Data characterization of population-based data sources: ConcePTION pipeline

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107620
• EU PAS number:
  EUPAS50142
• Study ID:
  107620
• Official title and acronym:
  Data characterization of population-based data sources: ConcePTION pipeline
• DARWIN EU® study:
  No
• Study countries:
  Finland

  France

  Italy

  Norway

  Spain

  United Kingdom
• Study description:
  The use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision making is increasing (https://rwe-navigator.eu/use-real-world-evidence/sources-of-real-world-data/). In order to make best use of RWD many data sources in a scalable rapid and reproducible manner, many groups and consortia have turned to the use of common data models (CDMs). This approach aims to transform data from different databases into a common format (i.e data model). This data can then be analyzed using scripts written based on that common data format. In this study, we will develop the pipeline of three-levels quality checks for the ConcePTION CDM which include the evaluation of the Extract-Transform-Load (ETL) process, quantify the completeness of the databases, and assessment of counts and distributions of variables and dates. The characterization study will be based on at least 12 data sources, covering at least 6 European countries: France, Finland, Norway, Italy, UK, and Spain (approx. 36.2 million individuals). After each check an html report visualizing the results will be produced. In the final study report, incidence rates from literature will be presented together with incidence rates estimated for the current study. Discrepancies will be identified and interpreted based upon descriptions of the data source(s), algorithms for identification of events, and design choices including inclusion and exclusion criteria in published studies vs. those employed for this protocol. The output of this study will be a series of scripts openly available on an online repository. All the quality checks reports will undergo through an approval process assessed by the conception quality check advisor and the data access provider representative.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University Medical Center Utrecht (UMCU)

Netherlands

Julius Center

Networks

ConcepTION

Study timelines

Date when funding contract was signed

Actual: 01/04/2019

Study start date

Actual: 08/05/2021

Data analysis start date

Planned: 01/02/2023

Date of final study report

Planned: 31/01/2024

Sources of funding

EU institutional research programme

More details on funding

IMI ConcePTION

Study protocol

Initial protocol

ConcePTION Data Characterization Indicators_populationbased_V1.1_08NOV2019 (2)

Updated protocol

ConcePTION Data Characterization Indicators_populationbased_Revised_13Nov2023

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable