Clinical trial contract negotiations can take as much as 9 months to a year to complete. There are two separate but related and converging efforts going on in Canada and internationally to reduce negotiation times for clinical trials. The CCTCC
plans to integrate these initiatives to take the next step towards streamlining clinical trial agreements in Canada.
Firstly, the model Clinical Trials Agreement (mCTA) which was originally negotiated by members of Rx&D
through the resources of the Canadian Institutes of Health Research (CIHR)
and using the “CAHO principles”
or contract best practices.
Secondly, the TransCelerate
CLEAR (Common Language Evaluation and Reconciliation) Initiative; an industry membership driven organization conducting a North American initiative to identify text that could reduce negotiation times for the five of the most contentious clauses including Subject Injury, Indemnification, Intellectual Property, Publication and Confidentiality.
Currently, it is proposed that representatives of TransCelerate
, the provincial bodies, and the Canadian Clinical Trials Coordinating Centre (CCTCC)
work together to advance the potential of a common contract through the development of a pragmatic, online contracting tool that would help reduce the amount of time spent on the negotiation of clinical trial agreements and improve clinical trial start-up times in Canada. The way this will be done is as follows:
The model clinical trials agreement will be reconceptualised into two groups of clauses: (1) clauses that are currently on the TransCelerate
agenda (contentious clauses) and (2) clauses that are not currently on the TransCelerate
agenda (non-contentious clauses). For the contentious clauses on the TransCelerate CLEAR initiative agenda, a Canadian contingent composed of representatives from Rx&D
, and provincial bodies will work in parallel to the CLEAR project. Feedback from the Canadian contingent will be brought back to the table for CLEAR consideration and inclusion to ensure the developed language will work in Canada. This will ensure a Canadian site perspective is offered efficiently in the development of the text for the contentious clauses previously identified. For the remainder of the clauses in the mCTA, Rx&D
members will review the comments and preferences expressed by the provincial bodies and sites and will come back with an offer for consideration by the sites. Where there is acceptability, these clauses will be entered into the online contracting tool. This web tool will incorporate provincial differences and TransCelerate
clauses as they are produced. A communication and education strategy will be developed in conjunction for Rx&D
member companies and HealthcareCAN
members which will include a change in name for the new tool - moving away from a model clinical trial agreement, and closer to a pragmatic online contract tool.
The pilot phase of this webtool will be ready for launch in December 2015 and will be housed on the CCTCC