Addressing Ophthalmology Clinical Trials Through Statistical Data Design

Discover a groundbreaking webinar delving into the statistical data strategies and considerations of ophthalmology clinical trials, as well as the development of new endpoints for rare and slowly progressing ophthalmic conditions. The choice of design for ophthalmology clinical trials requires careful consideration of the nature of the ophthalmic disease, the severity of the disease in each eye and the treatment being investigated. Trial designs that maximize data from each consideration are ideal. It is also critical to develop appropriate efficacy endpoints, even during the early phases of a drug development program. The exciting advancements in imaging and testing modalities in the field of ophthalmology have rendered them promising markers of disease progression.

In the analysis of ophthalmic data, restriction of analysis to data from one eye when data from both eyes are available will result in the wastage of useful data and potentially reduce power. If data from both eyes of some or all participants are used in the analysis, intra-eye correlation must be accounted for to avoid inflation of Type I error rate.

Further, a longitudinal follow-up that allows for the natural progression of a disease and the effect of intervention over time to be studied is gaining popularity in ophthalmic clinical trials. Longitudinal ophthalmic designs of studies using data from both eyes require the use of analyses that account for the correlation between repeated measurements in addition to the intra-eye correlation.

As a result, it is imperative to rely on robust statistical methods provided by experienced statisticians, as they play a crucial role in effectively addressing these challenges and supporting the design and analysis of ophthalmology clinical trials.

In this webinar, attendees will gain insights on:

• Ophthalmology trial design considerations and strategies
• The role statisticians play in the development and validation of ophthalmic endpoints
• The ongoing need for innovative and validated endpoints for rare ophthalmic diseases

Join this webinar to gain insights into ophthalmology clinical trials’ statistical data strategies and the role of statisticians in developing and validating ophthalmic endpoints.

Speakers

Maria Abraham, Sr. Manager, Biotatistician, Emmes

Maria Abraham, Senior Manager in the Biostatistics Department at Emmes, brings experience in leading statistical activities for clinical trials from protocol development to generating final statistical reports. Maria is also experienced in coordinating activities for and reporting to data and safety monitoring committees (DSMCs) and other committees in multiple therapeutic areas.

She has served on the data and safety monitoring committee, where her expertise as a statistician for a Phase II clinical trial in the UK evaluating a nebulized surfactant for severe COVID-19 has been invaluable. Currently, Maria plays a vital role in leading a ground-breaking ophthalmic project consisting of 20+ protocols, executing contracts and ensuring optimal staffing for high-quality results within specified timelines and budget constraints.

Prior to this, Maria served as a Biostatistician and later as a Biostatistician Manager, demonstrating exceptional skills and commitment to excellence.

Message Presenter

Supriya Menezes, Associate VP, Ophthalmology Center at Emmes

Supriya Menezes, MS, Associate VP of the Ophthalmology Center at Emmes, brings over 15 years of experience serving as a corporate leader and the Principal Investigator for the NEIS portfolio covering 40+ trials. Supriya has extensive experience in biostatistics, supporting data and safety monitoring board, and ophthalmology gene and cell therapy research.

She is an ex-officio member of the NEI Intramural Clinical Research Review Committee and serves on the NEI’s extramural grant review committees as a Statistical Reviewer. Additionally, she serves as the Reporting and Coordination Statistical Lead to three NEI Data and Safety Monitoring Committees (DSMCs) overseeing various NEI intramural protocols. She leads and collaborates with DSMC chairs and study investigators at the NEI and international sites to ensure high-quality statistical and logistical support for each DSMC.

Previously, she served as a Principal Biostatistician, providing statistical support for Phase II/III clinical trials and obtaining two patents for her work on an online statistical quality control system using S-plus to reduce sample preparation variability.

Message Presenter