Comparators
Comparators are used in clinical trials to compare the success of a medicine under study to another medicine or placebo. In Calyx RIM, comparators are treated as separate entities that are not part of any existing Calyx RIM hierarchy. As separate entities, comparators can be created and managed from the Comparators tab, accessible from the Home page.
Comparators can only be applied to Clinical Trial Authorization (CTA) and Investigational New Drug (IND) applications. For these applications, comparators are further defined by product type. You can designate the comparator entity as a placebo, Investigational Medicinal Product (IMP), or a comparator that is an existing product. Additional comparator product types can be created in Data Administration, if needed.
The following table differentiates the default comparator product types.
| Product Type | Description |
|---|---|
| Comparator | A marketed product that contains an active ingredient. A comparator can be a competitor's product or a internal product. In Calyx RIM, an internal product is considered a comparator if it is not included in the product family to which the product under study is associated. |
| IMP | A medicinal product under investigation that contains an active ingredient. In Calyx RIM, any product associated with the product family to which the product under study is associated is considered an IMP. You do not need to set IMP as the product type. Use the IMP product type to identify a product outside of the product family. |
| Placebo | A comparator that does not contain an active ingredient. |
When you create a comparator entity, you have the option to assign an active ingredient. Selecting an active ingredient is not required, even if you are creating a product type of comparator or IMP. The available active ingredients listed are those that your data administrator has added to the system.
You also have the option of assigning suppliers to comparators, which lists active manufacturers in Data Administration.