CCDD and scope for Investigational Agents (Medications)

Hi
thankyou Monica for raising the question and for your additional comments Ray.

I have confirmed with Health Canada resources how investigational products are dealt with and when they would make it to the CCDD.
• After clinical trials are complete the product is submitted for Health Canada approval
• Once approved the product is published in the Drug Product Database (DPD).
• When the drug manufacturer informs Health Canada that the product is offered for sale (marketed) in Canada, and if it falls within the CCDD scope and it is then added to the CCDD. There is no change to the CCDD if a marketed product is part of a clinical trial.

I hope that addresses your questions and comments.
thankyou
Beverly and CCDD team

As a primary care physician I have had patients that have been on investigational medications. What will be the recommendation on how to record these things. If these are deemed to be out of scope they I suppose I will have to enter them as free text.

All I would expect is to have a name that can be used for recording and communicating. It would not really matter if it is not 'fully defined'. I think having something would be better than having nothing.


Ray Simkus

Hi there:

In the latest powerpoint presentation on what is in/out of scope for the CCDD, investigational agents are considered as out of scope. I agree that agents tested in phase 1 clinical trials for now can be considered out of scope. At a certain stage an investigational agent might already have a DIN assigned. If so do we still want this agent to be "out of scope" ?