Negotiating individual clinical trial agreements between sponsors and researchers can be a time consuming process. The Model Clinical Trial Agreement (mCTA) project is aimed at reducing the startup time at clinical trial sites by providing an agreed upon template which can be used to begin negotiations. Upwards of 75% of the content of agreements are identical, and a further 10% is easy to harmonize. The remaining issues can be resolved more easily if the first 85% are already agreed upon.
The mCTA was created, reviewed by a pan-Canadian, cross-domain committee, and was then piloted at multiple sites across Canada. A further review for input and endorsement was conducted at the provincial level. The pharmaceutical industry was involved in the initial creation of the mCTA and is now being engaged to provide further input and endorsement of the current version. Once this portion of the review is completed, a penultimate version of the mCTA will be widely distributed and publicly available.