Analyzing Real World Data Sources and Evidence

Synergus’ database of RWD and RWE

To address an unmet need with accessibility and an overview of RWD and RWE for industry, Synergus has developed a framework to collect and analyze real world data sources and evidence in Europe. This database of European real world data sources and evidence, originated from these sources, in particular disease or procedural areas.

Real World Data Sources

The first part of the solution is a repository of real world data sources, which includes both patient registries and claims datasets, although the primary focus on the database is data-rich patient registries. The scope includes registries, developed or sponsored by government (e.g. Hospital Episode Statistics (HES) or Heart Failure Audit in the UK), clinical societies (e.g. transcatheter aortic valve registry in France) and independent organizations (e.g. international SITS registry for stroke, developed by Karolinska Institute in Stockholm). Each registry/dataset in the repository is marked with meta-tags for disease area, technologies used and country. Information about all variables used and specifics of methodology (including duration of follow-up, coverage etc.) is extracted. Finally, Synergus applies a de novo classification of level of quality of patient registries to identify data sources of greater quality. 

Real World Evidence

The second part of the solution is a database of publications, originating from included datasets and registries. Publications are obtained in several ways, systematic and comprehensive electronic searching in both Medline and registry websites, and correspondence with registry managers and authors of registry-based publications. For each record, information is extracted about data source used, primary research question, and year of publication. In addition, each publication is mapped to a specific type of question by health technology assessors (e.g. burden of disease, unmet need, efficacy etc.).

All data are linked in the database using meta-tags. This allows a quick exploration of any question about available data sources and evidence for a particular disease.

The developed framework has no analogous in Europe. The only publicly available repository of patient registries (PARENT, sponsored by EU Commission) has very limited coverage both in terms of number of sources included and available information.

Key value propositions of the RWD segment include:

  • Easy identification of data source with relevant clinical and economic data available
  • Easy selection based on available variables, quality, and geography

Key value proposition of the RWE segment includes:

  • Instantly available mapping of available RWE by different factors: country, disease, technology, HTA question (e.g. burden of disease, effectiveness), study research question (e.g. prediction study, etc.)

Industry partner per disease area

Synergus has heavily invested in the initial development of the framework and collection of data. We are now looking for industry partners who want to champion the insight into real world data/evidence for a specific disease area. Click here to see some of the summaries of the initial research.

The proposed framework may include the following activities:

  • Identification and assessment of real world data sources specific to the disease / intervention.
  • Search of real world evidence relating to the disease/intervention specific data sets and / or general electronic health records.
  • Review of publications to identify type of research question that is being answered as well as mapping to HTA questions.
  • Publications relating to the research such as:
    • Real World Data overviews
    • Identification of evidence gaps in HTA that may be answered by real world evidence.
    • Comparison of HTA results against real world data.
    • Utility of real world data in HTA

For the research regarding HTA, Synergus is using the proprietary my-hta database that includes more than 36 000 HTA records from Australia, Canada and Europe.

Industry sponsor provides funding for development of database in a particular disease or technological area. Sponsor has one-year exclusivity to the data for the specific disease, for which funding is provided.

Project will be executed in two phases:

  • First phase: development of database with all relevant data sources and publications. The client will have access to the data during the development phase.
  • Second phase: maintenance with monthly update of the database with inclusion of new publications

The total output of the project will include publications about available RWE in a specific disease area. 

The company sponsor will get a unique opportunity to establish an overview of the data that can inform them how to best apply the use of real world evidence in the future for a marginal additional cost of being the selected industry partner.