Bringing Trials to the Clinic: A Guide to Clinical Research in Oculoplastics
Author: Steven Leibowitz
Base Hospital / Institution: UCLA
Rapid fire oral presentation
Abstract ID: 25-375
Purpose
Clinical trials are foundational to the advancement of evidence-based medicine, particularly within oculoplastic surgery – a dynamic subspecialty where innovations in both functional and aesthetic care demand rigorous scientific validation. High-quality trials not only generate data for new therapies but also serve as the basis for standardized treatment protocols. With thyroid eye disease, the impact of clinical research has been transformative. The approval of Teprotumumab was driven by randomized clinical trials that redefined the landscape for thyroid eye disease. Many patients, especially those with limited or suboptimal management options, are eager to participate in research that offers hope for better outcomes. As surgeons, engagement in clinical research enables us to shape the future of the field, contribute to translational medicine, and solidify the highest standards of patient-centered care. Developing, initiating, and managing clinical trials is a skillset that should be accessible.
Methods
We review the process of organizing and participating in a clinical trial to improve physician fluency and understand of the principles of study design, regulation, and compliance.
Results
Clinical trials offer an alternative to standard treatment and potential for superior therapeutic outcomes. Initiating a trial requires collaboration and coordination of a multidisciplinary team. A site management organization would include a clinical research coordinator, compliance officer, pharmacist, physician assistants, and the principal investigator. Effective and consistent communication with the trial sponsor is essential, especially during the beginning of the study. This involves navigating complex regulatory documentation and compliance contracts, which can be challenging. Thorough planning and constant communication are crucial to ensure regulatory compliance and trial success.
Conclusion
Clinical trials are highly regulated and can be daunting to physicians unfamiliar with its infrastructure. With appropriate guidance and support, the process is both manageable and rewarding.
Additional Authors
| First name | Last name | Base Hospital / Institution |
|---|---|---|
| Angela | Oh | UCLA |
| Robert | Goldberg | UCLA |
