Performing clinical trials is a very important role and a priority for many ophthalmologists. They allow us to participate in bringing valuable surgical devices to market—such as implants, OVDs, surgical equipment, and new glaucoma implants, to name just a few. But while many physicians are well-versed with performing clinical trials in the
practice setting, where there is a dedicated clinical research assistant and staff allocated for the
trials, transitioning them into the ASC is a whole different animal.

So, why bother? As someone who has performed many clinical trials in ASCs, I can attest that doing so offers many benefits. It allows the ASC to position itself as a leading center for new and innovative techniques and devices. It also allows the staff to take pride in what they offer patients and to feel that they are contributing to the field of science. Given these meaningful rewards, bringing clinical trials into your facility is well worth the effort. 
What follows is my guide to the obstacles you will likely encounter and tips for overcoming them.

First, Customize the Contract

The financial contracts for performing clinical trials tend to be generic, so expect to engage in negotiation with the company to arrive at a contract that is tailored to your ASC’s situation. In fact, negotiation is a must, because a customized contract is a major factor in whether the trial turns out to be a financial boon or a liability for the ASC (See “When to Haggle,” back cover). The facility’s leadership needs to be prepared to collaborate to customize a contract—and to start all over again for any future clinical trials. To ensure the ASC benefits, the contract must be unique from trial to trial.

Budget Deep Dive

A properly structured contract with discrete allocated funds earmarked for the surgery center help make it a profit center. On the other hand, if the contract is not structured properly, the clinical trial will more likely cost the ASC money in resources, staffing, time, and additional instrumentation and products. So, the budget of the clinical trial requires a deep dive. Leadership should focus on how the payments are made, and to whom they are made.

Teasing Out the Costs

Let’s say you enter a clinical trial for a novel intraocular lens (IOL). Oftentimes the clinical trial protocol will call for a specific preoperative drop regimen, a specific VISCO elastic device, specific postoperative drops immediately after the surgery as well as other nuanced surgical maneuvers and devices. However, the supplies may not be readily available in the surgery center or may have additional costs to the surgery center over what is used in a standard procedure.
These costs must be accounted for. Customize the clinical trial agreement to reflect them and potentially have the clinical trial sponsor or budget additional fees for their usage.

In some cases, the clinical trials contract is written such there is just a single global fee for participating in the study. If this applies to the contract you are offered, the ASC and the clinic need to take a detailed approach of teasing out what the additional cost of performing the study will be and amend the contract or counter with a separate agreement. This agreement should reflect how much of the fee will go to the ASC and how much will go to the clinic.

Time is a Cost, Too

It is crucial to factor in the additional time involved in the clinical trial and how it will impact the flow of a surgical day. There are additional forms that need to be completed, consents and surveys that must be filled out immediately after the procedure—among other deviations from a routine surgery. So, it’s very important that the ASC budgets time into the planning of the surgical schedule to account for these additional tasks as well as the other resources needed.

Negotiations over various costs don’t have to be overly complicated or involve attorneys. However, they do require that in-depth investigation and often plenty of the back-and-forth between the company doing the trial and the site I’ve detailed.

Logistics

Logistics in the surgery center are also an issue when considering undertaking a clinical trial. Many of the devices require locked storage; some items require refrigeration. Can your facility accommodate them? 
Robust accounting and inventory oversight are also necessary, but often the ASC does not have the personnel to help with these tasks. Clinical staffing is certainly a challenge when a fast-paced ASC is already stretched thin. Be sure to factor in these potential issues before committing to a contract.

 Surgeons, Look Before You Leap

Surgeons who participate in clinical trials involving a surgical device are often very innovative and ambitious. But I’ve found it is common for these surgeons to not fully take into account what participation entails. Before engaging in a clinical study, surgeons need to perform their due diligence to make sure clinical trials are allowed at the surgery center in question, and investigate the processes and regulations around such trials.

Learn New Protocols

It’s likely that additional training on US Food and Drug Administration (FDA) protocols, Institutional Review Board standards, etc, will be necessary in the event ASC staff and surgeons are not already familiar with them. The clinical research coordinator as well as the surgeon should carve out time to meet with the personnel of the ASC and provide an overview of the clinical study as well as any training needed in handling the surgical devices. 
This training should take place well in advance of the surgical day. Often it is provided by the sponsoring company. While it usually doesn’t require more than a couple hours of staff’s time, it is very helpful in relieving the anxiety of doing something new when it comes time to perform the procedure.

For example, some protocols involve masking the surgeon and the patient from the particular device being used. In this situation, training for the surgery center staff would involve teaching them how to perform and communicate without giving away any information during the procedure that would indicate the device.

Scheduling

I’ve found that it’s often best to perform the clinical trial cases either first or last on a surgical schedule to avoid disruptions of the clinic’s usual flow. It is also important not to do too many clinical trial cases on a single day because this can also throw a wrench into the flow and become overwhelming for the staff due to the increased level of stress and additional or different protocols that come with a clinical trial case.

Bringing the research coordinator to the operating room is critical for success. This person can connect as a resource and serve as an additional set of eyes and ears to help the ASC team execute the clinical trial case smoothly.

Staff Resistance

One of the biggest challenges that surgeons face when integrating new technology into the operating room, whether it is in a clinical trial or already FDA-approved, is resistance from staff. They are usually already overburdened, so taking on additional responsibility or learning a new machine or protocol can seem like the last thing they need.

It is very helpful to have a meeting with the surgical team and explain why the new technology or clinical trial is being performed and how it will benefit patients. If it is communicated that this is something that will ultimately lead to better outcomes for the patient, I find it is much easier for the staff to get behind the process.

Lay the Groundwork, Find New Leaders

Oftentimes the heavy lifting takes place with the first clinical trial a surgery center undertakes. However, the procedures and protocols put into place can then be used for future trials. Identifying key staff members to help in the trials will also ease the process.

The ASC leadership as well as the surgeon should identify 1 or 2 people on staff who exhibit attention to detail, a passion for new technology, and a positive attitude toward learning new things, such as the clinical trial protocols. Beyond the clinical trial, this is a great opportunity to find a potential new leader in the ASC.

Meeting with the staff members independently and asking if they are interested in the role is usually the best way to handle this. Additional compensation can be offered if the position requires working after normal business hours.

Worth the Effort

Although it may seem daunting to undertake clinical trials in a busy surgery center, once the infrastructure is put in place it becomes more routine and sustainable. With proper planning and contract negotiation, incorporating clinical trials can create a win-win-win for the patient, the surgeon and the ASC. OASC

Robert J. Weinstock, MD, is director of Cataract and Refractive Services at the Eye Institute of West Florida and The Weinstock Laser Eye Center. He's also surgical director of the Largo Ambulatory Surgery Center and an associate clinical professor of Ophthalmology at the University of South Florida.