The real world is an unpredictable place. It can be messy and confusing, full of challenges and uncertainties that have to be overcome before we can move forward with confidence and clarity toward our goals.
The same is true of the real-world data (RWD) generated by clinicians, health plans, medical devices, patients, and more. Before we can use these data elements as real-world evidence (RWE) for outcomes of interest, we have to answer some key questions.
What is actually in those datasets? How often are care providers collecting sufficient data at key points in the care journey? What processes are being used to extract, aggregate, and analyze those high-value elements, and how can we get more consistent with those tasks over time?
In short, what value can we really get out of RWD, and how can we best apply that value to the research environment to produce optimal results?
These questions are too big and too complex for any one company to answer on their own. That’s why the non-profit Friends of Cancer Research has convened an impressive coalition of data companies, life science companies, academic organizations, provider groups, and others to share their knowledge and resources in pursuit of effective cures.
Since 2018, Friends of Cancer Research has conducted a series of pilots designed to better understand the utility of RWD and RWE for research applications, starting with work to establish shared endpoint definitions and continuing with projects to evaluate the consistency of RWD and its potential to generate reliable, meaningful evidence.
COTA has dedicated our expertise to this mission since the beginning, even working closely alongside our business competitors to achieve our shared objective of bringing the power of RWD to the life sciences and clinical communities – and ultimately, to the patients in need of more effective, accessible therapies.
The latest phase of this collaboration brings the industry closer than ever to understanding the reliability and consistency of RWD to be used in research applications, specifically in use cases related to non-small cell lung cancer (NSCLC).
In August, new research published in JCO Clinical Cancer Informatics found that RWD harmonized across sources to an aligned protocol demonstrated reasonable consistency in real-world response assessment.
In other words, oncologists treating patients in the real-world setting are documenting response to treatment on a regular frequency, and with enough clinical detail, to be useful for researchers, even though these oncologists and patients aren’t enrolled in clinical trials.
The study also shows that different data companies are processing information in a relatively consistent manner to produce consistent results despite some differences in proprietary methodologies.
“These results give further confidence in the use of real-world information to augment and enhance insights from traditional clinical trials,” according to Andrew Belli, VP of Research at COTA. “Researchers using RWD can gain access to broader and more inclusive datasets that are representative of actual populations of cancer patients, helping to ensure generalizability of results.”
It also means that researchers can trust that data companies are remaining in alignment with one another as we all work toward developing industry standards for the use of RWD in research projects. Building and maintaining this trust is critical, since a strong, transparent, and collaborative partnership between a data company and a research entity is key for success in an increasingly complex data environment.
“We can’t overstate the importance of this type of collaborative, forward-thinking research into advancing the use of RWD. We believe it is essential to take a leadership role in this ongoing conversation, and COTA is proud to be a part of the Friends of Cancer Research community as well as other industry partnerships and collaborative organizations,” Belli said.
COTA’s work in this area is ongoing, so stay tuned for some exciting new developments as we pursue the next steps toward harnessing the enormous potential of RWD and RWE for cancer research.
