Can My Medical Practice Participate in Clinical Research?

If you’ve never participated in a clinical trial, it’s easy to assume that research is something that happens primarily at academic medical centers, large hospitals, or dedicated research facilities.

But community physicians and medical practices can play an important role in clinical research. And you don’t necessarily need previous research experience—or an established research department—to get started.

The better question isn’t, “Are we already a research site?”

It’s “Could our practice be a good research site?”

For many practices, the answer may be yes.

What Makes a Medical Practice a Potential Research Site?

Every clinical trial has different requirements, so there isn’t one checklist that determines whether a practice can participate in research.

Sponsors—the pharmaceutical, biotechnology, or medical device companies conducting clinical trials—look at a number of factors when evaluating potential research sites.

One of the most important is your patient population. If your practice regularly treats patients with the condition being studied, you may have access to exactly the population a sponsor is trying to reach.

Your specialty and clinical expertise matter as well. Sponsors need qualified investigators who understand the disease or condition being studied and can provide appropriate medical oversight of trial participants.

Other considerations can include your practice setting, available facilities and equipment, access to laboratory or imaging services, staff resources, and your ability to follow the requirements of a particular study.

But you don't need to have all of those pieces figured out before exploring research.

That comes later.

Do I Need Previous Clinical Research Experience?

Not necessarily.

An experienced physician may have spent years treating patients in a particular therapeutic area while having little or no experience with the operational side of clinical trials.

Those are two very different kinds of expertise.

Clinical research introduces processes and terminology that may be unfamiliar at first: Institutional Review Boards (IRBs), study protocols, informed consent requirements, regulatory documents, sponsor monitoring visits, electronic data capture systems, investigational product accountability, and more.

That can make research appear intimidating to a practice considering its first trial.

But physicians don't have to become experts in every aspect of clinical research operations before they can participate. An experienced research team can provide much of the infrastructure and operational support needed to conduct a study.

Do I Need to Hire a Clinical Research Coordinator?

Clinical trials require considerably more coordination and documentation than ordinary patient care.

A clinical research coordinator (CRC) often manages much of the day-to-day activity involved in conducting a trial. Depending on the study, that may include coordinating patient visits, maintaining study documentation, communicating with sponsors, entering study data, tracking required procedures, preparing for monitoring visits, and helping ensure the site follows the protocol.

That doesn't necessarily mean your practice needs to hire and build its own research department.

Some practices choose to develop an internal research team. Others work with a Site Management Organization (SMO) that provides research personnel, systems, regulatory support, study management, and other infrastructure needed to conduct clinical trials.

For a physician who is new to research, this can significantly reduce the operational burden of getting started.

What Would My Responsibilities Be as the Physician?

Research support does not eliminate the physician's responsibilities.

The physician serving as the Principal Investigator (PI) is ultimately responsible for the conduct of the clinical trial at the research site.

Among other responsibilities, investigators must provide appropriate oversight, protect the rights and welfare of research participants, follow the study protocol, complete required training, appropriately document study activities, and ensure that the trial is conducted according to applicable requirements.

Those responsibilities are important—and they cannot simply be handed off to someone else.

But that doesn't mean the PI has to personally perform every administrative task associated with the study.

A strong research team supports the investigator by managing much of the operational work surrounding the trial.

The goal isn't to replace the physician as investigator. It's to allow the physician to focus on the responsibilities that truly require the investigator while experienced research professionals manage much of the work around them.

How Does a Practice Get Selected for a Clinical Trial?

Clinical trials don't simply arrive at a medical practice.

Sponsors and the Clinical Research Organizations (CROs) working on their behalf identify potential investigators and research sites for individual studies.

A practice may be asked to complete a feasibility assessment, which helps determine whether the site is a good fit for the trial.

The sponsor may evaluate factors such as your clinical experience, patient population, anticipated number of eligible participants, competing studies, available facilities, research staff and ability to meet the protocol's requirements.

For physicians working with an SMO, the SMO may also help identify potential studies, develop relationships with sponsors and CROs, respond to feasibility opportunities, and prepare the practice for the site-selection process.

Being interested in research doesn't mean every clinical trial will be right for your practice—and it shouldn't.

The goal is to find studies that are appropriate for your patients, your practice, and your physicians.

What Happens If We're Interested?

Exploring clinical research doesn't require committing to a clinical trial.

A good first step is simply determining whether research makes sense for your practice.

That conversation might include your specialty, patient population, areas of clinical interest, practice structure, available resources, and how involved you would like to be in building a research program.

From there, you can determine what additional infrastructure or support would be needed and what types of clinical trials might be a good fit.

For some practices, the opportunity may be immediate. For others, finding the right study may take time.

Either way, you don't need to build a research department before you start the conversation.

Curious Whether Clinical Research Could Work in Your Practice?

Altitude Clinical Research works with physicians and medical practices interested in exploring clinical trial opportunities. We provide the operational infrastructure and research expertise that can help practices participate in clinical research without having to build an entire research program on their own.

You don't need to already be a research site. You just need to be interested in exploring whether research is right for your practice.

Talk with the Altitude Clinical Research team about your practice.