Advancing Real-World Data to Improve Oncology Care

Real-world data and analytics company, COTA, Inc has been working closely with Miami Cancer Institute, Hackensack Meridian Health, John Theurer Cancer Center, Reginal Cancer Care Associates, and pharmaceutical partners to support real-world data from leading academic and community-based cancer centers.

Recently, the company announced a new president and CEO, Miruna Sasu, whose vision is to continue the important work with a special emphasis on drug development, improving treatment decision-making, and closing equity gaps in cancer.

“Since joining the life sciences community more than 20 years ago, I’ve been deeply passionate about using real-world data to inform drug development of effective treatment and [aid in] decisions at the patient’s point of care. [Real-world data] is the essential connective tissue of the research environment, bridging gaps between partners in life sciences and clinical care,” said Sasu, in a statement. “Real-world data doesn’t just help us answer questions. It helps us ask the right questions for the right people at the right time, so that everyone can get the most precise, personalized care for their unique needs.”

According to the company’s chief medical officer, C.K. Wang, MD, COTA has been very successful in aiding in drug development and improving cancer care overall.

In an interview with Targeted Oncology, Wang, who’s also an adjunct assistant professor at UT Southwestern Medical Center, discussed the importance of real-world data in oncology, the mission of COTA, and research the company has been a part of.

TARGETED ONCOLOGY: Can you talk about real-world data in oncology? Why is it important and how does the informationa we get from these studies differ from other clinical trials?

Wang: I think it's probably worthwhile to start by defining real-world data, which is any health care data that is collected outside of a clinical trial setting. And the reason why this is important is that clinical trials are conducted under very rigid protocols. And they're in patients who are treated in a very controlled setting. However, as we all know, the majority of patients, not just cancer patients, but patients in general, are not treated on clinical trials. And in fact, in oncology, only about 3% to 5% of cancer patients are ever enrolled on clinical trials. So as a result, you see this well controlled data that is being used for a drug approval to being used in the real world, which we really wish could be very different than the clinical trial world.

And so, as a result, we feel that there is a lot of insight that we could derive from what is happening in the real world. And that real-world data essentially can provide us with a more representative and holistic view of the patient experience, and a more realistic perspective on patient outcomes, or rather, to validate the patient outcomes that we see in clinical trials. Just to remind everyone here, this is the initial promise of migrating medical documentation to the EHRs, right, that all of a sudden, clinical data will be in a technology that can be mined.

So, what we're doing here at COTA is we are realizing that promise of all the clinical documentation. And in recent years, since the passage of the 21st Century Cures Act, in the oncology clinical trial space, especially real-world data is helping pharmaceutical sponsors to better understand disease, this treatment landscape, and in very specific cases, is actually being used to help support single arm clinical trials.

How does COTA's real-world data differ from what oncologists can get from cancer registries?

There are there are many sources of real data, and cancer registries are one of them. However, cancer registries are typically developed for very specific-use cases. Therefore, not all of them can be used for all different-use cases. Whereas clinical real-world data, which is what COTA works on, is a more generalized approach to collecting raw data so that the data could be used to support multiple different-use cases.

So, registries are good, but most of them are developed or many of them are developed for very specific-use cases. Therefore, they can only be used in that one specific scenario.

Can you discuss any recent successful clinical trials involving COTA, Inc?

COTA supports clinical trials, and what we do is we license our data or wearable data to help support ongoing clinical trial studies and one of our most recent success story here at COTA is that our real-world data set in multiple myeloma was used to support the filing and the approval of a first-in-class multiple myeloma CAR T-cell therapy, and that was in 2021. We currently are supporting multiple ongoing clinical trials, many of them are in hematologic cancers.

Recently, the company named a new president and CEO, can you discuss any Initiatives planned by new the leader that could push your research efforts forward?

I think there are multiple goals that our new CEO has established. First and foremost, is to continue to expand the use case of real-world data. She has very deep experience in this field. And what we're looking to do is to continue to expand the completeness or the breadth and scope of the COTA real-world data to bring in different data elements to supplement the clinical real-world data that we are known for.

We are continuing to work on expanding our capabilities and our support services to our life science partners, more specifically to help them with their data science needs. So, we’re not only supplying them with licensing data, but we help them with using that data as well. Lastly, on the topic of diversity, or lack thereof, in the clinical trial mechanism, that remains a big focus for the company, as well as our new CEO. So ,we will continue to partner with different institutions, different thought leaders to continue to advance this dialogue about issues in cancer care diversity.

If you could give a message to the oncology community about oncology research, what would it be?

Something that I think is important to highlight is this concept of precision oncology. Precision care is everywhere, not just in cancer, but in health care in general. I think that, especially in oncology, I just want to remind everyone that only a small fraction of patients with cancer have mutations that are targetable by drugs. Under this terminology, the concept of precision medicine, and so by default, the majority of patients are excluded from that discussion of precision medicine and precision oncology.

And we want to remind everyone, we feel very strongly here at COTA that there is tremendous insight that is hidden within the clinical documentation that is generated from everyday patient care, and that those insights could help us care for those patients that don't have these targetable mutations. We at COTA feel very strongly about our mission of providing clarity to everyone touched by cancer and providing them a clear path to the right care. That is our definition of precision oncology: not care for the select few, but care with the right care and for the entire cancer population. So, that's one thing that I really would like to emphasize.