Bring Clinical Research Into Your ASC

Here's my roadmap to the likely obstances and how to overcome them.

Robert J. Weinstock, MD

Ophthalmology Management July 1, 2025 Page(s): 4, 5, 6, 7, BC

Clinical Scorecard: Bring Clinical Research Into Your ASC

Category	Detail
Condition	Clinical trials in Ambulatory Surgery Centers (ASCs)
Key Mechanisms	Conducting clinical trials to introduce innovative surgical devices and techniques, requiring contract customization, operational planning, and staff engagement
Target Population	Ophthalmologists and ASC staff involved in surgical clinical trials
Care Setting	Ambulatory Surgery Centers (ASCs)

Clinical trials elevate ASC status as innovation centers and boost staff engagement.
Customized contracts reflecting ASC-specific costs are essential to avoid financial loss.
Operational planning and staff buy-in are critical to accommodate workflow changes and additional trial requirements.

Perform due diligence to confirm clinical trials are permitted at the ASC.
Investigate processes and regulations including FDA protocols and Institutional Review Board standards.

Negotiate trial contracts to reflect ASC-specific costs including staff time, supplies, and logistics.
Plan surgical schedules to accommodate additional time for trial-related tasks such as consent forms and surveys.
Ensure logistics support including locked storage and refrigeration for trial devices and supplies.

Maintain robust accounting and inventory oversight for trial materials.
Allocate additional staff time for trial-specific monitoring tasks, e.g., frequent postoperative checks.

Generic contracts may lead to financial losses due to unaccounted costs.
Insufficient staff training and buy-in can cause workflow disruptions and resistance.
Lack of infrastructure for device storage and regulatory compliance may impede trial conduct.

Patients undergoing surgical procedures in ASCs participating in clinical trials

Clinical trials often involve novel devices and specific perioperative regimens requiring additional resources and monitoring.

Engage in detailed contract negotiations to ensure appropriate compensation and cost allocation.
Communicate clearly with staff about trial purpose and patient benefits to foster buy-in.
Build long-term infrastructure including trained staff and protocols to facilitate future trials.
Collaborate between surgeons, clinical research coordinators, and ASC personnel for training and workflow integration.