7. Improve and use the common clinical trials contract:
The model Clinical Trial Agreement (mCTA)
The model Clinical Trial Agreement (mCTA) provides a standard model contract for use by clinical trial sites and sponsors in negotiating phase II and phase III clinical trial agreements. The contract is a response to shared concerns that completing contract negotiations, particularly where the same company is involved with sites in multiple provinces and a master agreement is not in place, complicates the process of bringing clinical trials to patients and puts Canada at a disadvantage globally. The mCTA is a direct response to recommendations from the field for a standard clinical trial template agreement that can help to streamline the negotiating process and expedite clinical trial start up times.
In the past, a model clinical trials agreement (mCTA) pilot which took place in the field revealed a number of challenges. Click here to learn more about the history of the mCTA.
To address these challenges, the CCTCC core mCTA Working Group with help from Innovative Medicines Canada and their member companies, HealthCareCAN and many provincial clinical trial bodies reviewed the mCTA text. Since many of the innovative pharmaceutical companies (also Innovative Medicines Canada members) are participating in an International TransCelerate (CLEAR – Common Language Evaluation and Reconciliation) initiative to address five controversial clauses within clinical trial contracts, the CLEAR clauses were provided for review as well. Click here to learn more about these current developments.
On October 29th, 2015, representatives from clinical trials sites, provincial clinical trial bodies, N2 and Innovative Medicines Canada members known as “Team Canada”, met to review the TransCelerate Clauses and provincial feedback.
As a result of this meeting, CCTCC is pleased to launch a final review of the mCTA language and CLEAR Clauses. The CLEAR Clauses reflect international discussions on the controversial elements of the mCTA. Our proposal is to integrate the CLEAR clauses (whenever possible) and the mCTA to make it more feasible for use. Your feedback is welcomed on both the mCTA and the CLEAR clauses. Feedback on the CLEAR clauses will be communicated to the CLEAR international steering committee. Feedback on the mCTA will be considered in next steps.
Please use the full review package to provide your feedback.
The review package inlcudes:
The deadline for proving your feedback is February 28, 2016. If you have any questions about this consultation, please contact Elena Aminkova.
We are thankful to all individuals and organizations who invested their time and efforts in advancing this project this far.