Designing a Clinic and a Research Center Side By Side

A look at the symbiotic relationship between the Retina Research Center in Austin, Texas, and the private practice next door.

By Ivana Gunderson, BS; Boris Corak, JD; and Brian B. Berger, MD
 

Retina Research Center (RRC) was established in 1999 to perform clinical trials for retinal diseases. RRC is a freestanding facility located in central Austin that specializes in research for treatment of retinal diseases such as age-related macular degeneration (AMD), diabetic retinopathy, retinal vein occlusions, and uveitis. In addition to evaluating novel drug therapies, RRC conducts clinical trials that may potentially lead to improved surgical procedures and drug delivery devices. At the RRC, we strive to ensure that every patient is an optimal fit for a particular clinical trial and is afforded unique, individualized care.

Because RRC is located next to the clinical practice of Brian B. Berger, MD; Chirag Jhaveri, MD; and Saradha Chexal, MD, patients can receive either the latest treatments approved by the US Food and Drug Administration (FDA) or alternative treatments being evaluated in studies at RRC. The latter option is especially advantageous for patients diagnosed with a disease for which there is no FDA-approved drug, such as dry AMD, for which the current standard of care is multivitamin supplements.

RRC participates in clinical trials in phases 1 through 4 that are funded by universities, the National Institutes of Health, and private industry. Most study participants are recruited from the clinic, and research coordinators work with the clinic’s staff to seamlessly transition patients between the clinic and RRC. Clinic patients are informed about enrolling clinical trials through study posters, PowerPoint presentations played in the examination rooms, and recorded messages play through overhead speakers. The clinic’s staff is provided with a variety of tools, including customized study summary binders and general or study-specific research brochures, to keep both the staff and patients informed of trials open to enrollment.

In addition to enrolling patients from the clinic, our doctors work with area ophthalmologists who refer patients to RRC for particular trials. This is beneficial to both physicians and patients: Referring ophthalmologists can continue to care for their patients’ needs while participating as subinvestigators at the RRC, and patients have the comfort of knowing that they will still see their original ophthalmologist for nonretinal needs.

THE FACILITIES AT RRC

The facilities and equipment in the RRC are specifically designed for clinical trials. The RRC is a self-contained suite with a separate entrance from our clinic. It has 2 designated examination rooms, 2 separate ETDRS vision lanes complete with trial lens sets, an allocated electrocardiography room for patient privacy, a laboratory specimen processing room, a Summit AccuCold pharmaceutical refrigerator, a specified phlebotomy room, a secured conference room for monitors, and a designated photography area. Our photography area is equipped with multiple optical coherence tomography machines, 2 retinal cameras for fundus photography and fluorescein angiography, and a microperimeter. The examination rooms are fitted with computers, allowing physicians to provide patients with detailed and easy-to-understand explanations of digital test results (Figure 1).

Because the length of the office visit in a clinical trial is frequently longer than a clinic visit, we try to provide a comfortable environment. We provide free Wi-Fi service, 2 spacious waiting rooms with reclining couches, 2 flat-screen televisions, coffee, snacks, blankets, and a private restroom (Figure 2). We also provide a conference room that allows patients to work remotely during long visits (Figure 3). We try to create a sense of community among research patients, and, as a result, many patients have participated in multiple trials. We keep patients informed of trial openings via a newsletter containing information about upcoming trials, updates on ongoing trials, and results of completed trials.

THE TYPICAL PATIENT VISIT

From the moment a patient checks into RRC, he or she notices a distinct difference in our approach to patient care. Upon arrival, the patient is not required to sign in or complete any new patient paperwork; instead, patients are greeted at their appointment time by the coordinator scheduled to conduct the visit. The research schedule is purposefully lighter compared with the clinic schedule, which allows patients adequate time with the coordinator and doctor and minimizes time spent in the waiting room. Also, because RRC works strictly with patients enrolled in clinical trials who are scheduled for specific visits, research patients are not interrupted by emergencies and other disruptions common in a high-volume clinic.

On a patient’s first visit, he or she is promptly taken to a private conference room and given as much quiet time as needed to review the informed consent; if this is a follow-up visit, the patient is directed to a vision lane. Next, the patient is ushered to an examination room that is designated for that individual’s use during his or her scheduled time in our office so the coordinator and patient have ample time and privacy to review medical history, changes in medications, and adverse events; to obtain vital signs; and to complete any other study assessments. Most study visits require an eye examination and some type of imaging, both of which require dilation. While the patient’s eye dilates, he or she may either wait in the designated examination room or in 1 of 2 private waiting rooms where television, snacks, and coffee are available (Figure 4).

After imaging, the patient sees the doctor for an examination and/or treatment and to complete any posttreatment assessments. At the conclusion of the visit, a coordinator will schedule the patient for a return appointment and arrange transportation home.

SECURITY AND SAFETY

Patient privacy and data security are crucial to drug research and are high priorities of the pharmaceutical industry. Every room in RRC can be locked, ensuring that only authorized users can enter a given space. Monitor visits take place in designated conference rooms that are prepped by the study coordinator to ensure that only documents pertaining to that particular study are available for the monitor to review. In addition to the research conference room, the adjoining retina clinic has a separate conference room allowing us to simultaneously accommodate 2 study monitors in separate spaces. Having a separate business office with a copier, scanner, and fax machine ensures that monitors have no need to venture into our clinic office.

The separate identity of RRC ensures that only people affiliated with a particular study are allowed into the building. All nonpatient visitors, such as monitors, are required to schedule an appointment before arrival. Upon arrival, visitors must sign in and are allowed to enter only if accompanied by a staff member. In order to ensure the full integrity of our studies, pharmaceutical sales representatives are prohibited from entering RRC. The vast majority of drugs used in RRC are provided by study sponsors, meaning that medical insurance and pharmaceutical representatives have no role at RRC. Our clinic, however, is a retina practice that treats patients for various retinal diseases with FDA-approved therapies. In our clinic, pharmaceutical sales and insurance representatives may schedule appointments to consult with our physicians and staff regarding newly approved drugs and coverage discussions.

MAINTAINING CERTIFICATION

A vendor chosen by the study sponsor certifies all medical equipment and RRC staff. Our photographers are certified by 8 major reading centers worldwide. The photographer certification includes capturing protocol-specific retinal images and submitting them for evaluation by the chosen reading center. Our visual acuity lanes and examiners and ETDRS lanes are continually certified by EMMES, Touchstone, CertifEYED, and Clinical Edge. The coordinators continually train on site and maintain current Human Subjects and Good Clinical Practices certificates through Collaborative Institutional Training Initiative or through sponsor training. In addition to on-site training, our doctors and coordinators attend sponsor-funded investigator meetings prior to trial initiation. The purpose of these meetings is to educate the study staff on the protocol, drug mechanism, trial objectives and FDA regulations.

MEETINGS AND FUNDING

For our staff, attending retina meetings is the most efficient way to learn about the future of drug development and establish relationships with key innovators to bring new clinical trials to Austin. Retina research from around the world is presented at the annual meeting of the Association for Research in Vision and Ophthalmology. At these meetings, our doctors and staff often present study results from trials in which we have participated. Presentation posters from these meetings serve as educational art in our research office to inform our patients, visitors, and students of study outcomes (Figure 5). Meeting attendance is crucial, because it allows our staff to stay up to date on new treatments and develop relationships with other scientists. Having a separate facility and staff for research allows us to calculate our costs for doing a study. This knowledge is used to prepare and negotiate budgets for clinical trials and gives us a clear financial picture regarding the profit from each study.

The expenses associated with educational meetings can be partially offset by funding from The Institute for Retina Research, a 501(c)(3) nonprofit foundation established by the doctors. In addition to offsetting meeting costs, tax-deductible donations to The Institute for Retina Research allow us to participate in unfunded trials, conduct independent research, and improve and diversify our educational offerings to students. Many of the donations come from grateful research patients.

EDUCATIONAL OPPORTUNITIES

Teaching and education are important parts of RRC. Drs. Jhaveri, Chexal, and Berger are directly involved with the Texas A&M College of Medicine, University of Texas Medical Branch at Galveston, and the Health Careers Mentorship Program at the University of Texas at Austin. Our physicians devote their time to train and educate current and future medical students in the latest advances in the field of ophthalmology. By its nature, performing research involves discussion and understanding of the pathophysiology of diseases and new ways to alter disease processes. With every new trial, there is a discussion during the site initiation visit of the basic science regarding the mechanism of action of the investigational product and how it compares with current treatments. All of the research to date regarding the drug is detailed in the investigator’s brochure.

Site initiation visits are educational opportunities for medical students and others pursuing health science careers. The basic science discussions are repeated at recruitment dinners, which are open to students. Student participation in RRC activities provides a unique opportunity to see how drugs are developed and medicine advances. The educational environment that we have created in our office has inspired many RRC volunteers and staff members to further their careers in medicine. These are some of the contributing factors that led to Dr. Berger receiving the University of Texas Medical Branch at Galveston Top Doc teaching award in 2013.

A PARTNERSHIP FOR SUCCESS

Despite being located next to each other, RRC and the clinic of Drs. Berger, Jhaveri, and Chexal each serve unique functions. RRC primarily focuses on evaluating novel drug therapies in clinical trials with the purpose of bringing them to market. Optimum patient care is the shared goal between RRC and the clinic. We know that patient volunteers are vital to the success of our studies; therefore, we pride ourselves in creating a comfortable environment, which results in high enrollment and retention rates. n

Ivana Gunderson, BS, is the clinical research coordinator at Retina Research Center in Austin. Ms. Gunderson may be reached at igunderson@e-retina.net.

Boris Corak, JD, is a technician at the practice of Brian B. Berger, MD, PA, in Austin. Mr. Corak may be reached at bcorak@e-retina.net.

Brian B. Berger, MD, is the president and owner of Retina Research Center and owner of the practice Brian B. Berger, MD, PA, both in Austin, Texas. Dr. Berger may be reached at bberger@e-retina.net.

 

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About New Retina MD

New Retina MD delivers cutting-edge content to retina specialists in their first 15 years of practice. Each issue provides fresh insight from younger physicians plus established mentors on clinical and nonclinical issues affecting ophthalmologists in the earlier stages of their careers. NRMD features surgical pearls, clinical research endeavors, practice management, medical reimbursement and policy, continuing educational requirements, financial planning, innovations, and more.