Addressing Ophthalmology Clinical Trial Design and Effective Data Monitoring Committee Strategies

Discover a groundbreaking webinar delving into the statistical data strategies and considerations of ophthalmology clinical trials, as well as supporting Data Monitoring Committees (DMC) charged with safety and efficacy reviews.

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. Therefore, 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.

Additionally, it is crucial to implement effective strategies for establishing DMCs and reporting to these committees in order to ensure successful execution. By creating well-crafted presentations that accurately represent ophthalmic assessments in a meaningful and concise manner, DMCs can provide valuable recommendations to Sponsors. Since ophthalmic assessments encompass various modalities and involve a substantial amount of imaging data, it is essential for statistical reporting teams to carefully synthesize and deliver thoughtful presentations. Furthermore, when dealing with rare indications and ophthalmic Cell and Gene therapy studies, it is imperative to develop efficient and meaningful patient profiles and statistical presentations as important considerations.

Join this webinar to gain insights into ophthalmology clinical trials’ statistical data strategies and learn on best practices for establishing and reporting ophthalmic data.

Speakers

Maria Abraham, Sr. Manager, Biostatistician, 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.

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Supriya Menezes, Associate VP, Ophthalmology Center at Emmes

Supriya Menezes, MS, Associate VP, Ophthalmology at Emmes, brings over 18 years of experience serving as a Emmes corporate leader and currently serves as the Principal Investigator (PI) for the National Eye Institute contract. Ms. Menezes has over 20 years extensive experience in biostatistics with a strong focus in ophthalmology rare indications and cell and gene therapy studies. Ms. Menezes serves as the independent reporting Biostatistician and oversees a number of biopharmaceuticals biostatistical clients.

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