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 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 is 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 are organizing a series of mCTA open house sessions for pharmaceutical companies staff involved in contract negotiation. The goal of these sessions is 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.
A detailed consultation report including the outcomes from the open houses and an annotated copy of the most updated copy of the mCTA will be made available shortly to all stakeholders, once the open houses are completed.