Author: Heather Grey, SVP/GM of RWD and Clinical Trials, Omega Healthcare
At two recent poster sessions co-presented with partners Memorial Sloan Kettering Cancer Center (MSK) and Dana-Farber Cancer Institute (DFCI) at the AACR Annual Meeting 2024 and the Cancer Center Informatics Society 2024 Summit & Clinical Trials Workshop, Omega Healthcare shared details of a unique and aggressive project to deliver high-quality real-world data (RWD) for more than 6,000 cancer patients.
The collaborative effort between MSK, DFCI, and Omega Healthcare was designed to curate structured RWD for oncology research. The project aimed to contribute to Phase 1 of the AACR Project GENIE Biopharma Collaborative (BPC), which provides a publicly accessible cancer registry of real-world clinico-genomic data. MSK and DFCI are two contributing sites for the collaborative and partnered with Omega Healthcare to create a hybrid operational model for curating RWD, using a common data model.
Real-world data provides insights to improve clinical decision-making and support research findings. Researchers, life sciences firms, and health tech companies need to focus on generating new insights and harness the economic potential of RWD to push innovation forward.
Clean, usable data is not the norm in oncology, and this needs to change. It is not only researchers and clinical trial principal investigators who struggle with this. Clinicians – those in the clinic every day, seeing patients and trying to make treatment decisions – routinely suffer from lack of access to enough clean data.
Structured RWD for oncology research is critical and in short supply, but researchers often lack the time and resources to curate data in-house. And this is where Omega CurateIQ comes in.
Omega CurateIQ (formerly Vasta, acquired in 2022) cleans and curates data to create usable data formats for clinicians and researchers to use daily. Omega Healthcare does not keep copies of or rights to any data that it is entrusted with to curate. This allows researchers to truly trust Omega Healthcare with their data – without giving up any rights – and to receive clean, usable data in a uniform format to support their work.
Working with a partner like Omega Healthcare enables researchers to curate RWD in a cost-effective way, while remaining focused on core research responsibilities. Such an initiative requires strong collaboration and constant communication, but relieves sites of managing the entire data curation process alone.
Challenges in Real-World Data Curation for Oncology
The challenges encountered in this collaboration mirror those of the industry at large. When we talk about healthcare industry challenges, staffing is typically a logical starting point. Staffing issues have always been prevalent in healthcare, whether it is due to sites being understaffed or staff attrition, and today they have reached a critical point.
Medical data curation is a field with high turnover in the United States. Every time someone leaves, a new team member must be hired and trained. When there is considerable churn in staffing, the data quality often suffers. In order to create a consistent, usable, repeatable data set, researchers and clinicians need to embrace an outsourced staffing model where the researcher or the site never feels any type of staff turnover or need to hire.
Omega Healthcare has the ability to fill the gaps caused by staff attrition with a 1,300-person team in India – professionals with advanced degrees, often in medicine, who manually clean and curate the data so researchers have data formats that are repeatable, traceable, auditable, and ultimately usable for physicians, pharmacists, and healthcare data aggregators. Removing this burden from the sites allows researchers and clinicians to focus on the higher, more important tasks of research – getting to their endpoints more quickly – without having to focus on cleaning and curating data before beginning their research.
Key Success Factors: Communication, Cross-Training, and Quality Assurance
The programmatic approach applied in this project not only involved Omega CurateIQ and staffing, but critical success factors such as clear communication, cross-training of curators, establishing quality assurance and delivery methods, and developing data visualizations and analytics.
The results demonstrate that the collaboration helped MSK and DFCI deliver high-quality RWD for 6,475 patients in Phase 1 of the AACR GENIE BPC. Success factors included clear communication, cross-training curators, establishing quality assurance and delivery methods, and developing data visualizations and analytics. The Omega CurateIQ flexible staffing model is centered around a highly trained and experienced team of experts with over 80% holding a master’s degree or higher and more than 70% holding a medical degree. The results demonstrate that the collaboration helped MSK and DFCI deliver high-quality RWD for 6,475 patients in Phase 1 of the AACR GENIE BPC. Together, the teams decreased curation time and added new cohorts as they gained experience, maintaining project pace despite challenges posed by the pandemic, remote work, and staffing changes.
Lessons Learned and Future Implications
Reflecting on the success of the project, Grey notes some key lessons learned about cost-effectively scaling RWD curation and how those insights shape the future of RWD utilization in oncology research. Among the takeaways:
- Clean Data is Paramount – The chief lesson learned is that clean, usable data results in better patient outcomes. Structured RWD for oncology research is critical to clinical decision-making as it facilitates the identification of trends and correlations that might not be apparent in unstructured data.
- Partner for Success – Researchers and clinicians do not have to do this alone. Sites that are working on their own to create clean data from their own sources can benefit from sharing across sites, sponsors, and data aggregators. There is an opportunity to generate clean data that everyone can use to serve patients better.
- For Drug Discovery, More is Better – Drug discovery relies on as much data as can be found. The only way to add to the data pool that drug discovery needs is to continue to clean and curate data – not just existing data in databases.
- Start With Common Data Models – Data drawn from disparate sources is typically in different formats – making it difficult for researchers and clinicians to use. The key to future useability is common data models.
- AI is Making Advances – While AI is gaining prominence in healthcare, it has not proven effective enough to be used on its own for decision-making in research or clinical settings. Omega Healthcare is working to advance the clinical applicability of AI by working with partners to help validate their AI models, building manually curated and accurate test data sets so that AI builders can test their models against and make adjustments. Omega Healthcare is also building its own generative AI models with its data curators – building them in conjunction with what the manual curators are generating to create efficiencies without sacrificing the accuracy that is key to clean data. As this ability scales, Omega Healthcare will produce cleaner data faster, and at lower prices.
- Patient-Grade Data is Lifesaving Data – Regulatory- and research-grade data are important and necessary for drug discovery, and both require clean data. But patient-grade data is equally important. We need patient grade data – data that clinicians can look at when they have that singular patient in the office and are making treatment decisions. It is essential to better outcomes, and empowers physicians with the ability to make immediate, life-saving decisions at the point of care.
These key takeaways underscore the critical role of clean, usable data in oncology research and patient care. By collaborating with partners like Omega Healthcare to curate real-world data, researchers and clinicians can access the information they need to drive innovation, improve clinical decision-making, and save lives.
Every patient curated through Omega CurateIQ gives the next similar patient the ability to have more data available – for better clinical decisions, more options for treatment, so the entire Omega Healthcare team is very proud of its contributions to this effort.