Many physicians assume that running a clinical trial requires a research building, a large coordinating office, and a separate administrative structure that only academic centers can sustain. That perception can make research feel out of reach for community and private practices, even when clinical interest is strong. 

The reality is often very different. For most practices, the biggest barriers to getting started are operational, not clinical. The questions are less about whether physicians have the expertise to care for participants and more about how to support the documentation, scheduling, and regulatory work that sits alongside routine care. 

Misconception #1: “Our team can absorb research work alongside routine care”

It is common for trial naïve practices to imagine that existing nurses, medical assistants, or physicians can simply add research responsibilities to their current roles. On paper, tasks like data entry, query resolution, protocol specific scheduling, and preparation for monitoring visits may seem like incremental additions.

In practice, these responsibilities behave more like a second job. Each protocol visit generates documentation in the electronic data capture system, follow up on data queries, tracking of visit windows, and preparation for sponsor monitoring. When there is no defined owner and no protected time, research tasks tend to fall to the end of already long days, which increases the risk of burnout, backlogs, and errors.

Successful sites treat research coordination as a distinct function, even when they start small. That does not necessarily mean hiring a large team. It does mean ensuring that there is clear responsibility and time for the operational engine of the trial.

Misconception #2: “We need major infrastructure investments”

Another common belief is that clinical research requires extensive remodeling or new technology systems. In reality, many foundational needs can be met with incremental adjustments to existing space and tools.

Exam rooms that already support patient visits can be scheduled for trial visits, provided there is sufficient privacy for informed consent discussions. Secure storage for investigational products or lab kits often takes the form of lockable cabinets and validated thermometers rather than new construction. Many electronic health records can serve as compliant source documentation systems when configured with appropriate templates, signatures, and access controls.

Where specialized equipment is required, it is usually limited and can often be supported through study budgets or external coordination support instead of large capital projects.

Misconception #3: “We need a full research department”

Physicians sometimes picture an entire research office with multiple coordinators, regulatory staff, and data managers before they can host even a single trial. This can be discouraging for smaller practices.

Regulations are clear that the investigator is responsible for participant safety, eligibility assessments, informed consent, and medical decisions. Those responsibilities cannot be delegated away. However, much of the day-to-day operational work can and should be supported by a research coordinator and study team.

A focused model that combines clear investigator oversight with dedicated coordination support is often sufficient for early trials. As experience grows, practices can expand their research footprint in step with their comfort and capacity rather than building a large department upfront.

What Sponsors Actually Look For

From the sponsor perspective, three factors tend to matter most: the available patient population, the engagement of the investigator, and operational readiness.

They need to know that your practice sees enough of the relevant condition to meet realistic enrollment targets. They look for investigators who are committed to protocol adherence, timely safety reporting, and high-quality data. And they assess whether your site can support reliable scheduling, documentation, and compliance, either through internal resources or external site enablement support.

You do not need to look like an academic center to meet these expectations. You do need a clear plan for how clinical and operational roles will work together.

A Practical Starting Point

Many institutions find it helpful to begin with observational or registry studies that align closely with routine care. In these designs, patients receive standard treatment while the team prospectively collects structured data on outcomes, safety events, and resource use. The primary changes involve documentation habits and consent procedures rather than complex interventions.

From there, lower complexity interventional studies, such as Phase IV trials or protocols that mirror routine follow up for chronic conditions, often provide a manageable next step. They allow teams to gain experience with investigational products and more structured visit schedules without overwhelming clinic operations.

Conclusion

Most practices are closer to research readiness than they realize. The key is recognizing that the hardest problems are operational, not clinical, and that physicians do not need to become research administrators to offer trials to their patients.

In our next article, “How Community Practices Can Launch Their First Clinical Trial Without Disrupting Patient Care,” we will walk through a step-by-step pathway from initial interest to first patient enrolled.

To learn how Milestone One can support you in navigating complexity, taking on additional studies, or getting started with research for the first time, reach out to the Milestone One team.