ACAHO, Rx&D and CIHR announce pilot of first ever standardized model Clinical Trial Agreement
For the first time in Canada, a model Clinical Trial Template Agreement (mCTA) has been proposed for pilot purposes in negotiating regular (non exceptional) Phase II and Phase III single and multisite clinical trial agreements between sponsors, clinical sites, and principle investigators (http://www.cihr-irsc.gc.ca/e/44203.html). The template, developed by representatives from ACAHO and Canada's Research-Based Pharmaceutical Companies (Rx&D) and with support from the Canadian Institutes of Health Research (CIHR), is a direct response to calls from the field for such a resource and we are delighted to provide this draft for pilot test purposes.
Over the past 4 years, there has been growing concern that the number of clinical trials in Canada is decreasing due to operational barriers and internationally competitive efforts in other parts of the world. The release of the mCTA will help simplify and expedite the start-up times for clinical trials in Canada. Doing so will bring us one step closer towards increasing the attractiveness of Canadian clinical trial sites as preferred partners internationally for clinical trials, and ultimately continue to bring human, social and economic benefits to all.
While a pilot will be used to improve the draft mCTA, the Canadian Institutes of Health Research (CIHR), ACAHO and Rx&D would like to acknowledge the members representing each of ACAHO and Rx&D who have worked together on drafting the mCTA for pilot purposes. They have dedicated an incredible amount of time, expertise and goodwill in proposing a template that we all believe will be an excellent starting point.
As next steps, a pilot project will take place from October 1, 2011, to March 31, 2012. During this period, all members of ACAHO and Rx&D will be asked to use this template as the basis of clinical trial agreement negotiations. Participants may modify the mCTA for the purposes of the actual agreement that is signed, however, participants are asked to note changes and forward these to CIHR using forms that will be provided (http://www.cihr-irsc.gc.ca/e/44186.html). This will allow for an objective assessment of whatever elements of the template need to be changed in order to accommodate the needs and interests of all parties.
September 15, 2011