Quarterly Canadian Cancer Trials Group Line Listings (Summary) of Safety Updates
|The distribution of safety reports to centres as a summary of events rather than as individual reports has been discussed in recent years by the International Conference on Harmonization (ICH) resulting in the creation of a number of guidance documents to address the issue and outline acceptable procedures. The FDA and the European Union, as well as some pharmaceutical companies, have adopted these procedures. Health Canada follows ICH guidelines. This new method of safety report distribution seeks to alleviate concerns from centres and REBs over the volume and frequency of individual reports received from sponsors while ensuring that relevant and meaningful information is provided. Over the past year, Canadian Cancer Trials Group has been piloting this distribution method. Some pharmaceutical companies have also begun to issue such summaries.
Beginning in July, Canadian Cancer Trials Group will begin to distribute summaries for safety updates (safety reports which occur on non-Canadian Cancer Trials Group trials) for most of the agents being used in Canadian Cancer Trials Group trials for which a CTA is held. You can expect to receive them in July, October, January and April. These reports will be a listing of events that have been sent to this office during the previous three month period, assessed by our in-house physicians, and determined to be serious, unexpected and possibly, probably or definitely related to the agent, and therefore requires distribution to centres as part of the Summary. The events included in the Summary will not require changes to either the protocol or the informed consent document as reports requiring change to these documents will have been sent to centres individually in real time. The method of notification via email and posting to the web-based safety monitoring utility for each trial will be the same as for other safety reports distributed in the past.
It is expected that the Summary be submitted to the REB within 30 days of the date of the notification and that the appropriate date of REB submission be entered into the web-based utility by the designated ECRA or PCRA for the trial, as is the current standard practice for all safety reports received from Canadian Cancer Trials Group. Individual reports for these events will not be provided.
The following types of events will continue to be distributed to centres, as individual reports, as they become available:
-- Serious adverse events that occur on Canadian Cancer Trials Group trials that are deemed to be serious, unexpected and at least possibly related to drug; and,
-- Safety updates that are assessed by the Canadian Cancer Trials Group physicians to be regulatory reportable and to require immediate distribution due to the importance of the information contained within OR will result in a protocol or informed consent document change.
Questions can be directed to the study coordinator for your trial.