Hub-and-Spoke Clinical Trial Site Networks

A hub-and-spoke clinical trial site network pairs one experienced, typically academic, “hub” site with several smaller “spoke” sites — often community hospitals, clinics, or physician practices — that recruit and see participants closer to where they live. The hub holds the primary investigator relationship, protocol expertise, and much of the trial infrastructure; the spokes extend geographic and demographic reach without each one having to independently stand up full trial capability. It is a structural model for organizing where trial activities happen and who is accountable for them — distinct from, though sometimes combined with, the technology- and modality-focused changes associated with decentralized clinical trials (DCTs).

What defines the hub-and-spoke model

In a hub-and-spoke network, the hub is usually an academic medical center or established clinical trials unit with an experienced principal investigator (PI), regulatory infrastructure, and sponsor-facing accountability. Spokes are affiliated sites — community oncology practices, regional hospitals, federally qualified health centers, or satellite clinics — that conduct some or most in-person study visits under delegated authority from the hub PI, coordinated through sub-investigators and site staff trained to a common protocol.

The division of labor varies by trial and therapeutic area, but a common pattern is: the hub retains protocol ownership, central data review, and the primary sponsor relationship, while spokes handle local recruitment, screening, and routine visits, escalating complex assessments or interventions back to the hub. This is the structural pattern reported in oncology settings, where major cancer centers act as hubs coordinating with community-based clinics as spokes to widen access to trials that would otherwise be concentrated at a small number of large centers (see the Healio coverage of hub-and-spoke initiatives in blood cancer trials). Publicly documented network structures with a broadly comparable lead-site/affiliate-site logic include the National Cancer Institute’s Community Oncology Research Program (NCORP), which links academic research bases with community-based sites to deliver cancer trials outside major research centers — useful as a real-world reference point for how a lead site can extend delivery capacity, though NCORP’s own governance details differ from any single sponsor-run hub-and-spoke design and should be verified against NCI’s own program materials rather than assumed to map one-to-one onto a commercial trial.

Why sponsors and hub sites adopt it

Broader, more representative enrollment. Spokes situated in community settings can reach participants — by geography, race/ethnicity, socioeconomic status, or distance-to-travel — who are underrepresented at large academic medical centers alone. This is a frequently cited rationale for hub-and-spoke oncology networks specifically, per the coverage cited above.
Faster, more resilient recruitment. Multiple spokes screening in parallel can accelerate enrollment relative to a single site, and spread risk if one site underperforms or is disrupted, without each spoke needing independent full-scale trial infrastructure.
Leverage of scarce PI and specialist expertise. A hub PI’s protocol knowledge and clinical judgment can extend to more participants than that PI could see personally, with spoke clinicians handling routine visits under delegation and escalating complex cases.
Lower per-site standup cost than independent full sites. Spokes typically don’t need to replicate the hub’s full regulatory, monitoring, and data-management infrastructure, which can make the model more cost-efficient than opening additional fully independent sites for the same enrollment target — though this has to be weighed against the coordination and oversight cost discussed below.
A middle path between one site and full decentralization. Hub-and-spoke keeps in-person, higher-complexity visits anchored at physical locations (the hub or a spoke) rather than eliminating site visits altogether, which can suit trials involving procedures, infusions, or assessments that are difficult to fully decentralize.

Operational considerations

Staffing and training consistency

Because spoke sites are often smaller and may have less dedicated research infrastructure than the hub, maintaining a consistently trained, protocol-competent staff across every spoke is a recurring operational burden. Sponsors and hub coordinating teams typically need a standardized training and re-certification program, clearly documented delegation of authority (who at each spoke is authorized to perform which study procedures, tracked via a delegation log under the hub PI), and a plan for staff turnover at spokes, which tends to be higher at smaller community sites than at an established academic Clinical Trials Unit (CTU).

Data consistency and quality

Uniform data collection across sites of varying size and infrastructure is a core challenge. Networks generally rely on a shared electronic data capture system reaching every spoke, standardized source-document and case-report-form conventions, and central data review at the hub to catch site-to-site drift early. This is one area where ALCOA+ data integrity principles and the audit-trail/access-control requirements of 21 CFR Part 11 apply with particular force: a spoke’s data has to be as attributable, contemporaneous, and complete as the hub’s, even though it may be collected by staff with less trial-specific experience.

Monitoring

Hub-and-spoke networks commonly combine on-site monitoring visits to individual spokes with centralized monitoring run from the hub or sponsor, reviewing aggregated data across all spokes to flag outliers, protocol deviations, or enrollment issues that a single-site view would miss. This blended approach is consistent with the risk-based monitoring (RBM) approach described in ICH E6, which directs monitoring intensity toward the risks most likely to affect participant safety and data reliability rather than mandating uniform on-site visit frequency at every location. ICH’s current core Good Clinical Practice guideline, ICH E6(R3) — finalized January 2025, with the EU’s effective date of 23 July 2025 for the Principles and Annex 1, and FDA’s own final E6(R3) guidance issued 8 September 2025 — places explicit emphasis on data governance and risk-based quality management, which maps directly onto the oversight burden a multi-spoke network carries.

Regulatory and ethics oversight

Multi-site networks in the US commonly rely on a central or single IRB (sIRB) covering the hub and its spokes under a reliance arrangement (for federally funded research, often formalized through a mechanism such as a SMART IRB reliance agreement), rather than each spoke maintaining its own local IRB review. This reduces duplicate review but requires the hub to manage a single set of protocol amendments, consent versions, and reportable-events processes that every spoke must follow consistently — coordinated in practice through the hub’s Clinical Trials Office (CTO) or equivalent central administrative function.

Technology and infrastructure

A functioning network typically needs shared systems that every spoke can access reliably: electronic data capture, eRegulatory document management, and often a shared central laboratory or imaging read to keep results comparable across sites rather than dependent on each spoke’s local lab. Smaller spokes may lack in-house IT support for these systems, which is a practical planning point the hub coordinating team has to account for, not just a protocol-design question.

How hub-and-spoke differs from fully decentralized (virtual) trials

Hub-and-spoke and decentralized clinical trials (DCTs) are frequently discussed together because both aim to widen trial access beyond a single academic center, but they solve that problem differently. Hub-and-spoke redistributes trial activity across a network of physical sites — the hub plus its spokes — coordinated under one PI and one regulatory framework; participants still generally visit a brick-and-mortar location, just one closer to home than the sole hub would be. A fully decentralized or virtual trial, by contrast, shifts activities away from any investigational site altogether where feasible — telehealth visits, local labs or home health visits, direct-to-participant drug shipment, wearables and remote data capture — as described in CASRAI’s Decentralized Clinical Trials (DCT) entry and compared in detail in Centralized vs. Decentralized Clinical Trials: How to Choose the Right Model.

The two models are not mutually exclusive. A network can be organized hub-and-spoke and incorporate decentralized elements — for example, a spoke site supplemented by telehealth follow-up visits, or a hub that ships investigational product directly to participants between in-person spoke visits. FDA’s September 2024 final guidance, Conducting Clinical Trials With Decentralized Elements, addresses this kind of blended design directly, covering how remote and community-based trial activities — including those conducted at sites other than the traditional investigational site — can be implemented within a compliant regulatory framework; it does not require an all-or-nothing choice between a site-based network and a fully virtual trial. For challenges and risks that apply once decentralized elements are layered onto any site model, see CASRAI’s guide on Challenges and Risks of Launching a Decentralized Clinical Trial.

Common challenges and risks

Protocol drift between hub and spokes. Without disciplined central training and monitoring, spoke-level interpretation of protocol procedures can diverge over time, especially in longer trials.
Uneven enrollment performance across spokes. Not every spoke will screen and randomize at the same rate; networks need a plan for reallocating enrollment targets or providing additional support to underperforming sites rather than assuming uniform output.
Coordination overhead at the hub. The hub PI and coordinating team carry real administrative burden — training, delegation oversight, central data review, sponsor communication — that scales with the number of spokes and has to be resourced explicitly, not treated as incidental to running the hub’s own patients.
Spoke-site capacity limits. Community sites may have limited research staff, competing clinical demands on the same personnel, or thinner infrastructure for handling investigational product storage, adverse event reporting, or audit readiness than an established academic CTU.

Frequently asked questions

What is the hub-and-spoke model in clinical trials?

It is a site-network structure in which one experienced “hub” site — usually an academic medical center with a principal investigator and established trial infrastructure — coordinates with multiple smaller “spoke” sites, such as community clinics or hospitals, that conduct trial visits closer to where participants live, under delegated authority and shared protocol, data, and oversight systems managed by the hub.

How is hub-and-spoke different from a fully decentralized (virtual) trial?

Hub-and-spoke still relies on physical investigational sites — the hub and its spokes — coordinated under one regulatory and data framework, whereas a fully decentralized trial shifts activities away from any investigational site where feasible (telehealth, home visits, direct-to-participant drug shipment). The two approaches can be combined: a hub-and-spoke network can incorporate decentralized elements at individual spokes.

Who is responsible for regulatory compliance across the network?

The hub PI typically holds primary regulatory accountability, with spoke-site staff operating under delegated authority documented in a delegation log. Multi-site US networks commonly use a central or single IRB (sIRB) covering all sites under a reliance arrangement rather than separate local IRB review at every spoke.

How is data quality maintained across spoke sites with less research infrastructure than the hub?

Through a shared electronic data capture system used by every site, standardized source-documentation conventions, and centralized data review at the hub that can flag site-to-site inconsistencies early, supported by risk-based and centralized monitoring rather than relying solely on periodic on-site visits.

What kind of trials tend to use a hub-and-spoke network?

The model is commonly reported in therapeutic areas where a relatively small number of academic centers hold most of the specialist expertise but the eligible participant population is broader and more geographically or demographically dispersed than those centers alone can reach — oncology is the most frequently documented example in published coverage of the approach.

Related CASRAI resources

This page reflects general, published patterns in how hub-and-spoke clinical trial networks are structured and operated, drawn from public reporting, program documentation, and current ICH/FDA guidance. It does not describe any single sponsor’s or institution’s specific network design.