Analysis of Accurate Real World Data to Support Informed Strategic Decisions
Vector Oncology’s HEOR business line, created in 2005, conducts studies involving health outcomes and economic endpoints, including prospective observational research, cross-sectional survey studies, and retrospective studies utilizing our aggregated data. Our Data Warehouse is a repository of electronic medical records, billing data, and patient-reported outcome data from geographically diverse community oncology practices. Our team has many years of oncology research experience with an exceptional understanding of oncology specific treatment delivery models. Vector Oncology provides gold standard quality data drawn directly from electronic medical records and billing systems in community oncology practices. This data includes physician progression notes and other text documents that provide detail critical to accurate classification and analysis in many research studies. Augmenting the structured data by mining the unstructured data is an established process that increases the value of our approach.
Ability to Conduct Patient Centered Research
The Data Warehouse contains clinical data regarding patients seen over the past decade across diverse community oncology practices. Our warehouse includes a repository of Patient Care Monitor™ (PCM) records, a patient reported inventory of symptoms experienced by the patient. Our health economics and outcomes team is then able to examine patient reported outcomes as part of retrospective and prospective research. Our established relationships with many practices that have participated in patient survey research allow us to answer research questions ranging from patient financial concerns to management of treatment side effects, to the patients willingness to pay for supportive care that may reduce treatment side effects. These research methods are utilized in Cross-sectional studies. Vector Oncology has the capability for prospective observational studies that collect patient-reported outcomes during and following treatment at defined intervals. As a real world research team with over a decade of experience, we have direct access to experienced experts across a wide range of clinical operations activities.
High-quality data repository of community based electronic medical records (EMR), billing data, and patient reported outcomes on up to 1,500,000 patients
- Over a decade of real-world patient data from geographically diverse community oncology practices
- Unstructured EMR documents backed by expert consensus providing gold standard values for key data elements
- Superior data mining platform and expertise
- Unique inclusion of patient-reported data from routine clinical practice
Our dataset includes approximately 1,500,000 patients, including more than 1,000,000 with identified cancer diagnoses. These data are drawn from geographically diverse, community oncology practices throughout the U.S., and represent the patients of hundreds of practicing medical oncologists. Vector Oncology has partnered with CancerLinQ to support Vector’s access to EMR data from certain of CancerLinq’s affiliated practices, which includes >100 cancer centers. With this agreement, Vector Oncology is positioned to offer a wider variety of real-world oncology research to help our clients demonstrate product value in the current market. Patient-reported outcomes data in our Data Warehouse are collected with the Patient Care Monitor™ (PCM) survey as part of routine care. We have the unique ability to mine more than 500,000 PCM survey records that are directly linked to EMR clinical data of cancer patients in our Data Warehouse, providing unparalleled insight into the symptom burden and health-related quality of life for patients with cancer. This unique asset will grow as we deploy the PCM into select practices in the CancerLinQ centers.
Vector Oncology’s HEOR capabilities also include statistical expertise to meet the needs of projects from beginning to end. The continuum of services provided by our experienced statisticians range from providing advice on study design and required sample sizes to deriving final results. Each member of our statistical team has broad experience in oncology and some of the unique challenges associated with analyzing oncology data, such as handling censored data. Our statisticians have extensive experience with studies with cancer-focused outcomes, including tumor response outcomes (response rate, clinical benefit rate), time to event outcomes (progression-free survival, overall survival), and toxicity and other adverse event outcomes.
Vector has completed projects using a variety of statistical methodologies including:
- Descriptive analysis
- Comparison of group means
- Survival analysis
- Multiple linear regression
- Multiple binary and multinomial logistic regression
- Ordinal regression
- Linear mixed models for assessment of longitudinal data
- Propensity score modeling for balancing nonequivalent groups
- Cost-related methods, including analysis of censored cost data
- Structural equation modeling for causal modeling among multiple variables
- Conjoint survey analysis
Statistical services provided by our statistical experts include, but are not limited to:
- Sample size calculation
- Identification of design alternatives and assessment of the impact of these alternatives on sample requirements, feasibility, timeline, cost
- Development of the analytic approach to match research objectives
- Preparation of written materials for protocol
- Development of a statistical analysis plan
- Generation of study results
Vector Oncology’s HEOR business line provides clients with economic analysis driven by in-depth clinical information available through unique data resources. Our health economics team has the capacity to provide reimbursement and economic information that extends well beyond typical drug trend analysis.
Vector Oncology’s Data Warehouse includes unstructured data allowing for detailed insight into drug trends and treatment patterns, including comprehensive descriptions of treatment regimens across multiple lines of therapy and reasons for therapy switch and discontinuation. Our unique dataset also allows for accurate identification of the timing of events, such as disease progression and disease recurrence. These clinical data advantages combined with economic resources enable the HEOR team to provide descriptive and comparative analyses of healthcare resource utilization and associated costs over defined intervals of therapy.
In addition, HEOR survey capabilities at Vector Oncology support alternative methods of deriving economic endpoints, such as the use of conjoint analysis survey methodology to derive patient willingness to pay. The advantages associated with Vector Oncology’s clinically and economically rich data resources combined with our research expertise provides our clients and partners with valuable real world evidence for making strategic decisions regarding their position in the industry and their approach to helping patients.
Medical & Scientific Writing
The Vector Oncology medical writing team has significant experience in the development of the full range of medical writing activities relevant to clinical trials and health outcomes research. This includes development of proposals, clinical study protocols, informed consent documents, through dissemination of interim and final study results. Our team’s expertise in oncology, from point of care to national reimbursement issues, can be utilized in consulting projects for our clients to assist them with their projects and strategic business decisions. Key dissemination-related medical writing activities include each of the following:
- Scientific Publications and Presentations Capabilities: Vector Oncology’s scientific and medical writing team has developed abstracts, presentations, and scientific posters for all major oncology and supportive care conferences in the US and Europe.
- Manuscripts:Vector Oncology has helped our clients in publications, book chapters, journal articles, and other scientific writing.
- Clinical/Statistical Reports: Vector Oncology provides sponsors with a depth of expertise which extends from actual in-practice research operations to meta-analysis of results by PhD level researchers.
Use of Real World Datasets for Regulatory Filings
Vector Oncology constructs synthetic cohorts to serve as external control arms in support of FDA/EMEA regulatory submissions based on the following:
- Access to a large repository of structured and unstructured EMR data.
- Ability to model the natural history of diseases, along with the effectiveness and safety of standard of care treatments.
- Precise case selection conducted according to study inclusion/exclusion criteria.
- Audit trail links each data element back to a source document or structured field for patient level verification
- Retrospective data sources with robust data curation delivers clinical research trial quality endpoints with major time and cost savings relative to traditional prospective/observational study designs
- Best in-class machine assisted human curation of unstructured data supports abstraction of key data elements from text documents (e.g. radiologic scan reports, pathology reports, physician progress notes)
- Curation activity is centralized and conducted by a professional staff of oncology research nurses
- QC processes are supported by a formal query process
- Ability to abstract date of progression based on MD documentation, radiologic scan reports, and other supporting documents
Screenshot of the User Interface Powering Machine-Assisted Human Curation
The Vector Oncology team conducts several types of studies involving health outcomes and economic endpoints, including prospective observational research, cross-sectional survey studies, and retrospective studies using data aggregated into the Vector Oncology Data Warehouse. We have conducted studies across a wide range of cancers, including high prevalence cancers, and lower prevalence hematological malignancies. Our researchers employ state-of-the-art analytics for use with secondary data in understanding practice patterns, treatment outcomes, patient reported outcomes and treatment costs. The combination of gold standard data, oncology focus, and our experienced research team make Vector Oncology a leading choice for oncology research.
Selected Vector Oncology publications and presentations:
1. Houts AC, Ogale S, Walker MS, Sommer N. Treatment patterns and outcomes in patients with KRAS wild type metastatic colorectal cancer (WTMCRC) treated in first line with bevacizumab (B) or cetuximab (C) containing regimens. In: American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI); 2016 January 21 – 23; San Francisco, CA; 2016.. view
2. Fisher MD, Pulgar S, Kulke MH, Pitmann-Lowenthal S, Cox D, Miller PJ, et al. Treatment outcomes in patients with metastatic neuroendocrine tumors: retrospective analysis of a community oncology database. In: National Comprehensive Cancer Network; 2016 March 31 – April 2; Hollywood, FL; 2016. view
3. Buck PO, Saverno KR, Miller PJE, Arondekar B, Walker MS. Treatment patterns and health resource utilization among patients diagnosed with early stage resected non-small cell lung cancer at US community oncology practices. Clinical Lung Cancer 2015;16(6):486 – 495. read
4. Mitchell AP, Harrison MR, Walker MS, George DJ, Abernethy AP, Hirsch BR. Clinical trial participants with metastatic renal cell carcinoma differ from patients treated in real-world practice. Journal of Oncology Practice 2015; 11(6): 491-497. read
5. Walker MS, Pohl GM, Houts AC, Peltz G, Miller PJE, Schwartzberg LS, Stepanski EJ, Marciniak M. Analysis of the psychological impact of cancer-related symptoms on patients with non-small cell lung cancer. Psycho-Oncology 2016 Jan 20. doi: 10.1002/pon.4071. [Epub ahead of print]. read