At the Women in Ophthalmology (WIO) Summer Symposium held in Carlsbad, California, during August 2024, a team of experts discussed empowering women to excel in clinical research during a panel entitled, “Getting Involved in Clinical Research and Beyond.” The session was part of the WIO Clinical Trials Training program, which is intended to increase the number of women who are principal investigators and leaders in clinical research by providing them with the skills needed to succeed.

The 45-minute panel discussion was moderated by Lejla Vajzovic, MD, the director of the surgical vitreoretinal fellowship program at Duke University Eye Center in Durham, North Carolina, and Maja Kostic, MD, PhD, an assistant professor of clinical ophthalmology at the University of North Carolina in Chapel Hill. They led a productive and exciting discussion among panel speakers Michael F. Chiang, MD, director of the National Eye Institute; Majda Hadziahmetovic, MD, a retina specialist at Duke University Eye Center; Christine Kay, MD, of Vitreoretinal Associates in Gainesville, Florida; and Huma Qamar, MD, MPH, chief medical officer of Ocugen. Each of the panelists described their career paths and provided insights into key principles that helped enable their productive involvement in clinical research.

Dr. Chiang, a pediatric ophthalmologist, was asked to discuss gender-related inequities in grant support involving Research Project (R01) grants, the National Institute of Health’s most popular funding source for independent research projects. He noted that male ophthalmologists submit approximately twice as many grant applications as female doctors do. Once submitted, however, the grant application “success rate” is relatively equal, he said. Similarly, when it comes to industry-sponsored clinical trials in ophthalmology, there are more male principal investigators than female.

Describing background in research and academics, Dr. Chiang used anecdotes to explain his path into clinical research. He encouraged members of the audience to take initiative and seize research opportunities when they arise. He ended by stressing 2 key lessons: “Say yes [when asked to participate in trials] and do a good job — that will lead to more opportunities!”

Clinical Research in a Private Practice Setting

A different path in clinical research was described by Dr. Kay, a vitreoretinal surgeon and inherited retinal disease (IRD) specialist. Although she began her career on an academic clinical scientist track, receiving external funding for her research with a Career Development Award from the Foundation Fighting Blindness, after a few years in academia she moved into a private practice, becoming a shareholder and director of research at Vitreoretinal Associates. Dr. Kay described her current work in clinical research as “rewarding,” with opportunities to recruit highly capable clinical coordinators, work with supportive physician partners, and integrate philanthropic contributions for equipment.

“Finding a niche can be an effective way to become involved in clinical research,” explained Dr. Kay, who said that her clinical patient population and IRD database enables her to be highly recruited as a principal investigator (PI). Her surgical interest in subretinal delivery of gene therapy, as well as her initiative in making contracts with compounding pharmacies, positioned Vitreoretinal Associates as an attractive site for subretinal surgical trials, she said. Private practice settings often have the advantage of efficiency and autonomy in contract negotiations, as this can be done with less “red tape” than in large university settings. Dr. Kay emphasized the importance of pharmaceutical industry support to enable novel therapies to be developed for her IRD patients.

Overall, said Dr. Kay, her clinical research experience as a PI has been more productive in a private practice than it was in her first few years as an assistant professor in an academic setting. As a retina specialist, there are countless opportunities for becoming involved in clinical research, if one has the interest. Dr. Kay emphasized the importance in her own career path of attending and presenting at national conferences, building relationships with retina colleagues as well as industry representatives, taking the initiative to seize opportunities, and finding ways to solve problems in creative ways rather than be stopped by inevitable roadblocks along the way. Dr. Kay mentioned that her career path was certainly not a predictable straight line. She stressed the importance of being adaptable and flexible to learn and grow stronger through adversity.

Benefits and Challenges to Research in Academia

Dr. Hadziahmetovic, an associate professor of ophthalmology and electrical and computer engineering at Duke University, described how a postdoctoral fellowship at the University of Pennsylvania in Philadelphia shaped her approach to patient care and research. This experience cultivated her scientific curiosity, she said, driving her to understand the fundamental science behind clinical trial investigational products and the new medications she administers to her patients. Dr. Hadziahmetovic emphasized the importance of practicing evidence-based medicine and being selective about the collaborations and products she supports. She highlighted that patient welfare should always be the foremost concern for any clinician or researcher.

Reflecting on her early lab days, when ocular gene therapy was still in its experimental phases, Dr. Hadziahmetovic expressed amazement at the impressive advancements in gene therapy for retinal pathologies. She also shared her experience in academic research, underscoring the many benefits, such as the collaborative environment, mentorship opportunities, teaching, and access to resources. However, she acknowledged the challenges of working in academia, including the increasing difficulty of securing funding; balancing research, teaching, and clinical duties; and navigating institutional bureaucracy.

For those just starting in clinical trials, Dr. Hadziahmetovic advised that gaining experience in an academic setting is invaluable, particularly under the guidance of more experienced colleagues. She noted that many clinicians are not fully aware of the complexities, including regulatory issues, that are involved in conducting clinical trials, and recommended starting as a subinvestigator before taking on the role of principal investigator. She also encouraged building relationships with industry partners, submitting investigator-initiated studies to improve visibility, and not hesitating to ask questions or seek help when needed.

Perspective From an Industry Insider

Dr. Qamar provided the perspective from industry as the chief medical officer of Ocugen, a biotechnology company that investigates and develops gene and cell therapies for retinal diseases, including a novel gene agnostic AAV-mediated therapy for the treatment of retinitis pigmentosa. Her expertise includes the development of clinical trial protocols for studies in phases 1 through 4, US Food and Drug Administration (FDA) inspections, and effective leadership of medical affairs teams in the pursuit of novel therapies. Dr. Qamar described her experiences with regulatory agencies in the drug development process, stressing the importance of collaboration and forming relationships in clinical research.

Noting that many people use the expression “think outside the box,” Dr. Qamar believes that there is no box. Taking a visionary yet achiever approach and addressing patients’ unmet medical needs have been her prime focus, she said. “Your eyes cannot see what your mind does not know,” she said during the discussion to describe the need for researchers be aware of emerging trends in pharma/biotech and science. Networking, strategic planning, and looking at the emerging trends are key to advancing a career in clinical research, she said.

The panel concluded with a reminder to attendees to persevere and remain true to their passions, whether these lie in clinical research or in other pursuits.

Christine Kay, MD, is a vitreoretinal surgeon and director of research at Vitreoretinal Associates in Gainesville, Florida. She is involved as principal investigator in 24 clinical trials. She reports no relevant disclosures. Reach Dr. Kay at christinenkay@gmail.com.

Lisa M. Nijm, MD, JD, is a board-certified corneal, cataract and refractive surgeon at Warrenville EyeCare & LASIK in Warrenville, Illinois, and an assistant clinical professor of ophthalmology at the University of Illinois Eye and Ear Infirmary in Chicago. She is chief executive officer of Women in Ophthalmology. She reports no relevant disclosures.