Janet L. Espirito, PharmD, Senior Medical Director for Ontada, speaks with the Journal of Clinical Pathways about the significance of her research on real-world response endpoints in patients with mNSCLC treated with chemotherapy across real-world datasets. The study was presented at the 2023 ASCO Annual Meeting in Chicago, IL.

Transcript:

Can you give some background about your study and what prompted you to undertake it?

Janet Espirito: We were very excited to collaborate on this study with the Friends of Cancer Research Organization, and the purpose of the study was to identify methods to evaluate real-world response using real-world data. In terms of background, we know that response to therapeutics in oncology is traditionally measured very uniformly in clinical trials and very protocol driven. In the real world, however, there is heterogeneity in terms of how patients are managed, and there is no consensus approach in terms of how to measure response, unlike in the clinical trials. So, the objective was really to inform development of how to use real-world data in order to be able to assess real-world response using real-world data.

Can you briefly describe how the study was conducted?

Janet Espirito: Sure. In collaboration with seven other electronic health record data partners, the groups met and developed a standard protocol and statistical analysis plan to identify an aligned population for which we would all analyze and then look to see what the results were, to learn about the availability of data as well as the findings using real-world data.

What were the key findings of your study?

Janet Espirito: The key findings were that despite having seven different electronic health record data partners, we were able to observe consistent findings across all data sources in real-world response rates. We looked for three different types of data to be able to assess response. First was the availability of images, the actual raw images. The second was the availability of imaging reports, and then the third was the use of clinician assessment of response. We did learn that the availability of the raw images was not consistent across all the data partners, but the imaging reports and clinician assessment of response was, so therefore, utilizing that methodology, we were able to observe consistent response rates across all of the data partners.

Looking ahead, what potential impact do you hope your findings will have?

Janet Espirito: Well, the good news is that this demonstrated the feasibility of being able to assess real-world response using clinician assessment and using real-world data. Looking ahead, the goal is to develop some best practices in terms of recommendations such that when organizations are seeking to assess this endpoint using real-world data, that there can be consistency of the approach and also further exploration to see how real-world data can continue to be used to support decision making.

Is there anything else you'd like to add? Any final thoughts?

Janet Espirito: Once again, I think certainly real-world data is growing in interest and importance in terms of being able to understand effectiveness of therapies in larger populations outside of clinical trials, so we are very pleased that we were able to collaborate with other partners and help advance this area of research.