Let’s begin with a top-level view of the clinical trial landscape. What dynamics are you experiencing, and how do they weigh on whether your site chooses to participate in a study?
Cassandra Cone: Most studies currently are in early phases (ie, phases 1 and 2) exploring similar indications. Investigators are sometimes less interested in enrolling patients in these early phase studies, as they are shorter in duration. Still, there are many studies to choose from at the moment, so we can be selective about participation.
Yvonne Santiago: Sites that have struggled with staffing may find that phase 1 studies are easier to complete. Such studies are open label, as opposed to larger studies which require masked and unmasked teams. In that sense, phase 1 studies allow sites to use their staff more flexibly.
Amy Ewald: Rather than study duration, the amount of work needed per patient is a driving determinant at my location. We prioritize efficiency. If a study requires steps outside of a typical study scope—say, complex bloodwork—we may be less likely to participate in that trial.
Staffing structures vary between clinics. How do you go about staffing, and do you have a team designated to research?
Diane Deininger: We have dedicated coordinators, and we share other technicians with clinic. Having no limit on how many personnel can be certified for a study maximizes flexibility. We generally like to hire experienced coordinators (as they typically have a medical background) and train them in retina. So, it’s a little easier to train on that end. I find that hiring from within the clinic can be challenging, as there are differences between research-based and clinical mindsets.
Ms. Cone: Our leadership team determined a long time ago that they wanted a team completely devoted to clinical trials. And if slower periods leave staff underutilized, they are temporarily assigned other projects (ie, laboratory inventory, pulling documents to prepare for future projects) until clinical trial work ramps up. We’ve started to clearly define responsibilities (ie, number and types of studies) based on seniority. This helps with retaining staff, as people can see a path for career advancement.
Ms. Santiago: I was the clinic manager when our site first started with clinical trials, at which point I was also tasked with being the study coordinator. At first, I was able to wear both hats effectively. As we grew research, it became clear that we would need designated leadership for each individual department, and we hired a clinic manager so that I could move full-time to study management.
We have dedicated photographers but share BCVA technicians with clinic. To ensure coverage, we provide study schedules with the clinic manager a couple of weeks in advance so that person can allocate staff. The practice understands that clinical trials are a vital part of the practice, and they have to make accommodations.
Communication between study sites and CROs is foundational to running a smooth study. Which elements of this relationship could be improved?
Ms. Santiago: During startup, I field requests from multiple CRO staffers. Many times, different people ask for the same documentation, which makes me think they’re not communicating on their end. Having to resend documents I already sent makes the early stages of initiating a trial inefficient.
Ms. Deininger: Similarly, documentation requested during the feasibility phase is often re-requested by CROs after a site is selected. If they checked internally before reaching out to us, they might find that some of their requested items are already in their possession. This redundancy drains us.
Ms. Cone: We continue to work with the same sponsors and CROs on multiple studies, and we have to continuously redo the same work over and over just because a different project team has been assigned to a new study. Communication within the organization to capitalize on prior work can make start-up efficient.
Ms. Ewald: I don’t think documents are always being placed in central files as indicated. For example, when there is a new monitor, we may be asked to provide the same documents because the last monitor’s email doesn’t work, and they didn’t upload it to the central file. Centralized portals where sites, CROs, and sponsors could store documents were clever in theory but flawed in practice. I keep local versions of all files so I can easily send them when they are inevitably re-requested.
Much of a site’s success depends on enrolling patients. What strategies do you use to meet that enrollment estimate?
Ms. Ewald: For every new trial, the PI will send out an email to other physicians highlighting specifics. And during the course of the trial, the PI provides consistent reminders both via email and via our clinics’ weekly meetings, which helps tremendously. If our unmasked study coordinator or research assistants are available, they, too, will help with recruitment.
Ms. Deininger: Our practice has multiple satellite offices, and we keep physicians who are not PIs abreast of enrollment criteria for studies that a PI has undertaken. Every Monday, we send out information on the enrolling studies so they are constantly reminded. If a practitioner at a satellite office encounters a patient who may be a good fit for a study, they alert our central office so that our research staff can connect with the patient to gauge interest and eligibility.
Ms. Cone: We have dedicated research referral coordinators who handle recruitment among all our physicians. Retinal physicians are a competitive bunch. During the weekly clinician meeting, in addition to trials updates, our team shares how many patients each physician in a practice has enrolled. If one doctor has recruited 10 patients and another has recruited zero, you tend to find that the doctor at the bottom of the list has a renewed focus on enrollment.
Before we wrap up, we need to talk about the heart and soul of clinical trials: patients. What tips would you give other study coordinators who face challenges with patients following protocols?
Ms. Santiago: Patients are compassionate people, and appealing to their sense of altruism can help them understand the importance of a clinical trial. When they frame trial participation as a way of giving back to the world, then they feel like they are contributing to the greater good.
Ms. Deininger: If patients are treated with concierge-like services, they’ll show up. Transportation services in particular have been useful. Although some patients ask for stipends, most study patients have no financial motivation.
Ms. Cone: Just as we study coordinators wish for a single point of contact at a CRO, patients want to have a staff member they can directly reach with questions or concerns. They want a personal relationship underpinning their role in the study. If we can provide that, then we know we’re treating our patients right.
