David A. Eichenbaum, MD, FASRS is director of research at Retina Vitreous Associates of Florida and collaborative associate professor at Morsani College of Medicine, University of South Florida, in Tampa, Florida. He has been a clinical trial investigator for the past 16 years, participating in more than 90 trials studying common retinal diseases such as dry and wet age-related macular degeneration, diabetic eye disease, and retinal vascular disease. Dr. Eichenbaum is a Fellow of the American Society of Retina Specialists and the American Academy of Ophthalmology, is immediate past president and sits on the board of the Florida Society of Ophthalmology, and is past president of the Tampa Bay Ophthalmic Society. During our conversation, which has been edited for length and clarity, Dr. Eichenbaum discussed his experiences as a clinical trial investigator and provided advice for younger retina specialists on how to become involved with trials.

Retinal Physician (RP): What inspired you to become a clinical trial investigator, and how did you get started?

Dr. Eichenbaum: I was inspired by my work as a fellow with my mentors. Jeff Heier, Elias Reichel, Jay Duker, and Caroline Baumal were particularly impactful. I realized that the combination of clinical retinal care and development and scientific progress in a combined retina clinic/clinical trial setting could be a fantastic way to contribute to helping patients on “main street” and more broadly. 

My first clinical trial was an investigator-initiated trial (IIT) that evaluated dosing of Lucentis (ranibizumab) in diabetic macular edema (before it was FDA-approved for this indication!) with a grant from Genentech in 2008.

RP: Can you walk us through the process of setting up a clinical trial in a retinal practice, from obtaining funding to patient recruitment?

Dr. Eichenbaum: The best way to start is either with an IIT or by joining the DRCR.net program. I served as my own coordinator for my first trial and that was very capital-
efficient. It was a wonderful learning experience and took a lot of time. I was brand new in my career, so I had the time then! I learned all about protocol development, filing an investigational new drug (IND) application, regulatory documentation, budgeting ... essentially all the bones of clinical trial work.

Investigator-initiated trials provide grants to the investigator and that funding can also be used to hire a coordinator to help. An experienced clinical trial coordinator is incredibly valuable to a new investigator. I would recommend no more than 1 staff member for a first clinical trial, and sometimes an existing staff member can contribute time to this, and that time can be funded by the IIT grant or DRCR.net budget.

RP: What are some best practices for setting up the physical location of a trial site?

Dr. Eichenbaum: We integrated our first site into our existing clinic, making 1 lane a certified visual acuity lane and 1 machine a certified device for each required protocol imaging assessment. Starting out, subject volume is low, and I think this is the best way to begin.

RP: What are some of the biggest challenges you’ve faced as a clinical trial investigator, and how have you overcome them?

Dr. Eichenbaum: The biggest challenge we had after we started growing was space and staffing. We made gradual changes to our footprint and gradually increased staffing as we added clinical trials and subjects. We made a bigger commitment 2 years ago when we opened a dedicated clinical trial building connected to one of our clinics. 

Another challenge was integrating clinical trials into the culture of the practice, because our group had no clinical trial experience from the time of the Collaborative Ocular Melanoma Study (COMS; 1986-2003) until I started the modern program in 2008. The culture changed gradually as more doctors from our group became involved in the operations and excited about the science of the clinical trials, and we hired new doctors who were eager to grow the program.

RP: How do you ensure patient safety and adherence to protocols during a clinical trial?

Dr. Eichenbaum: We have 2 fantastic, committed, experienced clinical trial managers who have been with our site for a decade or more. Our clinical research manager is patient facing and works with me, our CEO, and our clinical trial coordination staff to optimize our operations. Our quality assurance and contacts manager works specifically on QA/QC, budgets, and invoicing, and she and I communicate nearly daily and continually improve our processes. We have a stable staff of coordinators and assistants who enjoy the work and are valued for their contribution to the program. It is absolutely true that a site lives or dies by its staff, and I try to ensure my team is appreciated and supported.

RP: What advice would you give to retina specialists who are interested in becoming clinical trial investigators but are unsure of where to begin?

Dr. Eichenbaum: There are 3 keys to getting started. First, have a good attitude and be easy and fun to work with. Second, go to meetings (AAO, ASRS, ARVO every year, for starters), as this will provide opportunities to meet the sponsors. Third, say “Yes” to opportunities, then do what you say you’re going to do.

The sponsors want to develop new sites. All a new investigator needs to do is be responsive and reliable. In 1977, Woody Allen said, “80% of success is just showing up,” and he’s right. It’s easy to get started; try my 3 tips and just show up. You will succeed! RP