Our field is in the midst of a Cambrian explosion. The breakneck evolution of surgical and medical retinal technology over the past decade has advanced our ability to treat patients who, in an earlier era, might have otherwise gone blind. Traditional academic bench and translational research has no doubt played a pivotal role in this explosion. However, without the infrastructure and backing of the surgical instrument and pharmaceutical industry to bring innovations to the marketplace, this evolution may have been stunted.

Symbiosis between retina physicians and industry has undoubtedly been important in advancing patient care, but the influence that industry can have over physicians cannot be ignored, especially in a health care system with finite resources. How do new graduates get involved with consulting, enrolling in clinical trials, and advocating for a product they believe in while maintaining good ethics?

We asked Charles C. Wykoff, MD, PhD, and Jason Hsu, MD, to provide insights into some of the nuances of physician-industry relationships.

After fellowship, what was your path to collaborating with the pharmaceutical or surgical industry? Was it something you actively sought out, or did it occur organically?

Charles C. Wykoff, MD, PhD: I started practice with a firm background in both laboratory-based basic science and retrospective clinical series and was actively interested in transitioning into clinical trials. I joined a group that would let me make that transition a priority. Since then, my interaction with the science side of industry has been incredibly insightful and productive. From preclinical drug and device development, to moonshot phase 1 trials, to the rigors of phase 3 trials, to post-hoc analyses of completed datasets, there is so much going on in the retina space, and there are a tremendous number of avenues to pursue. I initially became familiar with industry collaborations through writing investigator-initiated trials. Although these are a lot of work, they can be a great way to pursue pilot studies focusing on clinically relevant topics.

Jason Hsu, MD: I have had a strong interest in clinical research since residency. There is a certain unique high that comes with discovering a new association or possible intervention that might help patients. In many ways, my desire to further our field was shaped by one of my mentors, Stuart L. Fine, MD, who always touted the importance of well-designed randomized clinical trials. After my fellowship, I joined an academic private practice that was already involved in many industry-sponsored clinical trials. Being a site principal investigator for various studies helped open up opportunities for industry collaboration. However, since my clinical research interests have generally not relied on industry sponsorship, I have not actively sought out such collaborations. Companies have found me based on hearing about the research that I was working on.

Dr. Wykoff has specific advice for any young retina doctor looking to actively collaborate with industry.

“If you want to take it further, join or start a collaborative effort,” he said. “Our field is small and teeming with exceptionally insightful and hard-working colleagues.”

He sees three broad avenues for physicians to readily pursue prospective clinical research:

  • Collaborative non–industry-directed trials. For example, the Diabetic Retinopathy Clinical Research Network (DRCR.net) is a successful, enduring collaboration of academically oriented practitioners across North America committed to studying diabetic retinopathy and its many manifestations. DRCR.net provides an excellent forum to learn the intricacies of clinical trials from start to finish. Check out drcrnet.jaeb.org and consider becoming an investigator.
  • Industry-initiated trials. Collaboration with industry is essential to the process of bringing new pharmaceuticals and devices to market for the benefit of patients. To get involved in this space, get to know your local medical science liaisons, also known as MSLs.
  • Investigator-initiated trials. Many pharmaceutical and device companies are interested in ideas about how their products could be used in innovative ways and will consider sponsoring a well-designed study addressing an unmet need.

In your view, what are the issues surrounding physicians collaborating with or consulting for industry?

Dr. Wykoff: Being intimately involved with research requires significant investments of time, focus, and resources.  Early in my training, Steve Charles, MD, summarized this concept well for me, and I paraphrase him: To be good at research or innovation, you need to be willing to give it your all. I have found his words to be in line with my experiences.

It is gratifying to develop a trial, enroll patients, complete the trial, and present and publish the findings. But each step takes far longer than one might anticipate or expect from an outside perspective. There are a tremendous number of spots where progress can stall or completely break down. As an example, as a primary investigator one has substantial control of what data are collected and how it is analyzed, but much of the data collection itself is performed by team members, including research coordinators, fellows, and certified photographers. These personnel and their oversight are essential to the success of a prospective research protocol.

In all that we do clinically, whether through a collaboration with industry or not, it is imperative to keep patients’ best interests always in center focus. For example, consider closely the control arm of a potential clinical trial. In a field with excellent treatment options for many diseases, one must consider all possible scenarios for your patients.

Dr. Hsu: It is becoming more and more likely that innovation will probably come from the private rather than the public sector based on the decrease in government funding of research. As a result, I think industry collaboration will become an increasingly important component for improving patient care. My interest in collaborating as a consultant has been primarily to help design new studies and applications for a company’s product.

What is your perspective on recent research analyzing physician-industry interactions and anti-VEGF use?

Dr. Wykoff: It is interesting and deserves more study. Every physician should regularly assess what they do and why they do it. I try to treat patients as I would want to be treated, and I try to recommend medications for patients that I would like to use in my own eye for their given situation and disease state. Unfortunately, local and national economic and political factors often encourage or even mandate the use of medications that I would not choose as first line treatment for myself or my family. I am a believer in patient and physician choice, and I try to base my management decisions on good science and clinical trial data wherever possible.

Dr. Hsu: The recent research regarding the influence of physician-industry interactions and anti-VEGF use is not surprising. These types of interactions have been well-documented throughout medicine as influencing prescribing patterns. I believe this is one of the major potential pitfalls that any physician must remain aware of, regardless of his or her level of involvement with industry. My approach to patients is always to ask myself, if I or my family were in this situation, what would I want done? When one approaches medicine in this manner, the risk of being led astray may be lower.

What advice would you give to graduating fellows looking to participate in clinical trials or to become a key opinion leader?

Dr. Wykoff: If you have a desire to be involved, jump in! There are a multitude of opportunities, from the basic sciences to all stages of clinical research to device design. Look for new perspectives.

If you have limited experience with research, read the journals and start small. Read what you find interesting. Browse the abstracts of our major journals. Subscribe to their email updates, and browse the titles to identify papers that interest you. Let your clinical experiences stimulate questions. Present an interesting case or case series at local or regional meetings, and consider publishing the work.

Dr. Hsu: It is important to have an understanding of ongoing studies. If you are joining a group that is already participating in clinical trials, get involved early. Ask the senior partners to consider allowing you to be the site principal investigator, especially for studies that you strongly believe in based on the science. If your group would be new to clinical trials, I suggest reaching out to various industry sponsors and letting them know you are interested in being a site for current or future studies. If you have an interesting idea for a novel application of an existing drug or a post-hoc analysis of an existing clinical trial, consider reaching out to the relevant medical science liaison and pitching the idea. This may lead to investigator-initiated trials, publications, podium time, and greater recognition.  n

 

Section Editor Murtaza Adam, MD
• second-year retina fellow at Wills Eye Hospital in Philadelphia, Pa.
• madam@midatlanticretina.com

Section Editor David Ehmann, MD
• second-year retina fellow at Wills Eye Hospital in Philadelphia, Pa.
• dehmann@midatlanticretina.com

Section Editor Sundeep Kasi, MD
• second-year retina fellow at Wills Eye Hospital in Philadelphia, Pa.
• skasi@midatlanticretina.com

Jason Hsu, MD
• co-director of retina research and faculty member of the retina
service of Wills Eye Hospital; managing partner, Mid Atlantic
Retina; and assistant professor of ophthalmology, Thomas Jefferson
University, all in Philadelphia, Pa
• financial disclosure: consultant for UCB, speaker for Roche/
Genentech, Ophthotech, and Santen
• jhsu@midatlanticretina.com

Charles C. Wykoff, MD, PhD
• co-director of research at Retina Consultants of Houston; deputy
chair of ophthalmology, Blanton Eye Institute, Houston Methodist
Hospital, both in Houston, Texas
• financial disclosure: consultant for Alimera Sciences, Allergan,
Alnylam, Bayer, Clearside Biomedical, DORC, Genentech, ONL
Therapeutics, Regeneron Pharmaceuticals, ThromboGenics, and
Valeant; speaker for Allergan, Apellis Pharmaceuticals, Clearside
Biomedical, DRCR Network, Genentech, Iconic Therapeutics,
Ophthotech, Regeneron, ThromboGenics; lecturer for Allergan
and Regeneron Pharmaceuticals
• @TxRetinaSurgeon; CharlesWykoff@gmail.com