Study identification

EU PAS number

EUPAS1000000207

Study ID

1000000207

Official title and acronym

Shortening the time to confirm or to rebut Adverse events of interest related to innovative Therapies for immune-mediated inflammATory dIseases: cross-talking between different data sOURces. SATURATIOn study.

DARWIN EU® study

No

Study countries

France

Study description

To identify or to rebut adverse events of interest (AEs) is a challenging aim. Twenty years after the introduction of Tumor necrosis factors inhibitors (TNFi) for immune-mediated inflammatory diseases (IMIDs), the association between AEs and TNFi according to the underlying pathology is still not clear. Currently, several databases relying on different recording methods are used in pharmacoepidemiology to detect AEs. Jointly analyzing these different data sources (integrative approach) is often discussed as a way to improve the detection of AEs. However, synthesizing all these replicative results is highly time-consuming and requires a heavy workload, thus leading to delayed conclusions. The French National Health Data System (SNDS) has been used in France to conduct real-life studies on large, unbiased and nationally representative samples, especially regarding the safety of drugs. Our hypothesis is that assessing AEs related to biologics through the SNDS would yield earlier as reliable results as those obtained through an integrative approach. The aim of SATURATIOn is to shorten the time to confirm or to rebut adverse events of interest associated with innovative therapies for IMIDs by using SNDS data. To achieve this objective we propose a 4-year program comprising 3 Work Packages. In WP1, we will use an integrative approach in order to identify AEs related to biologics/target therapies (systematic reviews and network meta-analyses based on trials and observational studies); ii) in WP2, we will identify the same AEs related to the same therapies using SNDS data; machine learning will be used to improve high-dimensional proxy confounder adjustment ; iii) In WP3, we will compare the results from the integrative approach and from the French health-insurance data regarding AEs. Overall, the main interest of the SATURATIOn phamacoepidemiological project is to allow the fast generation of appropriate analyses for confirming the occurrence of biologics-related AES.

Study status

Planned
Research institutions and networks

Institutions

University Paris Est Créteil

Networks

Contact details

Emilie Sbidian 0000-0002-1267-5270

Primary lead investigator
ORCID number:
0000-0002-1267-5270
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Other public funding (e.g. hospital or university)

More details on funding

- We obtained funding from the National Agency for Safety of Medicines and Health products to conduct a three-year PhD program (November 2023) to conduct the WP2
- We obtained funding from the Univeristy Paris Est Créteil to conduct a three-year PhD program (November 2023) to conduct the WP2
- WP1 will be conducted by the permanent researchers of the team
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable