There are multiple trials that an investigator can choose from. How do you decide on participation?
David R. Lally, MD: As a medium-sized retina clinic of five doctors in a single office, we are selective about studies. We aim to have only one study per disease state. We choose to have more in a disease state only if the studies are exploring different modalities of treatment (eg, intravitreal, oral).
Margaret Chang, MD, MS: For our newest trial locations, we are choosing studies that reflect the population that lives close by. In general, it is easier for us to enroll for phase 2/3 studies versus phase 1 studies. Our history with sponsors matters, too: if a sponsor has a good track record with us, we’re likely to participate.
David Eichenbaum, MD: I try to have two studies in common disease states enrolling simultaneously. That way, if one study stops enrollment, we are able to enroll patients in the other study. We’re likely to be attracted to a study with high enrollment goals and/or relatively few sites to justify the start-up costs required by our site to commit to the program. To ensure financial security in a practice that dedicates significant resources to clinical trials, we ask that sponsors agree to a fair market value budget in line with what we’ve negotiated for other trials.
Rishi P. Singh, MD: In an academic setting, trial participation accomplishes two goals: (1) offering a service to patients and (2) fulfilling the academic mission of the organization. We, too, try to enroll at least two studies in a disease state so that we have a back-up plan to offer if the first study folds. Studies with in-house PIs who have chaired past trials are also of interest to us.
How do you navigate enrollment? Sponsors, surely, remind you that they’d like you to prioritize their enrollment.
Dr. Chang: We do not overpromise on enrollment expectations. We allow the patients’ circumstances to guide enrollment. If they qualify for two studies but live closer to the practice location coordinating one of the studies, then we enroll them in that trial. It’s easy to overlook the potential of scribes and photographers as members of the recruitment team. We educate these staffers about enrollment criteria so that they, too, can identify potential study participants.
Dr. Eichenbaum: Dr. Chang is right: staff members are part of the recruitment team. We provide incentives for our study teams to review charts and find patients who may be good candidates for trials. Doctors within our practice are our best recruiters; patients trust their attending physician, and, if a site’s doctors believe in the scientific benefit of a clinical trial program, they are more likely to enroll their patients. Chart review services also help by applying filters that fit a study’s enrollment criteria—say, patients with extrafoveal geographic atrophy lesions and no history of neovascular age-related macular degeneration in the fellow eye—and quickly identify patients who are likely eligible for a particular trial.
Dr. Lally: All retina specialists at my practice must agree to sign onto a study before we commit. If we all agree that a study has merit and is good for our patients, then we know we’ll focus on enrolling.
Study staff is key to success at the site. How do you ensure that the team is supported and valued?
Dr. Lally: Coordinators are critical, and when PIs recognize their value, they will really flourish. Most of our coordinators started as technicians, and we transitioned some of our good technicians to be coordinators. Seeing how they find additional value to what they’re doing in their day-to-day work is really encouraging.
Dr. Eichenbaum: I built my team from the ground up, and the structure evolved as volume grew. I have an open door for my coordinators and ensure they are appreciated. Genuinely be thankful for their hard work, recognize them with appropriate rewards and bonuses, and offer them a workplace that is enjoyable and challenging. My team loves the opportunity to travel. All of the coordinators get to attend a major conference annually and investigator meetings. And we have team events to foster appreciation and collaboration.
Dr. Singh: From a CRO/sponsor’s perspective, personal engagement goes a long way and keeps the staff motivated. Keep constant communication on study updates, including hosting periodic on- and off-site meetings. I strongly encourage delegates to make time and effort to connect with the staff and make them feel like they’re a critical part of the team. Additionally, be responsive and available. It is frustrating for coordinators to wait sometimes 6 to 8 weeks to have documents reviewed.
Dr. Chang: Sponsors have started being a little bit more hands-on in terms of helping with logistics. For example, some offer pre-screening of charts and share best practices amongst study sites. Anything that can help study staff with the nitty gritty for their trials is helpful.
What advice would you give to fellowship graduates seeking to build a research portfolio?
Dr. Eichenbaum: Don’t underestimate the importance of building relationships. Talk with medical affairs representatives, attend all the meetings that you can, and deepen your interactions with senior mentors and practice partners. When you advocate for clinical trial participation at your practice, you’ll find that many senior partners are open to the idea when it comes from a young doctor who has demonstrated interest in furthering ophthalmology’s directive to improve patient outcomes.
Dr. Lally: Young investigators, after they demonstrate a genuine passion for study collaboration, should hone their understanding of study protocols. If you are easily accessible and know the nuances of enrollment criteria, you’ll be a resource to a practice that flags potential patients in the clinic. I’ve been on both sides of this, and I find that an investigator with a knack for remembering enrollment details can give me a real-time thumbs up or down on a potential study participant.
Dr. Chang: If you’re fortunate to find yourself in a practice with a clinical trial infrastructure, take advantage of the fact that that scaffolding is already built. Yes, you’ll need to put in a lot of time as a young investigator, but knowing that some of the foundational work is complete means that you can devote resources to enrollment and execution.
Dr. Singh: Don’t forget about colleagues from outside of your clinic. A lot can be learned from peer-level PIs and sub-Is generating trial momentum in their respective practices. When I first arrived at Cleveland Clinic, I sharpened my knowledge about how studies fit into the larger picture of ophthalmology by asking others how they found solutions to challenges similar to ones I faced.
