Navigating Biometrics Challenges in Ophthalmology Clinical Trials: Lessons Learned

Clinical trials in ophthalmology represent a crucial frontier in advancing treatments for vision related conditions. Ophthalmology development teams face unique challenges that shape the trajectory of research and ultimately impact patient outcomes through their data collection methods. 

As the focus of biometrics and clinical data science, researchers delve deep into understanding what the data is telling product teams and determining the best approach for organizing it to facilitate telling a compelling story for both participants and researchers. While data collection methods are strategically aligned with protocol and schedule of events, there remains the challenge of ensuring the data reflects truth – especially in ophthalmology clinical trials. 

Our experts break down the key lessons learned from navigating clinical trials focused on the eye. 

• Interpreting Numeric Values Requires Context: Numeric values in ophthalmology data may not always convey straightforward meanings. For instance, a value of '0' could signify various factors such as the absence of an image or poor image quality, rather than indicating a specific outcome as in other medical fields. Biostatisticians must contextualize these values to avoid misinterpretations. 
• Accurate Data Processing is Key to Meaningful Analysis: The processing and interpretation of ophthalmology data presents unique challenges relative to some study designs. Biostatisticians must carefully process data, maintaining consistency in interpretation while considering factors such as image quality and patient characteristics. This ensures that the data accurately reflects the intricacies of the trial and facilitates meaningful analysis. 
• Collaboration Enhances Data Integrity: Collaboration between data managers, biostatisticians and ophthalmological clinical researchers is essential in designing case report forms (CRFs) and data collection methods. By working together, these teams can design CRFs that capture essential information while minimizing errors and inconsistencies, ultimately safeguarding the integrity of the clinical data. 
• Ensuring Data Accuracy Through Strategic Recording: While 'query' might seem like a loaded term, it's indispensable in maintaining data integrity. In ophthalmology, accuracy hinges on knowing when to rely on site-recorded data versus results interpreted centrally. Some parameters can be reliably assessed and recorded by certified clinic staff during patient visits. However, for others, despite being imaged at the site, their most accurate determination often necessitates evaluation by a central, masked reader or interpreter. 
• Specialized Expertise is Essential for Data Interpretation: Identifying the occurrence of ophthalmological events of interest and interpreting imaging results in ophthalmology trials requires specialized expertise. Biostatisticians collaborate closely with ophthalmology and imaging experts to understand how to properly bring together the different data sources to achieve correct and objective analysis. 

Navigating biostatistical challenges in ophthalmology clinical trials requires a nuanced approach and a commitment to precision, collaboration, and continuous learning. By embracing these lessons learned, development teams can help drive meaningful insights and advancements in vision care, ultimately improving outcomes for patients worldwide. 

Is your team exploring ways to advance clinical ophthalmology trials? Our team of experts partner with board-certified ophthalmologists, biostatisticians and clinical trial experts to accelerate exceptional ophthalmology therapies from bench side to patient side. 

Contributors

Heidi Paone | Manager, Clinical Data Science

Lisa Reeves | Principal Biostatistician