Adding clinical trials to a medical practice: the business case

Why do practices make strong research sites?

• Speed. Physician practices reach first patient in faster than other site types in Tufts CSDD's startup benchmarks (Applied Clinical Trials).
• Patients already in care. Sponsors look for sites that bring new patient populations (Bourne Partners), and a practice's panel is exactly that.
• Physician credibility with patients and with referring colleagues.

What does it take?

1. An investigator who commits time. For drug studies under an IND, the investigator signs Form FDA 1572, committing to conduct the study per protocol and regulation (FDA).
2. A dedicated coordinator, not a medical assistant squeezing research between clinic visits.
3. SOPs, GCP training, and quality systems.
4. Separation of research and clinical billing, so research procedures are billed to the sponsor and routine care follows coverage rules. See coverage analysis.
5. Working capital: sites at SCRS recommended at least three months on hand (Bourne Partners).

What does the revenue look like?

Sponsors pay per completed visit and procedure, plus startup and invoiceable fees. Revenue follows enrollment, so a study that enrolls two patients rarely covers its startup work. 37% of sites have under $1 million in gross revenue (SCRS), and many practices start smaller still. Over time, buyers value practice based sites on EBITDA like any other site (Objective IBV).

How should a practice start?

• Pick one therapeutic area the practice already treats in volume.
• Take one study, enroll it well, and use that record to win the next.
• Use the revenue per patient calculator before signing each budget.

Where do patients come from beyond the practice?

A single practice's panel runs dry for most protocols. The next source is colleagues: other practices in your specialty and primary care physicians nearby who see eligible patients but refer less than 0.2% of their patients into trials today (Tufts CSDD). A practice that informs them systematically extends its reach without adding locations.