What Happens When Clinical Trial Patients Need Care Outside Of The Study?

By Rita Birdi, BSc., EMBA

Imagine a clinical trial participant arrives at the emergency department. They might be experiencing an adverse event. Or maybe their symptoms have nothing to do with the clinical trial at all. They might be seriously ill, scared, and in pain, and on top of that, they might not be able to communicate clearly or at all.

The emergency team needs to make decisions quickly. They have questions: What medication are they taking? Are there relevant interactions or restrictions? Is there anything that may negatively impact them right now?

The patient may know that they are participating in a clinical trial, but they may not remember the name of the drug product or important protocol details. If they can’t recall the details, their family member may know even less. There may be a patient card with the study contact information, but is it in their wallet? Does their spouse have it? Is it updated, and can the study team be reached quickly enough?

Meanwhile, the emergency team still has a patient in front of them who needs care.

Clinical Trials Don’t Exist In Isolation

This emergency team is part of a broader “external care team,” which refers to any physician, hospital team, emergency department, urgent care clinic, or other healthcare provider treating a participant outside the clinical trial.

After more than 25 years working in clinical operations, I have seen versions of this problem with external care teams repeatedly. We have built sophisticated infrastructure around clinical trials, but when a trial participant temporarily steps outside that system and seeks external care, a disconnect reveals itself: the healthcare vs. trial care information gap.

The patient moves between two medical care environments, and the information needed to connect those environments does not necessarily move as easily between the two. And during active treatment, that gap can really matter, for both the safety of the patient and the data for the sponsor.

Care Teams Treat Patients Based On Incomplete Information

Clinical trials are highly controlled environments by design, but participants do not live only inside that infrastructure. Between site visits, they might be treated by an external care team that likely has no relationship with the investigator, sponsor, or CRO.

In an emergency, the treating physician’s first responsibility is to assess, stabilize, and treat a patient. If the physician fails to consider clinical trial protocols while treating the patient, it’s likely they simply do not have the context. They make clinical decisions using information readily available to them, and that may be entirely appropriate and without consequence.

However, clinical trial participation can complicate treatment. For example, a treatment could complicate the interpretation of a safety event, or a new treatment could force discontinuation of the investigational treatment.

The Consequences Are Many

This information gap between clinical care and clinical research operations risks patient safety, trial operations, and data integrity. From a safety perspective, the treating team may need to understand something about the investigational treatment or study restrictions that could influence clinical decision-making. From an operational perspective, unexpected external care can create additional follow-up, safety assessments, inspection storyboards, and communications across the site, sponsor, and CRO. And from a data perspective, certain medications or interventions can complicate interpretation of outcomes and permanently exclude the patient from study treatment. That most dire effect could mean months or years of commitment and, for some patients, hope.

The Patient Becomes The Bridge — But Not A Sturdy One

We have mechanisms intended to close the information gap. Depending on the trial, participants may receive patient identification cards; emergency contact information; study information; instructions for how to contact their investigator, study site, or a safety call center; and/or education about medications or treatments they should avoid. These are important safeguards, but they also depend heavily on the patient carrying that information from one system into another.

In some situations, that works, but in others it may not. A patient may be extremely unwell, unconscious, or confused. They may not speak the same language as the treating team. They may know they are participating in a study without remembering the name of the investigational product. Even patients who understand their study well may struggle to communicate complex information during a medical emergency. Caregivers may know that their loved one is participating in research but not much more. At one of the most vulnerable moments for a patient, the patient must be the bridge between two complex systems.

The Information Gap Affects Both Sides

Information needs to travel from the clinical trial to the external health care provider — and it may also need to travel back. If a participant receives a medication, undergoes a procedure, or experiences another medically significant event, the investigator may need that information quickly.

The study team may need to understand what happened, when it happened, what treatment the care team provided, and whether the participant’s treatment or participation overall is affected.

This creates a two-way information gap: The first can influence treatment decisions, and the second can influence safety assessment, protocol management, and study data.

Historically, we have understandably focused on how to keep clinical trial information secure within the clinical trial ecosystem. Perhaps we now need to ask what protocol-critical information should follow a participant into the clinical care ecosystem and how efficiently the information about that external encounter travels back to the trial team.

What Happens Next?

After the external care treatment occurs, ideally, the site learns about the event from the treating team, the PI assesses what occurred, and the sponsor or CRO safety reporting team evaluates the event. The full impact on the patient’s continued participation is assessed. All these processes are necessary, but note that they only occur after the care has already been delivered.

Clinical research has developed sophisticated systems for documenting, evaluating, and responding to events if they occur. What would be useful is to provide improved access to trial information at the point of care to prevent downstream consequences.

An Interesting Moment For Clinical Research

While not addressing this specific issue, there are several ongoing efforts that may have implications for harmonizing clinical care and research. For example, the FDA’s guidance on DCTs (Decentralized Clinical Trials) recognizes that trial-related activities may take place outside of the traditional research sites, including through external care teams. FDA guidance also addresses how adverse events requiring urgent or in-person attention should be managed in decentralized trials. At the same time, regulators are exploring ways to integrate RCTs (Randomized Controlled Trial) into routine clinical practice by using established healthcare institutions and existing clinical expertise. In parallel, healthcare and clinical research systems are becoming more interoperable, with standards such as HL7 FHIR encouraging the connection of EHRs and clinical research systems.  (HL7 FHIR is a universal set of rules and formatting guidelines that allows different healthcare computer systems to easily share patient data with each other. The FDA is actively creating official implementation pathways to allow pharmaceutical companies and researchers to submit data using the FHIR format).

All of these together raise an important question: How can we increasingly bring the clinical trial into traditional healthcare settings if we are not already equally modernizing how trial context follows those patients outside a study?

Why Does This Gap Still Exist?

There are some legitimate reasons why clinical trial information is not broadly accessible.

• Patient privacy must be absolutely protected.
• Study blinding must be maintained.
• Access to protocol-specific information, investigational product details, and relevant participant information must be restricted to appropriately authorized individuals.

Any trial-related information available to external treating healthcare professionals, including relevant medication restrictions, investigational product safety considerations, and study contact details, must be accurate, current, and consistent with the applicable protocol and safety information. This information, as well as regulatory and cybersecurity requirements, have to be respected and maintained. And critically, any mechanism intended to support external physicians must not create confusion or interfere with their independent medical judgment. But complexity is not a reason to stop asking whether the current approach is enough.

Building A Better Bridge

For more than 25 years in clinical operations, I have watched our industry become increasingly sophisticated at managing what happens inside a clinical trial. That progress is remarkable, but patients do not experience healthcare in a controlled way.

To the patient, there is no clinical trial ecosystem and external healthcare ecosystem. There is only healthcare, and our systems create the boundary. And when a patient crosses that boundary during active trial participation, we should ask whether the information necessary to protect both their care and their participation crosses with them.

Patient cards and emergency contacts remain valuable tools, but in an era of increasingly complex protocols, investigational therapies, and clinical trial digitization, we can do more. We need continuity of trial context wherever the participant happens to receive care. We need the information architecture to evolve.

Perhaps the next important innovation in clinical trials will not be another system that manages what happens inside the study, but one that helps protect the patient when they step outside it.

About The Author:

Rita Birdi is a clinical operations leader with more than 25 years of experience in trial delivery across pharma, biotech, and clinical research. She is passionate about improving clinical trial delivery, advancing operational excellence, and exploring how emerging technologies can transform the industry. She is also the founder of Well-Paid & Well-Being (WPWB), helping women in pharma and biotech recognize their professional value, communicate their impact, and build careers that reflect their experience and ambitions without sacrificing their well-being. With a background in nutritional anthropology and behavior change, she advocates for the connection between employee well-being, effective leadership, and organizational performance.