Linking Clinical Trial Data with ICES Data
The ICES data repository consists of record-level, de-sensitized and linkable data sets. It encompasses many of the publicly funded administrative health services records for the Ontario population eligible for universal health coverage since 1986, and it is capable of integrating research-specific data, registries and surveys. The repository includes health service records for as many as 14 million people.
Administrative data such as that in the ICES data repository can be used in clinical trials. In some cases, administrative data may be a substitute for bespoke data collection during the trial. In addition, administrative data can be used to assess long-term outcomes after the trial period ends (for example, the “WOSCOPS 20 Year Follow-Up Study”). Currently, work is underway to compare and validate cardiac outcomes when measured prospectively in clinical trials with the same outcomes determined using administrative data.
To transfer clinical trial data to ICES for linkage, study investigators require the following:
A research ethics board (REB) approved research plan which states explicitly the intent to transfer the trial data to ICES for linkage.
Although patient consent is not legally required for ICES to receive the trial data, REBs may require that consent be obtained to disclose the data to a third party such as ICES for linkage. See suggested consent text below.
Before the trial data (full or subset) is transferred to ICES, an agreement between the principal investigator and ICES that governs the sharing of data must be established.
Suggested Text to Include in an Informed Consent Form
Under “Description of the Research”
ICES data linkage: We also require your permission to collect information on your clinical outcomes (e.g., hospitalizations, receipt of services such as dialysis, death). This will be done by linking information like your health card number and name to healthcare databases held at the Institute for Clinical Evaluative Sciences (ICES). The ICES databases contain information about physician, hospital, home care services and medications that are paid for by the Ontario government. The linkage of your data with ICES databases will be done in order to [list the purpose of data linkage, for e.g., to evaluate the efficacy of the intervention, and/or assess its long-term outcomes].
Information like your health card number and name will be securely transferred from [list hospital, clinic, etc. where research is taking place] by or on behalf of the study investigators to the Institute for Clinical Evaluative Sciences (ICES) so the required linkages can be made to gather the information for the study. The study investigators will be permitted to access de-sensitized information only for analysis (i.e., any information that can directly identify a person like health card number or name will be removed or replaced with a code that is not known to the study investigators).