Canadian Cancer Trials Group Bulletins

General


Permanent Study Closure

As you are aware, the need for continued follow-up and ethics approval for trials where data is no longer required nor utilized poses a significant burden on both participating centres and Central Office staff. Therefore, the Canadian Cancer Trials Group has recently undertaken a process to systematically evaluate our trials in order to determine whether continuation of trial activity is warranted. This includes the discontinuation of protocol-required follow-up data submission for some trials after taking into account all scientific, logistical and administrative considerations.

We have completed part I of this process for phase I/II/III Canadian Cancer Trials Group-led trials (note: a similar review of all closed IND trials has already been undertaken and review of Intergroup-led trials is underway). The trials that have been identified in this initial stage of the process have long since closed to accrual, completed final analysis and been published (in most cases).

Following is a link to a memo from Dr. Meyer sent on Wednesday, December 17 to participating centres, Disease Site Chairs, pharmaceutical company partners, Intergroup collaborators, and regulators, as applicable:

http://www.ctg.queensu.ca/trials/2008-FinalLettertoCanadiansites-1.pdf

This memo elaborates on the process undertaken by Central Office and includes a list of those trials for which data submission and REB approval are no longer required.

If you have any questions about this, please contact Anna Sadura at asadura@ctg.queensu.ca.