The need for FMV WG:
The CCTCC is actively working on addressing the critical bottlenecks that delay the initiation of clinical trials (CT) in Canada. The contracting process was identified as an important bottleneck and the Model Clinical Trial Agreement (mCTA) project is attempting to address this issue. There has been significant progress made on the mCTA and we hope to have a final document in place later this year.
However, during the consultations on the mCTA there was consistent feedback that we would not see the maximal benefits from streamlining the clinical trial agreement process until the challenges with the budgetary negotiation process are addressed.
Industry Sponsors are required to ensure that all financial transactions with investigators including those related to study budgets are consistent with FMV. Calculating FMV is not an easy task and negotiations related to establishing FMV can lead to substantial delays in getting agreement on a study budget. Sponsors that elect to disregard FMV regulations (such as the US Federal regulations) can be subject to harsh penalties. The investigators are also at risk if they receive payments above FMV as this could be seen as an inducement. Therefore, it is very important that FMV be developed using a consistent methodology, be transparent, defensible, and documented.
Establish a FMV WG to develop an independent and sustainable process for determining FMV that takes into account the cost differences across different provinces and different institutions within a province. The process will, then, be used to develop an online tool for calculating FMV. This tool will take into account the cost differences across provinces, cities and institutions.
Develop a tool for determining FMV which will provide pricing information for all CT medical procedures and activities while taking into consideration the price differences across provinces and across institutions within a province.
Streamlining the budgetary negotiation process will speed up CTs start-up times and enable Canada to compete adequately on the global CT stage. It will also allow us to maximize the benefits received from implementing the mCTA.
Form a Working Group (WG) with a lead representing industry and a co-lead representing the research institutions. The WG will be tasked with:
- developing a sustainable process for determining independently FMV for the common line items in CT budgets
- helping develop an RFP for selecting an external vendor to implement an FMV determination tool that follows the process.
Organizations and individuals interested in nominating WG members are invited to submit nominations to email@example.com by March 17, 2016. For more information, please contact Elena Aminkova, CCTCC Interim Director of Project Facilitation at firstname.lastname@example.org or (613) 233-5678.