POSITIONING YOUR PRIVATE PRACTICE FOR CLINICAL RESEARCH

If you and your practice have a desire to contribute to advances in ophthalmology, research might be just up your alley. Many private practices find it rewarding to play a role in taking ophthalmic care and treatment into the future.

Vance Thompson Vision is a prime example.

“[Research] brings tomorrow’s technology to our community today, which is a pretty great gift we’re able to give to patients,” says Keeley Puls-Boever, COA, CCRC, research director at Vance Thompson Vision.

Ms. Puls-Boever should know. She helps lead Vance Thompson Vision’s research department, which has been involved in more than 150 device- and drug-related clinical trials during the past 33 years. Among them are clinical trials involving IOLs such as IC-8 Apthera (Bausch + Lomb), AcrySof IQ PanOptix and Vivity (Alcon), Tecnis Symfony and Synergy (J&J Vision), the Light Adjustable Lens (RxSight), as well as various other surgical and non-surgical studies such as corneal cross-linking.

“Our journey in research started through Dr. Thompson being one of the investigators in the original LASIK and PRK trials,” says Ms. Puls-Boever. Vance Thompson Vision employs more than 20 research team members who are currently running almost 50 clinical trials across five sites in the upper midwest and mountain west.

QUESTIONS TO ASK YOURSELF

Is research right for me?

Getting involved in ophthalmic research takes more than an altruistic attitude and a desire to make an impact that is bigger than you can make in your own practice. It also takes a clear-eyed look at your motivation, interests and willingness to dedicate the time, effort and resources to such an endeavor.

The first question to ask is why: Why do you want to get involved in research? What about it makes you want to get out of bed in the morning? There can be any number of reasons, but making a difference in the field should be toward the top, Ms. Puls-Boever says.

“If practices are getting involved with financial motivation as their driving factor, they may not be as successful as they hope. Being passionate and believing in the research you are participating in will make you far more successful,” she says.

Which path should I take?

The next question to ask is which path to pursue and where to concentrate your efforts. Do you want to focus on basic science or clinic trials? Maybe a little of both?

Basic science research takes place mostly at universities and institutions like the National Institutes of Health, but private practices can also be involved. Clinical research, on the other hand, consists of clinical trials where companies (and sometimes universities) partner with private practices to test and bring new lenses, devices and treatments to market. Choosing a specific specialty to focus on is also important.

“We’re currently an anterior segment surgical practice,” Ms. Puls-Boever says. “We usually do not get involved in drop studies unless they are a novel technology. We get involved more in studies that advance the field through surgery. We are passionate about first-of-their-kind, cutting-edge technologies,” including cornea, cataract, glaucoma, refractive and lid procedures.

LEARNING AND NETWORKING

Upon identifying an area of interest, the next step is to begin networking. Becoming a clinical trial site requires sharing your interest with colleagues and industry partners. Professional organizations such as ASCRS, ARVO, American Society of Retina Specialists and their Hawaiian Eye and Retina meetings, and the AAO and their conferences are ideal places to learn about research. For example, ASCRS hosted a YES Connect Webinar (http://bit.ly/3Z4EaNj ) in December moderated by Morgan Micheletti, MD, that discussed how private practices can get involved in clinical research.

“When we go to [the annual meeting of the] ASCRS, I take a team with me and we meet with about 20 industry partners while we’re there to discuss research,” says Ms. Puls-Boever, who has also hosted roundtable discussions at the meeting centered on research.

“It’s about relationships in ophthalmology and leaning into those relationships, whether it be with industry or other experienced ophthalmologists, and asking for guidance. Our practice is always open to helping new investigators and sites.”

BEING VETTED

Receiving an invitation to participate in that first study can take days to months. It is important for practices to maintain their lines of communication with their industry partners to help ensure their site is considered when the next trial starts. Ophthalmic drug and device makers typically begin vetting a prospective candidate for trial participation with a questionnaire and an on-site evaluation. As part of the process, they will also speak with the principal investigator and study coordinators and review the facility itself. (See “An industry perspective”).

“Usually you need a 4-meter lane. They’ll look at your space and make sure that it’s adequate, that you have a dedicated research team and that it’s not just your busy assistant that’s going to be helping you,” Ms. Puls-Boever says.

She also stresses the need for surgeons to be assisted by organized, self-reliant and motivated research coordinators. Conducting clinical trials takes more time for surgeons at the beginning as they and their team learn the study protocol and more about the drug or device and its expected use.

“But as a study moves through its life cycle, it should take less surgeon time, and this is where having a well-trained study team is key,” Ms. Puls-Boever says. “It takes a lot of time to do research, and if you as a surgeon have a good team/coordinators supporting you, then you will like research a lot more.”

SIGNING ON THE DOTTED LINE

Once selected to participate in a clinical trial, sites are provided with a contract spelling out the terms of participation, including study length, required number of patients and compensation. Clinical trials can involve fewer than a dozen to hundreds of patients and last from one day to more than 10 years. For example, Ms. Puls-Boever says, she helped conduct a study aimed at assessing the ability of the EyeGate Pharmaceuticals’ Ocular Bandage Gel to accelerate re-epithelization of the cornea immediately following LASIK. Participation was only one day.

“For the surgeon, that one visit did not involve much more time than performing a routine LASIK case,” she says, “but it did require an OD sub — to perform a slit lamp exam every hour. In the absence of an optometrist, a surgeon would perform the exam in such a study.”

That same study also required her, as coordinator, to spend time that day periodically surveying the patient on their pain levels and testing their vision. “Study coordinators also help to ensure all documentation is in place — data entry and completing logs that cover subject names, enrollments, stipends and any other required information,” she says.

Conducting clinical trials will take more time for surgeons at the beginning. During this time, the surgeon and their team will learn the protocol and more about the drug or device and expectations for use. As a study moves through its life cycle, it should take less surgeon time; this is where having a well trained study team is key.

TAKE THE OPPORTUNITY

While patients may be compensated for participation, clinic compensation remains “very much in line with reimbursement from insurance companies or cash-paying patients,” Ms. Puls-Boever says. Assuming the technology receives FDA marketing clearance, practices may benefit from participation through early access to the approved technology and ease of implementation due to experience gained during the study.

At the end of the day, though, Ms. Puls-Boever reiterates that participating in clinical research shouldn’t be about what ophthalmologists or their practice can gain from it. It should be about contributing to the greater good of the field and patient care.

“I would highly encourage people to approach it from the aspect that we’re given an opportunity to really make a difference,” she says. “If you do a good job, you’ll have a return on that initial investment, and it’ll all be worth it. OM

THE ACADEMIC PATHWAY FOR RESEARCH

Basic science research could be described as the headwaters of ophthalmology progress. It doesn’t involve human subjects. Instead, it focuses on experimentation involving cell lines, mice and other animals, and disciplines such as chemistry and physics. While basic science research takes place mostly in laboratories at universities and institutions such as the National Institutes of Health, practicing ophthalmologists can also participate, says Julie Schallhorn, MD, MS.

“I spend about 60% of my time seeing patients and 40% of my time doing research,” says Dr. Schallhorn, a cornea and refractive surgeon and associate director of University of California San Francisco’s residency program, where she organizes classroom and research curricula. “I kind of straddle that transitional role with some of my collaborators, advising them on any findings that they have in their lab or in animal models and then discussing how those could be translated into humans.”

PASSION AND A COLLABORATIVE SPIRIT

Dr. Schallhorn says people who thrive in the academic research setting are those who “love everything” about ophthalmology, but they also enjoying asking and exploring the answers to questions like, “Why is a specific disease process taking place, and what is the best way to treat it?”

Dr. Schallhorn is currently studying a small molecule nanomolar potency CFTR activator being developed by Vanda Pharmaceuticals as a novel treatment for dry eye. “The initial testing of that was looking at ocular surface potential difference measurements and looking at the transepithelial electric potential difference in mice,” she explains. “We actually developed that technique further and ended up patenting it in humans for cystic fibrosis. That’s the kind of cool stuff that happens at a university.”

In addition, Dr. Schallhorn says that people do well in this type of role if they have a collaborative spirit. “I love hearing what other people are thinking about and what other people are doing, and I wonder how that would work in this setting or that setting,” she says.

TIME COMMITMENT REQUIRED

Like clinical trials, basic science research requires a significant commitment of time, often measured in many years, even decades.

“Basic science is not something that happens overnight,” says Dr. Schallhorn says. “It’s really something that’s best done in an academic setting, so if you [are a resident and] really like lab stuff, think heavily about staying at a university and pursuing that pathway for research.”

With clinical research, money should not be the primary motivation for pursuing academic research, nor should either path be considered better or more noble than the other, Dr. Schallhorn says. They both contribute to the progress of ophthalmic care and treatment

“I think there’s a feeling in the community that research in the academic setting and research in private practice are at loggerheads and are immiscible, but people should view them as complementary to each other,” Dr. Schallhorn concludes. “We’ve got a really good ecosystem for research in this country, and advancements made in private practice and advancements made in the academic institution really result in rapid leaps and bounds forward for patient care.” OM