How to Refer a Patient for a Clinical Trial While Preserving Continuity of Care

Set expectations with the patient

Explain why a trial review may be appropriate and what remains unknown. A useful framing is: “I would like a research team to review whether a study may fit your medical situation. The review may require more records and screening, and it does not guarantee that you can enroll.”

Discuss reasonable alternatives and whether a delay in standard treatment is medically acceptable. Patients should know whom to call while the review is pending and should not stop prescribed therapy without clinician guidance.

Send a referral that answers the first clinical questions

A referral is most useful when it includes:

• •Diagnosis, histology, stage, and current disease status
• •A dated sequence of systemic therapies, radiation, surgery, and significant responses or toxicities
• •Pathology and operative reports
• •Molecular profiling, biomarker, and germline reports when relevant
• •Recent imaging reports and access to images if needed
• •Recent laboratory results and performance status
• •Current medications, anticoagulation, corticosteroids, and important comorbidities
• •Active symptoms or complications
• •The proposed next standard treatment and the decision deadline
• •Direct contact information for a clinical question

A one-page treatment summary is valuable even when the complete chart is transferred. Highlight nuances that may not be obvious in a medication list, such as intolerance, progression date, unresolved toxicity, or a prior investigational agent.

Separate preliminary review from formal screening

The receiving site can compare the available record with major protocol criteria, but formal eligibility may depend on central pathology, a protocol-specified laboratory, imaging review, washout periods, a fresh biopsy, or findings at a screening visit. Cohort status and slots may also change.

Communicate this distinction to the patient. It reduces the risk that a request for records or an appointment will be interpreted as enrollment.

Define the communication pathway

At the time of referral, identify how and when information should return to the treating practice. High-value communication points include:

• •Receipt of the referral and missing items
• •Whether a protocol warrants formal screening
• •Consent and screening status when authorized
• •Enrollment and treatment start
• •Clinically significant safety events or changes that affect shared care
• •Study treatment discontinuation and transition plan

The exact communication must follow patient authorization, protocol requirements, and applicable privacy rules. Direct clinician-to-clinician contact is especially valuable when a time-sensitive judgment or complex toxicity is involved.

Clarify clinical ownership

Before treatment begins, the patient should know which team manages:

• •Investigational product administration and protocol procedures
• •Adverse events and after-hours study concerns
• •Routine cancer-related needs not defined by the protocol
• •Chronic conditions and primary care
• •Emergency evaluation and communication back to the study team

Research participation creates shared responsibilities. Clear ownership helps prevent duplicated tests, conflicting advice, or delayed symptom reporting.

Plan the return pathway

Continuity matters even when the patient never enrolls. The referring physician should receive a clear outcome when possible: not currently eligible, additional information needed, screening underway, patient declined, or study unavailable. If study treatment ends, the transition should address timing, unresolved adverse events, ongoing follow-up, and the next clinical decision.

Our FCTG referral model

At FCTG, our research-focused oncology team works alongside referring physicians rather than replacing their role in the patient's broader care. Our research staff organizes the initial protocol comparison, and our physician investigators review the clinical context and study-specific requirements. For potentially relevant studies, our investigators can communicate directly with the treating oncologist, when authorized, to support timing, continuity, and an appropriate transition plan. Availability and communication pathways depend on the specific study and patient authorization.