked to deliver more amid heightened scrutiny of return on investment. These forces are reshaping not only what research is pursued but how it must be delivered.

Yet this moment also represents a meaningful opportunity. Today’s productivity challenges are no longer driven primarily by scientific capability or access to technology, but by how clinical research is executed—through people, operating models, and the ability to orchestrate development programs holistically across the lifecycle. As a result, clinical research execution has emerged as a strategic capability in its own right, underscoring why execution strategy is now as critical as scientific ambition in determining development success.

Productivity gains: signaling a new reality

Insights from the recently published Global R&D Trends 2026 report¹ by the IQVIA Institute show that, overall, clinical development productivity improved in 2025, driven largely by stronger late-stage performance.

This marks a meaningful shift from the pandemic-era erosion of productivity, when disruption and operational strain weighed heavily on development outcomes.

However, the report also makes clear that these gains are not yet structural. End-to-end clinical development timelines have lengthened again. After improving in 2023 (9.7 years) and 2024 (8.9 years), total end-to-end clinical development duration rose to 10 years in 2025, which matches the 2022 peak. This reflects persistent program-level complexity and friction across development programs.

Taken together, these findings point to a fundamental shift in where productivity is won or lost. Success is no longer determined solely within individual studies, but by how effectively sponsors manage transitions between trials, across regions, and among internal teams and external partners. Increasingly, clinical development performance hinges on program-level coordination and orchestration.

Going from trial execution to program orchestration

Report findings suggest that some of the most significant remaining opportunities to improve R&D productivity lie beyond individual trial execution. Despite improvements in trial-level productivity, development programs continue to experience significant delays outside individual studies.

These challenges are most evident at transition points where decisions, resources and readiness must align as assets move from one phase to the next. Even well-executed trials can be offset by slower handoffs, extended decision-making, or misalignment across teams and partners.

Taken together, the data point to a shift in how productivity must be addressed. Increasingly, success depends not only on executing individual studies well but also on managing clinical development as a continuous, coordinated system and elevating program-level orchestration as a defining capability for R&D leaders.

Productivity versus overcomplexity: A delicate balance

As execution improves at the study level, a new challenge is coming into focus: managing growing complexity without eroding hard-won productivity gains. In turn, sponsors are navigating a delicate balance between scientific ambition and operational feasibility.

Rising protocol complexity, expanding data requirements, and longer development timelines are placing added pressure on sites and internal teams even as execution within individual trials improves. At the same time, evolving portfolios and global development strategies are challenging traditional operating models and resourcing.

The challenge sponsors face today is less about innovation and more about ensuring complexity is intentional and tied to meaningful outcomes.

Productivity gains earned in recent years risk being undermined if organizations rely on rigid structures and reactive ways of working. Increasingly, sponsors are reassessing how development work is structured, sourced, and coordinated to ensure operating models can adapt as portfolios evolve. This includes reevaluating insourcing versus outsourcing strategies, embracing more modular delivery models and ensuring that operational design aligns with portfolio volatility. Clinical development success increasingly depends on how well organizations adapt their operating models to changing pipeline realities.

The human side of execution

As clinical development grows more complex, site relationships and workforce sustainability are emerging as critical determinants of success. While productivity has improved in key areas, the 2026 report cites persistent pressure across development programs, which increasingly manifests at the site and study-team level. This is occurring alongside regulatory expectations that increasingly support more real-time, adaptive clinical trial models, placing greater emphasis on timely data, proactive oversight, and consistent execution at the site level.

That pressure is most visible in patient enrollment, which the report calls the single most important opportunity to accelerate clinical trials. Enrollment timelines increased between 2024 and 2025 (14.9 to 16.3 months), underscoring that program-level progress remains highly dependent on site capacity and engagement. Increasingly, sponsors are seeing stronger enrollment outcomes when site engagement begins earlier—during feasibility and study start-up—rather than when recruitment pressure emerges during active delivery.

To address persistent enrollment and engagement gaps, sponsors are increasingly adopting site enablement models, including embedded support personnel like clinical trial educators. Working alongside site teams, CTEs assist with patient identification, reinforce protocol understanding, and help sustain engagement across critical study phases. Enrollment, more than any other phase, reflects the strength of these human and operational relationships.

Investigators and coordinators are navigating rising protocol complexity, expanding global footprints, and growing administrative burden, often without corresponding increases in capacity or continuity. These dynamics introduce execution risk that cannot be solved through technology or process optimization alone. Without additional, practical support, such as patient-focused education or targeted site enablement during critical study phases, this imbalance can erode site confidence and willingness to prioritize enrollment, particularly in competitive or high-burden trials. Even well-designed trials can falter when site workloads become unrealistic, communication breaks down, or engagement is treated as transactional rather than strategic.

Operational excellence will always begin with human connection. Clear communication, realistic expectations, and sustained partnerships are essential to maintaining enrollment momentum, data quality, and trial predictability. This is especially important in global and hybrid studies where variability in infrastructure and staffing can amplify risk.

Sponsors that treat site engagement as a strategic lever, rather than a downstream operational task, are better positioned to protect timelines and outcomes. Strong, consistent site relationships support faster startup, more reliable enrollment, fewer protocol deviations, and higher‑quality data.

In today’s environment, execution risk driven by people and capacity is as consequential as scientific risk and must be managed with the same level of intent.

AI’s real impact emerges: Orchestration

Early conversations around artificial intelligence in clinical research have focused largely on automation and analytics. As adoption accelerates, however, a more transformative role is coming into focus. Artificial intelligence’s (AI) greatest value may lie not in optimizing individual tasks, but in its ability to orchestrate clinical development, aligning decisions, execution, and readiness across the lifecycle.

AI‑enabled solutions are increasingly being applied to key clinical development activities, including study startup, patient identification and enrollment, and data handling. Increasingly, they are also being explored as a way to address one of the largest remaining sources of inefficiency in clinical development: intra-trial intervals, or the “white space” between trials. By supporting more informed decision-making, smoother protocol transitions, and earlier regulatory and operational readiness, AI has the potential to help sponsors maintain momentum as programs move between phases. This shift toward more real-time adaptive trial execution is also moving AI from proof-of-concept toward transparent, audit-ready, and inspection-ready use in live delivery environments.

But technology delivers value when it creates space for people to make better decisions instead of just adding another layer of abstraction.

Intra-trial intervals remain a significant contributor to development timelines. Even well-run studies can be offset by delays caused by late portfolio decisions, misaligned resources or readiness gaps. Used thoughtfully with human oversight and guidance, AI can help organizations navigate complexity with greater intent. Through these solutions, sponsors can shift from reactive to more proactive operating models, identify bottlenecks earlier, align teams and resources sooner, and reduce idle time between studies.

Why this moment matters

Clinical research has always been complex. What has changed is where success is determined.

Today’s competitive advantage is shaped by disciplined yet flexible execution and by genuine commitment to the people—investigators, site teams and patients—who make clinical trials possible.

Fine-tuning this balance requires aligning innovation with feasibility, ambition with sustainability, and speed with uncompromised quality. Deeper alignment across sponsors, partners, and sites to treat each other as integral parts of a connected clinical research ecosystem is also essential.

The gains in R&D productivity we are seeing are real but sustaining them will require meaningful change. Durability will depend on whether stakeholders are willing to evolve how clinical research is executed, not solely what is being studied.

This is why clinical research matters more than ever. It is not only as a pathway to scientific innovation but also a measure of our industry’s collective responsibility and ability to adapt, collaborate, and deliver meaningful outcomes for patients worldwide.

About the author

Brian O’Dwyer is president, global clinical development, at IQVIA, where he leads global clinical operations across full-service and functional delivery models as well as patient and site-centric solutions and clinical trial supplies.

With more than 27 years of experience spanning clinical research and laboratory services, including serving as chief executive officer of IQVIA Laboratories, he is a recognized industry leader focused on advancing R&D productivity, executional excellence, resilient modern clinical operating models and stronger sponsor-site partnerships.

Reference

1. IQVIA Institute for Human Data Science. Global R&D Trends 2026: Advancing Innovation in a Changing Landscape. March 2026. Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-r-and-d-trends-2026