The site economy
The diversity behind the siteWhen the industry discusses sites, they often refer to them as a single stakeholder group. In reality, the difference between a major academic medical center and a community-based. . .
The diversity behind the siteWhen the industry discusses sites, they often refer to them as a single stakeholder group. In reality, the difference between a major academic medical center and a community-based clinic can be greater than the difference between two entirely unrelated healthcare systems. Large academic medical centers and dedicated research institutions are supported by extensive infrastructure, specialized research teams and trial coordinators, and have significant experience managing complex global studies. Regional hospitals, community clinics, and physician-led practices permit research activities to exist alongside the demands of patient care. Although these organizations differ in scale, incentives, capabilities, operational maturity, and capacity, the balance between clinical care priorities and research activities is highly site-specific. A protocol that is manageable within one major research institution may place significant strain on a community-based clinic, or be unfeasible at a different major institution. A recruitment strategy that succeeds within a specialist center may be unsuitable in a regional setting. The assumptions that are made during feasibility assessments about trial execution are shaped by these differences. The emergence of the site economyThe most underappreciated reality in our industry is that sites operate within their own economy. Sites have finite resources and recruitment channels, and limited investigator time. Potential patients overlap across studies – the decision to pursue one protocol represents a decision not to pursue another. From a site’s perspective,study selection is an exercise in portfolio management. Historically, sites adapted to protocols. Increasingly, protocols must adapt to sites. Site teams continuously evaluate opportunities based on scientific interest, operational burden, recruitment potential, financial viability, and strategic fit. They assess not only whether a study can be conducted, but whether it should be conducted, relative to competing alternatives. This fundamentally changes how we think about study performance. If enrollment targets are missed, the explanation is often sought within site execution, yet many challenges begin prior to enrollment – the site choices about where to invest their attention and effort. Why the easiest study often winsThe clinical trial industry gravitates naturally toward scientific innovation; however, sites evaluate studies through an operational practicality lens. A protocol might investigate a highly promising therapy, but if eligibility criteria are overly restrictive, visit schedules/procedures/administration are burdensome, without a site support model, enrollment becomes more difficult. Investigators could still remain enthusiastic, but coordinators struggle to operationalize the study. Conversely, studies that are straightforward to explain, straightforward to execute logistically, and straightforward for patients to complete generate stronger engagement. The uncomfortable reality is:sites do not always prioritize the most compelling therapy. They prioritize the protocol offering easy execution. We frequently talk about patient-centricity in protocols; site-centricity must enter the discussion. Protocols or site support models failing to account for site operations risk creating friction ultimately affecting enrollment, retention, data quality, and success. The CRO’s balancing actSponsors focus on R&D objectives, regulatory requirements, timelines, and returns on investment. Sites focus on patient care, resource allocation, and local execution. CROs sit between these worlds. The most effective CROs do more than execute protocols – they translate the nuances to reconcile competing perspectives for sites before they become operational challenges. They provide sponsors with a clearer understanding of site realities, while helping the sites navigate increasingly complex requirements. The CROs best positioned for success are those capable of viewing protocol design not only through the lens of scientific rigor, but through execution feasibility, site support, and overall patient burden. From site management to site partnershipSite management implies a relationship in which sites are directed, monitored, and overseen, but this is an increasingly outdated perspective. Sites possess more choice than ever, and are not passive participants within the development process, but are active decision-makers. CROs achieving the greatest success are those moving beyond site management to site partnership, built on understanding incentives, reducing burden, incorporating feedback, and recognizing that successful study delivery depends on mutual success. Sites are not simply executing protocols; they are making continuous decisions about where to focus finite resources, decisions which ultimately shape development success. A different model of site enablementAs sites are increasingly operating within a resource-constrained environment, our support models must evolve. While much industry site engagement is built around startup, monitoring, and issue resolution, they do not address the broader operational pressures that influence site performance. The best approach is to provide sites with dedicated specialist support focused specifically on the site experience. Rather than adding additional oversight, these teams act as advocates, facilitators, and problem-solvers, navigating operational challenges, reducing administrative burden, and maintaining momentum through study lifecycles. In practice, this means engaging site stakeholders earlier and more meaningfully throughout study design. Protocol review must extend beyond scientific and regulatory considerations to include operational simulation (testing how procedures, visit schedules, data collection requirements, and technology workflows will function in real-world settings). Site advisory boards should include a broader range of trial participants, from investigators to study coordinators and operational personnel, who understand where burden accumulates during a study. Sponsors must challenge each endpoint, assessment, and datapoint – are they essential, or just “nice to have”?The opportunity for sponsors and CROsAny tension between sponsors and sites is not a sign of dysfunction, it is a natural consequence of differing incentives. Sponsors are rewarded for speed, data generation, and development efficiency. Sites are rewarded for sustainable operations and high-quality patient care. The CRO’s role is not to choose between priorities, but to align them. The most successful studies are rarely those that optimize exclusively for one stakeholder – they are those creating the conditions in which sponsor objectives and site realities reinforce one another. In a site economy, support is a form of investment. Sponsors and CROs investing in reducing site burden, accelerating problem resolution, and strengthening site relationships are effectively increasing the likelihood that sites will allocate their scarce resources to their studies. Success belongs not only to the study with the strongest science, but to the study that sites choose to champion. Sponsors and CROs must create protocols and operational environments that earn site commitment.