model Clinical Trials Agreement (mCTA)

mCTA adoption and implementation update

Between September 26 and October 25, 2017, the CCTCC and members of the mCTA working group met with key stakeholders of both sponsors and sites to discuss the adoption and implementation of the mCTA. Three meetings were held in Toronto, Montréal and Calgary. The goal of the meetings was increase awareness and understanding of the mCTA, as well as discuss implementation and adoption. The WG leads were available to answer questions that the participants had regarding the development of the contract and indicated that they would also be available after the meetings to answer questions regarding language choices and barriers to adoption.

The discussion at each meeting was focused on adoption and implementation. Specifically, with respect to adoption the questions that were asked are: Who is committed at this point and how do we overcome the challenges and move towards adoption? The second discussion regarding implementation was a practical discussion of what systems and tools needed to be in place to ensure success.

Two of the key things that both sites and sponsors indicated were:

  1. The importance of increasing awareness of the mCTA which can be achieved through education including presentations at conferences or other meetings as requested by users of the mCTA. In addition, there needs to be a top down approach developed for key stakeholder groups such as IMC and HealthCareCAN.
  2. Having a publicly available list of sites and sponsors who are committed to using the mCTA.

In addition, there were several topics that were key to the discussion and which feature in the next steps for this initiative. These include the barriers to adoption, the development of an administrative tool to collect feedback and use metrics, as well as the promotion of adoption to stakeholders and the development of a system for annual input into the mCTA. This discussion was considered when developing the next steps.

 Next Steps

  1. Q&A sessions regarding the process/language of version 8:
    1. The CCTCC will host 2 teleconferences on January 11, 2017 which will provide the opportunity for sites and sponsors to separately ask their questions regarding the development of the contract language and how feedback was incorporated.
      1. January 11, 2018 @ 10:00 am EST – Teleconference for Sponsors
      2. January 11, 2018 @ 1:00 pm EST – Teleconference for Sites
    2. We request that you R.S.VP. for the sessions by January 5th, 2017 to mcta@cctcc.ca.  To facilitate the discussion, we also request that you submit your initial questions by the same date also to mcta@cctcc.ca
  2. Feedback and Metrics Collection
    1. To ensure the continued relevance of the mCTA the CCTCC seeks to collect feedback and metrics on it’s usage. The metrics we are proposing to collect are detailed in the attached excel document. While the system for collection metrics is being developed we strongly encourage everyone to use the template as is and to provide any feedback they might have. We are also working on establishing a governance model which will ensure the continued relevance of the mCTA. This would include yearly input and review of the contract language for any necessary changes. For more information please see the FAQs below. 
  3. Adopters
    1. A list of mCTA adopters is being developed. It will be posted on the CCTCC website and updated as new organizations are added. A draft letter detailing the commitment of adopters is available here. The CCTCC will finalize the letter and confirm details regarding the governance of changes and updates to the mCTA in early 2018. If you have any feedback or questions regarding the commitment of adopters please contact us.

 

mCTA Version 8:

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

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.

Frequently Asked Questions

How can we ensure that at the institution and pharma level that everyone who deal with contracts are aware of and aligned on the use of the mCTA?

Communication and dissemination of information to ensure that everyone is on board. Informational tools and an executive summary will be developed to ensure both sites and sponsors feel equipped and comfortable discussing and using the mCTA.

What is the risk associated with the mCTA?

There is a risk associated with not adopting this – from the perspective of attracting trials. We just can’t compete on an international level, which is necessary to ensure we can attract trials.  Ensuring the sustainability of clinical trials in Canada. If anyone sees a potential risk, contact the CCTCC and we would be happy to discuss. 

What does it mean to agree to be an adopter of the mCTA?

See letter above

What happens when a CRO is involved? Are they being consulted in the adoption process?

Most sponsors indicated that their CROs use the contract as provided to them. However, this may be an area that requires further investigation to ensure proper understanding. This could be as simple as providing CROs and sponsors with educational tools to increase their understanding and awareness of the mCTA and its purpose.