Alert generation using the case-population approach in the French claims databases (ALCAPONE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49951
• EU PAS number:
  EUPAS13031
• Study ID:
  49951
• Official title and acronym:
  Alert generation using the case-population approach in the French claims databases (ALCAPONE)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  ALCAPONE aims to assess the suitability of the French nationwide healthcare insurance system database (SNIIRAM and EGB) for drug safety signal generation based on the OMOP reference set and methodologies, and the case-population approach. Once the initial calibration is completed, methods will be tested on incident alerts and suspected drugs.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Contact details

Nicolas Thurin

Study contact

[e-mail]

Nicholas Moore

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 28/12/2014

Actual: 28/12/2014

Data collection

Planned: 02/10/2017

Actual: 02/10/2017

Start date of data analysis

Planned: 01/11/2017

Date of interim report, if expected

Actual: 18/08/2017

Date of final study report

Planned: 31/12/2019

Actual: 31/10/2019

Sources of funding

Other

More details on funding

Direction Générale de l’Offre de Soins (DGOS)

Study protocol

Initial protocol

ALCAPONE-protocol-v1.1-20160405

Updated protocol

ALCAPONE-protocol-v1.2-20160405

Regulatory

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