Cohorts
One of the pillars of the partnership is the structuring of ambitious cohorts designed not only for their scientific relevance, but also with the objective of building a foundation for the partnership, giving a competitive advantage to our partners. These cohorts are designed in such a way as to anticipate translational research, the development of IT solutions (including in AI) to assist in diagnosis and to be able to be reused (samples and data) in the context of subsequent partnerships. ICAN develops a range of qualified and annotated data with high added value, strengthening the attractiveness of our research teams at the international level. The combined access to the large cohorts and to the technological platforms of the ICAN constitutes a breeding ground for companies wishing to establish the proof of concept of their solutions.
The research carried out in France on cardiometabolism is numerous but sometimes scattered. The cohort plan is one of the strategic actions of the IHU-ICAN. Its objective is to develop translational and interdisciplinary research as well as academic and industrial partnerships.
The cohorts therefore constitute a major pillar of the research carried out by the doctors and researchers of the IHU-ICAN. A call for expressions of interest was made in 2017 in order to initiate substantive work around the cohorts. Many clinicians have responded to this call, and around fifty projects have been identified, opening up the possibility of using clinical data from several tens of thousands of patients.
But what is a cohort?
A cohort brings together subjects sharing together a certain number of characteristics (medical, biological, etc.) followed over time (a few months or years) in order to carry out a scientific study. These cohorts are then used by the investigators as a reference for their various studies.
The word “cohort” can be defined in 3 different ways:
- The cohort study : consists of following a defined population for a given time and gradually collecting a lot of information and the events that have occurred during this monitoring period (diseases, changes in habits, etc.)
- A patient registry : it is a registry for the continuous and exhaustive collection of health data in a geographically defined population for research and public health purposes.
- A biological collection : it is the combination of different biological samples taken from a group of people identified and selected according to their clinical and biological characteristics.
To be valuable, these cohorts must meet strict criteria in terms of regulatory compliance and data quality.
The IHU-ICAN has therefore implemented a 3-step strategy
1 - Collection of needs and design of the database
- Validation of the needs expressed by the investigators during an IHU COMEX
- Creation of the “data-dictionary” of the final database, from the various files provided by the investigators
- Creation of the e-CRF with standardization of variable names whenever possible
2 - Data management of the existing
- Mapping and cleaning of data from existing databases, with identification of errors to be corrected and proposal for correction in conjunction with clinicians.
- Creation and formatting of files to import (naming of variables, coding of variables, repeatable variables, etc.)
3 - Release
- Import of the empty database carried out under the responsibility of ICAN
- REDCap settings (study design / repeatable)
- Importing data into the AP-HP database in production.
Since the cohorts use personal data, regulatory support has been put in place whenever necessary. Procedures which govern the processing of personal data for purposes of study, evaluation or research not involving the human person, have enabled the establishment of a legal framework and a common framework has been created with the AP-HP in order to facilitate and accelerate submissions to the Sorbonne University research ethics committee.
The support of the IHU-ICAN focused mainly on the time of the staff dedicated to this plan: 2 data managers and 1 third-time project manager, to which is added the support by the legal and valuation pole, as well as the investment of the URC project manager dedicated to ICAN.
The methodological support and scientific expertise from which the IHU has been able to benefit throughout the 3 years has made it possible to strengthen the links between ICAN and the ecosystem dedicated to research. Today, the ICAN is an expert in the issues of implementing the AP-HP’s REDCap, and is one of the recognized interlocutors.
