The practice-embedded site: what sets nephrology research at SCRI apart.

Three ways to run a kidney trial

Sponsors choose among three kinds of site. Academic centers bring depth and reputation, and slow contracting, local IRBs, and investigators whose clinics are one of many obligations. Commercial site networks and SMOs bring speed and standard operating procedures, and patients recruited by advertisement who have no relationship with the investigator. Practice-embedded sites are the third model: a research institute owned by a treating practice, drawing participants from that practice’s own patient panel, run by the physicians who see those patients in clinic.

Southeastern Clinical Research Institute is the third kind. It is owned by Nephrology Associates, PC, the largest private-practice nephrology group in the Central Savannah River Area, with seven offices and physicians who serve as medical directors of area dialysis centers.¹ The practice added its eighth physician in 2022; every SCRI investigator is a board-certified nephrologist on that staff.¹

What the model changes

1. The patient already exists

A CKD stage 3 patient with albuminuria on a maximally tolerated ACE inhibitor is not a billboard demographic. She is a chart. In a practice-embedded site the coordinator pre-screens the practice’s own population against the protocol’s inclusion criteria before the first advertisement is ever considered, and the invitation comes from the nephrologist she already trusts. ADPKD families, IgA nephropathy patients, and dialysis patients stay with one nephrology practice for years; here, they are already under the investigators’ care.

2. The investigator is the treating physician

Study visits happen alongside routine care, not instead of it. Adverse events are seen by the doctor who knows the patient’s baseline. Referring physicians hear back physician-to-physician, and their patient’s routine care continues in their office. The result sponsors care about is retention through long outcomes trials; the result physicians care about is that nobody loses their patient to a study.

3. One accountable team, CDA to closeout

SCRI runs as a single site with a dedicated regulatory specialist, dedicated budget and contract support, and a dedicated patient coordinator, all reporting to a Director of Research Operations with 20+ years of industry trial management.³ The sponsor’s central IRB is accepted; there is no local review to wait on. Investigators and coordinators meet in a weekly research meeting that covers every open study. The site has a CLIA-certified laboratory, on-site pharmacy management for investigational product, and a private monitoring room with its own restroom for visiting CRAs.

What it has delivered

The proof is in the trials themselves. SCRI’s investigators have served as site investigators on studies that changed the standard of care in nephrology, and the site is named on the public record for a run of the field’s defining programs:

• REPRISE, the tolvaptan trial in later-stage ADPKD that supported the first FDA-approved treatment to slow kidney function decline in the disease.^4,5
• DAPA-CKD, the dapagliflozin outcomes trial published in the New England Journal of Medicine, with an SCRI investigator among its authors, and the vadadustat anemia program, also NEJM-published with SCRI authorship.⁶
• FIND-CKD (finerenone in non-diabetic CKD) and ZEUS (ziltivekimab, cardiovascular outcomes in CKD with inflammation), both completed with Augusta as a listed site.^7,8
• ACCLAIM-Lp(a) and TRIUMPH-Outcomes, two of the largest cardiorenal outcomes trials now in follow-up, roughly 17,300 and 10,000 participants, with SCRI as a listed site for both.^9,10
• Three completed ADPKD programs, including the first-in-class anti-miR-17 study, which is the subject of our companion paper on polycystic kidney disease.²

Across the program: chronic kidney disease, diabetic kidney disease, IgA nephropathy and other glomerular disease, resistant hypertension, anemia and mineral-bone disease, dialysis drug and device studies, and polycystic kidney disease as a site specialty.²

For referring physicians

A practice-embedded site is the one kind that cannot afford to treat your patient as a subject. The investigators are your colleagues, the coordinators call your office, and the outcome of the screen comes back to you either way. If a patient of yours has CKD, hypertension, glomerular disease, or a family history of polycystic kidney disease, there may be a protocol for them here, and referring costs you nothing but a fax.

For patients

Because the doctor running the study is the doctor running your care. There is no cost to take part, your insurance is never billed, you can withdraw at any time without any change to your treatment, and every protocol is overseen by an Institutional Review Board. Research here is not separate from care. It is an extension of it.

Ask if a study fits me → Refer a patient