This year’s ICPE unveiled many insights for Flatiron Health's Real-World Evidence team to carry forward into our work to reimagine the infrastructure of cancer care. We’re sharing our top three below:
1. Real-world evidence continues to have a positive impact on regulatory applications in oncology
There was a clear theme at ICPE 2023 on the positive impact of real-world data and evidence (RWD/E) inclusion for oncology drug development and post-marketing commitments.
As showcased in the keynote plenary session “Town Hall: Global Regulatory Forum on Real-World Evidence,” there was consistent agreement among regulators across multiple countries (US, Canada, EU, Israel, Japan) during the panel discussion moderated by FDA’s Robert Califf, that oncology and rare diseases are the top two areas where RWD/E is most immediately applicable.
That theme was further emphasized in multiple examples shared by individual regulators, predominantly using oncology as their illustrative therapeutic example. For instance, the FDA’s Donna Rivera walked through an oncology example highlighting the need to have the right research question paired with adequate and well-controlled data, emphasizing the need for “fit for purpose” research.
Interestingly, despite the acknowledgement of the importance of RWD/E in oncology, Flatiron attendees noted a disproportionate lack of oncology-focused research and perspectives being presented in ICPE sessions.
These observations not only underscore the criticality of developing integrated RWE solutions, but also signals the need for Flatiron to be more proactive in discussing and presenting methods, approaches and study results specific to oncology in future conferences.
2. It’s no longer a question of if artificial intelligence should be used in real-world evidence research, but how it should be used
Artificial intelligence (AI), machine learning (ML), and natural language processing (NLP) were terms used often in discussion of research presented as well as the direction that RWD/E methods are heading. In the plenary session, the FDA noted that it wasn’t a question of if AI/ML/NLP should be used in RWD/E research, but how to use it in an appropriate and responsible manner. They emphasized the necessity of transparent and traceable model development, along with assessing the underlying model quality prior to interpreting research findings.
Across many posters, talks, and workshops, researchers described safety-based analyses which utilized claims or spontaneous report databases but lamented the inability to be able to go into patient charts to contextualize the results—a gap that Flatiron is well-positioned to bridge with our ML capabilities. Our poster presentation “Unlocking the patient journey: Comparing machine learning (ML) based natural language processing (NLP) and expert abstraction in understanding treatment patterns” showcases how we can use ML to accelerate evidence generation for oncology.
3. Advancing health equity and clinical trial diversity continues to be a key priority, particularly in drug safety and post-marketing commitment studies
There were several specific groups of presentations focused on insights and approaches to health equity and clinical trial diversity. Flatiron presented two studies at ICPE on this topic, “Structural racism and inequities in real-world treatment and survival among patients with four solid-tumor cancers'' and “Mediators of racial/ethnic inequities in clinical trial participation among US patients with cancer, 2011-2022.”
These studies explore the underrepresentation of racial and ethnic groups in cancer trials while examining the impact of structural racism on treatment initiation and survival rates for specific cancers.
Health equity and trial diversity persist as key topics of interest among the life science industry. Flatiron will continue channeling efforts into integrated RWE solutions and research to assess disparities in healthcare access, diversity in clinical research, and outcomes in cancer treatment.
To learn more about how Flatiron’s Real-World Evidence team is transforming the possibilities of oncology research, development, and commercialization, reach out today.