Though we’re reluctant to admit it, the phrase “If you build it, they will come” aptly describes how clinical research professionals approach adopting a transformative innovation. Popularized by the 1989 movie Field of Dreams in which an Iowa farmer—played by Kevin Costner—builds a baseball field after a mysterious voice tells him to do so, the phrase expresses the belief that the mere decision to invest and begin adopting an innovation will automatically attract broad support and usage.

But as many senior R&D executives have explained to me, the opposite outcome appears to be the norm: If you build it, they will not come.

R&D executives argue that pharmaceutical and biotechnology companies decentralize adoption, leaving individual functions with the challenge of having to fight for and persuade the use of a transformative innovation. As a result, full adoption takes too long, and internal resistance, risk aversion, and misaligned incentives ultimately result in minimal impact. Some executives have suggested that maintaining a centralized approach, with sufficient investment and senior executive support, would have accelerated adoption.

A 2023 study conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) among 255 pharmaceutical and biotechnology companies affirms these arguments to a point. Our study found that recent innovations supporting clinical operations—such as CTMS, risk-based monitoring, and patient-centric practices—take each company an average of six to seven years to fully implement. Nearly all companies (90%) reported relying on a decentralized approach to promote adoption. And nearly eight out of 10 companies (78%) felt that the process took much longer than expected.

But our research also suggests that the value of decentralizing the adoption process is more nuanced. Given the complexity and collaborative fragmentation of clinical research operating activity, decentralization appears essential. The underlying causes of a protracted adoption process and limited utilization may be most associated with change management ineffectiveness.

Seeds of future failure

Following a “trigger” or motivation to consider an innovation, the adoption process typically unfolds with a period of initial exuberance. Gartner’s Hype Cycle model of adoption, introduced in the mid-1990s, calls this the “Peak of Inflated Expectations.” Senior leadership, often reacting to external pressure from competitors, policymakers, regulators, investors, or the public, identifies a core problem such as rising costs, prolonged timelines, high levels of inefficiency, poor patient enrollment, or declining productivity. An innovative solution catches senior management’s attention and is framed as transformative, offering dramatic change rather than incremental improvement.

During this initial phase, investment is committed and flows relatively freely. Dedicated budgets are established, senior-level endorsement is visible, and centralized teams are created to design and deploy the transformative innovation. Governance is simplified, at least temporarily, to accelerate decision-making. The organization signals its commitment by engaging external vendors, consultants, and technology partners, often at significant cost. Early pilots are selected carefully to maximize the probability of success. The innovation is treated as an enterprise asset rather than an operational tool, with ownership sitting at the corporate or global function level.

This centralized, well-funded approach creates early momentum, but it also plants the seeds of future failure. The innovation is typically designed and promoted by a small group removed from day-to-day clinical trial execution. This centralized team may possess strategic vision and technical expertise, but it often lacks deep understanding of how functions operate separately and interdependently, of therapeutic area nuances and vendor dependencies. As a result, deployments of the innovation reflect an idealized version of how clinical operations should work, not how it actually works.

In time, friction between the centralized mechanism and day-to-day operating activity within functions increases. Deployments receive inconsistent levels of support. The promised benefits of the transformative innovation are delayed or only partially achieved, at the same time that the burden and disruptive nature of accommodating that innovation are felt acutely. The value proposition of the innovation remains abstract. Clinical teams respond rationally and accordingly by minimizing use and reverting to familiar legacy practices, tools, and processes. This is the period that Gartner calls the “Trough of Disillusionment.”

Reversing a downward spiral

At this point, the initial strength of centralization becomes a liability. When adoption threatens short-term performance—and incentive structures—teams quietly deprioritize the new solution. Utilization becomes less consistent, and the original value proposition becomes even more elusive. Sponsor companies next enter a phase of retrenchment. Senior leaders, observing limited uptake and ambiguous impact, lose their patience and begin to question their original motivation and investment thesis. Funding is reduced or reallocated. Headcount in the centralized group is frozen or downsized. Governance becomes more cautious and restrictive. What was once positioned as inevitable becomes optional. Early champions leave or rotate into other roles, taking institutional knowledge with them. Pilot deployments are relegated to lower priority projects.

Decentralization reallocates ownership of the innovation to those who bear the executional risk. So begins the period that Gartner calls the “Slope of Enlightenment’.” Over time an innovation shifts from being promoted as a stand-alone panacea—and an imposition for clinical teams—to becoming one of many tools that can be deployed as needed based on real experience. Decentralization permits adoption decisions to be customized and integrated into project-level operating activity.

Decentralized approaches eventually lead to incentive alignment. Clinical teams and individual functions are more likely to invest in adoption when they can capture and monitor visible benefits (e.g., faster cycle times, improved efficiency, and cost advantages) within their span of control. This creates function-level demand and support for the innovation, replacing mandate-driven compliance with grassroots usage. Over time, metrics and benchmarking help facilitate usage and continuous improvement.

Optimizing decentralization

For most, the adoption of transformative innovations supporting clinical research operations is painfully slow and highly inefficient. Initial exuberance marked by centralized mechanisms creates early visibility and momentum but fails to engage organizations at the executional level, resulting in retrenchment and decentralization. The innovation remains built and ready to be leveraged, but users are not prepared to do so until they have direct experience. As a result, this shift from centralized to decentralized adoption is essential.

But for most companies, this shift it is not intentional. Adoption of a transformative innovation is protracted and inefficient in part because organizational change is not well planned and managed effectively. When is the right time to make the shift? What organizational levers (e.g., training, incentives, operating practices, metrics, communications) can be better managed and modified to facilitate this shift and optimize the effects of decentralization? What best practices inform how to address between-function friction and varying and inconsistent levels of adoption support?

These questions and many others are at the heart of a new working group study that Tufts CSDD has launched to understand and benchmark change management experiences and identify best practices. To our knowledge, this is a first-of-its-kind study and we encourage sponsor companies to join us.

Change management in clinical research operating functions is difficult because it must accommodate a very complex operating environment, highly risk-averse cultures, highly regulated and deeply embedded legacy operating practices, and well-established economic incentives and governance models. Overcoming these barriers requires leadership discipline, careful planning, focused investment, and a reframing of change not as a disruptive cure-all, but rather as an enabler of multifunctional performance, efficiency, and quality improvement.

Enterprise-wide adoption of a transformative innovation supporting clinical research operations requires decentralization because the value proposition must be realized at the functional level, risk must be managed locally, and behavior change must also occur at the local, functional level.

Decentralization should not be seen as affirming the phrase “If you build it, they will not come,” but rather as a necessary stage of innovation deployment that is ripe for optimization.

Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine