model Clinical Trials Agreement (mCTA)

Update: 

mCTA Version 8 is now offered to everyone interested in being an early adopter.

The early adopters will be asked to use the mCTA and provide the following information regarding their experience using the mCTA:

  • Time from contract ideation to execution/ speed of contract negotiation
  • Suggested amendments for the periodic review of the mCTA, especially if there is language that posed significant challenges
  • How does the experience negotiating with the mCTA compare to their regular negotiating practices 

A series of webinars and face-to-face meetings with interested early adopters are available upon request. 

If you are interested in becoming an early mCTA adopter or have any questions, please email: mcta@cctcc.ca

Click below to access the:

 

Background:

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.

History:

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 launched a consultation of the mCTA language and CLEAR Clauses. The CLEAR Clauses (a TransCelerate-supported project) reflect international discussions on the controversial elements of the mCTA. Our goal was to integrate the CLEAR clauses (whenever possible) and the mCTA to make it more feasible for use. 

The goal of this consultation was twofold, to:

  • determine the acceptability of the revised mCTA in general, and

  • provide feedback from Canadian sites and sponsors to the CLEAR initiative 

As an immediate next step, the CCTCC in collaboration with Innovative Medicines Canada organized a series of mCTA open house sessions, during the second half of 2016, for pharmaceutical companies staff involved in contract negotiation. The goal of these sessions was to:

  • educate the pharmaceutical companies about the CLEAR initiative which will be coming to the Canadian offices of TransCelerate-member companies, and

  • gauge their engagement and buy-in of the mCTA.

Following the resolution of the received feedback, the mCTA was reviewed by an independent legal counsel for the purposes of ensuring consistency of terminology use and definitions, and clarifying ambiguous wording.