Real World Evidence (RWE) Studies assemble patient outcomes information resulting from normal medical practice among diverse sets of patients. Data sources might include insurance claims, electronic health records, and other sources. Evidence derived from normal clinical practice outside of clinical trials, can be seen as a way to tailor health care decisions more closely to individual patients and a small step forward in personalizing healthcare for individual patients.
Observational Prospective Studies
Robust RWE studies will not only tap increasing volumes of data, but weave together different data sources including clinical, genomic, and socioeconomic in order to yield a more complete measurement of individual patient characteristics and potentially improve the impact of health care interventions on individual patient needs. RWE studies can be either prospective, retrospective, or a combination of both under certain circumstances.
Frank R. Ernst, PharmD, MS
Executive Director, Health Economics and Outcomes Research
Frank brings nearly 20 years of experience developing, conducting, managing, and disseminating pharmacoeconomic, outcomes, utilization, and market research studies across a variety of clinical therapeutic areas and healthcare settings. His experience and expertise includes medical chart review studies, retrospective hospital and claims databases, registry data analyses, and more. He is experienced with regulatory and legal requirements for conducting research under HIPAA, HITECH, and OHRP guidelines.
Prospective RWE studies include:
- Health resource utilization data collected within or derived from the results of randomized clinical trials (RCTs)
- Clinical setting data obtained directly through electronic medical records (EMRs)
- Clinical chart reviews where EMRs do not yet exist
- Patient registries
- Phase IV RCTs
Observational data are often required to meet complex directives from global regulators and payers to demonstrate real world product value, safety, and effectiveness. In the absence of suitable sources of robust clinical data (e.g. literature, healthcare databases, electronic medical records), it may be necessary to engage in primary data collection to generate the appropriate clinical evidence.
CTI’s HECOR team can design and execute observational studies that are tailored to each treatment in order to demonstrate the real-world effectiveness of new healthcare interventions. CTI’s HECOR team has experience with many datasets from around the world. Our researchers can rapidly assess a client’s product needs and recommend available databases and data sources sufficient to produce the best information to meet those needs.
We understand and are able to analyze large claims databases and electronic medical records as well as combinations of these along with other data sources. When retrospective data are insufficient, we can supplement those with prospective data collection where and when appropriate.
Claims and Retrospective Database Analyses
Administrative health claim records and other clinical databases provide an abundant source of real world experiential data for our pharmaceutical, medical device, and diagnostic clients to glean important insights into clinical outcomes and disease-related cost offsets associated with their products. CTI’s HECOR team utilizes a wide range of statistical and analytic methodologies which provide our clients the opportunity to fully assess the impact of a new healthcare technology on everyday patients.
CTI’s HECOR team has experience in extracting usable datasets and performing a wide range of statistical analyses arising from a multitude of administrative claims and clinical databases as summarized below.
- Payer Databases
- Hospital Databases
- Electronic Medical Records
- Clinical Databases
Candace Gunnarsson, EdD
Vice President, Health Economics & Outcomes Research
Dr. Gunnarsson has over 20 years of statistical and health economics experience, including data mining, statistical analyses, and economic evaluation services for pharmaceutical, diagnostic, and medical device companies. Candace’s experience in statistics and health economics has added great depth to our Health Economics & Outcomes Research team.
CTI’s HECOR team assists our clients in assessing clinical outcomes research needs for a new or existing healthcare technology and match those to the most appropriate database to acquire Health Insurance Portability and Accountability Act (HIPAA)-compliant patient records for analysis.