Clinical Trial Data Xcellerate Informatics Covance Blog

Real-world evidence applied in real-life case studies

Real-world evidence (RWE) can be used to meet different objectives, and RWE studies can be designed using different study types and methodologies, as well as multiple sources of real-world data (RWD). Teams often work separately and could benefit from a shared learning experience in the planning and execution process. A publicly-available RWE framework tool was recently released to help enhance collaborative efforts in RWE studies.

Earlier blogs in this series discussed closing the knowledge gap with RWE studies and how Covance and industry professionals worked to develop an RWE framework tool. This third and final blog further explores how the tool was applied in actual case studies to better support RWE efforts in treatments for diabetes and pain management.

Supporting a diabetes RWE study

The first case example is for a novel oral antidiabetic medication. To better design a post-launch strategy, the team looked for effectiveness and outcomes but found there were no available RWD for Europe; most current data are largely from U.S. sources.

To consider possible options to support RWE generation in Europe, the team used the RWE framework tool to document the following research objectives and outcomes of interest:

  • Inform internal decision making related to business strategy.
  • Demonstrate product value to payers and providers.
  • Understand treatment pathways and patterns, clinical outcomes and health care utilization in a real-world study.
  • Given the product would be approved in the indication at study initiation and the study conducted in routine practice, the framework asked to consider if the data of interest are recorded in routine practice. By selecting “yes,” the team was presented with some possible secondary data options to consider. Additional questions asked us to specify if the target patient population for the analysis could be identified in existing datasets along with the required data variables.

The final section of the framework allowed the team to think about the specific study design. Based on this exercise with the tool, the team decided to create a retrospective study with a cohort design and use electronic medical records, as well as some national registries, for RWD.

Understanding the real-world impact of a patient self-administered pain treatment

The second case study involved a recently launched portable, non-opioid inhaler for moderate to severe trauma pain. The sponsor wanted to help the device maintain market presence. There was an absence of evidence around outcomes and resource use impact of the product in routine clinical practice. However, the product had already been launched in Australia for a number of years, a factor that would play into the decision-making process.

Using the RWE framework tool, the following research objectives and outcomes of interest were identified:

  • Inform business strategy and indication selection.
  • Demonstrate product value to payers and providers.
  • Understand clinical and economic outcomes among different injury types in a real-world study.
  • When studying pain medications, it is helpful to gather data on the patient experience, in addition to resources and cost. The team knew that pain scores aren’t always recorded in routine practice. The use of the framework helped the RWE team to identify the need for primary data collection for this study. As a result of leveraging the framework, the team recommended using a cohort design for a prospective observational study or survey, perhaps coupled with retrospective data, such as from chart review.

Creating a coordinated RWE strategy

These case studies show the value of brainstorming with the RWE framework tool and how the exercise can help fortify study planning for evidence generation. Ideally, this tool can be one component of a series of initiatives that a company might undertake to enhance internal RWE capabilities and facilitate discussions with key opinion leaders or external partners about its RWE strategy.

Other initiatives may include conducting internal assessments of interest and identifying knowledge gaps in RWE topics, creating multidisciplinary RWE working groups, and pursuing common data licensing/sourcing. The RWE framework tool can help companies guide training activities and to facilitate greater interactions across departments.

Enhancing RWE capabilities

By replacing ad hoc RWE study planning processes, we hope the RWE framework tool can be part of a more robust approach that captures a broad range of study types and objectives and helps set up successful, efficient RWE studies.

For more on applying RWE in real-life case studies, check out the webinar “Enhancing Study Design with a Real World Evidence Tool.”

If you have questions about the framework and/or would like to speak with a Covance Market Access and RWE specialist about your needs, contact us or to learn more about Covance Market Access visit us at

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