For cancer researchers, there is definitely power in numbers. For example, the Oncology Research Information Exchange Network (ORIEN) has grown into an alliance of 18 cancer centers powered by the informatics platform of M2GEN, a company formed out of the Moffitt Cancer Center in Florida. The network allows researchers to share data and collaborate more seamlessly across institutions.
In a recent interview Healthcare Innovations spoke to Stephen Edge, MD, director of the Clinical Oncology Pathways program at Roswell Park Comprehensive Cancer Center in Buffalo, NY and a member of the ORIEN Executive Committee.
HCI: Can you describe the value of ORIEN membership for a cancer center like Roswell Park?
Edge: In general, the value of ORIEN lies in its ability to combine both the clinical and genomic information, as well as scientific expertise, from cancer centers across the country to develop an understanding of cancer biology. ORIEN is one of several similar organizations attempting the same thing. The cancer centers participating in ORIEN submit sequenced tissue and germline data and couple this with high-quality clinical data. This data is then available for joint research. The data will also be used in a fully anonymous manner with researchers, both ORIEN members and non-profit organizations.
HCI: Can you tell us something about the origins of ORIEN?
Edge: ORIEN began working at the Moffitt Cancer Center eight or nine years ago and grew to include the state of Ohio and expanded over the following years and we now have 18 member institutions and the organization is looking to add more cancer center members. A number of centers have recently expressed interest in participating and this is not only ideal for the large NCI accredited cancer centers but also a good opportunity for other academic and community based centers. There are many very large centers with very robust programs that may not be NCI-designated or university-based. Therefore, it is an opportunity for their clinicians to get involved in this type of scientific endeavor.
HCI: Are there challenges in standardizing the data pulled from electronic health records?
Edge: The data is pulled from structured information as much as possible, but honestly as with all these types of datasets, there needs to be human curation, and human curation is a code word for human abstraction, meaning someone goes into the data and graphs it abstracts the data. We still partially rely on human abstraction of data to ensure we have high quality data. But one of the hallmarks of the ORIEN program is that we not only have the semantic information from the tumor, we have germline data, and we have highly curated and reviewed clinical data associated with these samples, and that includes follow-up information, especially survival and recurrence. This information can be difficult to obtain, especially when someone moves to another location or a patient moves to another center.
HCl: I understand that the process by which patients are enrolled is referred to as the Total Cancer Care (TCC) protocol, which standardizes the enrollment process across 18 centers. Why is this standardization important in registration and how was this protocol developed?
Edge: It grew out of the program that originally took place in Moffitt and then in the state of Ohio, and is a means by which people living with cancer can consent to opt-in and their clinical information and any associated biological information use. There are around 250,000 people enrolled in the TCC. A subset of these recordings actually contain tumor tissue available for sequencing. It’s a huge, huge dataset. I remember meeting a few years ago with one of our scientists who was interested in soft tissue sarcoma, a relatively rare tumor. I don’t know the exact number, but the Cancer Genome Atlas had a few hundred cases. ORIEN already had 1,000. So even with some rare cancers, there is a power in having these 18 centers working together.
HCl: Does this help people who focus on research into certain types of cancer to work together across organizations because they can share common data and maybe jointly develop projects around that data?
Edge: Absolutely. One of the hallmarks of the ORIEN group are the intermember projects, where a researcher at one of the member institutions proposes a study. ORIEN’s Scientific Review Committee reviews this and may comment to improve it. And then it can be available to scientists from across the network. So you don’t just have the data from your own center, you have data with curated clinical information on a larger number of people.
HCl: Does ORIEN also accelerate the development of clinical trials in partnership with pharmaceutical companies?
Edge: Yes. It’s still never a quick process. We all want it to go much faster. But again, one of ORIEN’s hallmarks is the ability to get that job done, and we recognize that we have areas where we can improve that efficiency. The Executive Committee and Steering Committee, in collaboration with M2GEN’s management, are looking at ways to significantly streamline this function.
HCI: Coming back to my question about data standards, I interviewed people at MITER who are helping to develop a common data model in oncology called mCODE. Is that something that could help your processes?
Edge: It could be, but mCODE would need to be fully available and used by different EMRs. The “M” in mCODE stands for minimal. It’s the minimal dataset required to have a standardized ontology dataset, but it’s by no means the complete dataset of things people might be interested in related to cancer. So far, mCODE has not yet become widespread and is not used in health records across the country. However, the standardization of clinical data will be crucial not only for patient care but also for clinical and scientific research. It is unfortunate that our industry lags far behind other industries in standardization. Even competing banks generally use the same language to speak to each other. On the other hand, if you have Cerner, Allscripts, or Epic, you can’t talk to each other, or quite frankly, different instances of one of those EMRs sometimes can’t even talk to each other. They’re all getting better at enabling this kind of interoperability, but progress is slow.
HCl: Is there anything else you would like to tell our readers about ORIEN?
Edge: I think it’s really a testament to people with cancer that 250,000 people have signed a consent form allowing their data to be used in this way. And yes, that’s a big effort on the part of the cancer centers that have done this. But it really is a testament to people’s willingness to allow their data to be used in these altruistic ways. The advances that may or may not result from the use of their data will be years away from the actual treatment. What ORIEN has done is leverage the large patient populations of all these centers to be available for this type of research. Now ORIEN and M2GEN are looking at how to speed up the return of this information and with proper legal and human oversight protections, return some of this information to the people. I think that’s a feel-good story about the large number of people participating in this research.