BCCRIN Research Contracts Task Force Objectives

Objective

Details

Timeline

Resources

Measuring Success

  1. Develop a memorandum of understanding between the main research intensive institutions and UBC, leading to harmonization of the negotiation and acceptance of a research contracts for industry sponsored clinical trials.
  • Draft MOU outlining agreement for contracts review and approval across signing parties.
  • Review CAHO “Statement of Principles to be Considered when Negotiating a Clinical Studies Agreement” document.  Adopt best practices as applicable to BC and attach to MOU.
  • Aim for stepwise adoption across province.

Complete

 

 

 

Dec 2011

Time

  • MOU signed by 6 research intensive institutions in BC.
  1. Identify the issues and challenges affecting the clinical research contracts negotiation and acceptance process in BC.
  • Conduct a meeting with industry stakeholders to open a dialogue on challenges and engage participants in solutions process.

Complete

Time

  • Meeting participation by 50% of invitees.
  • 3 concrete next actions stemming from meeting.

 

  1. Develop a key performance metrics system to track key performance indicators related to clinical trials.
  • Assess common metrics and select most meaningful ones for BCCRIN partners.  Set realistic targets and measure performance.  Address and remove roadblocks.
  • Identify and acquire / develop a system for tracking metrics, e.g. Access database (UBC), RiSE system, CTMS.

2012

 

 

Task Force

  • Ability to measure and report on key performance indicators.
  • Streamlining of processes leading to more efficient study start up activities.
  1. Increase the business acumen of clinical trials site personnel to foster more accurate feasibility assessment of clinical trial opportunities and corresponding budget development.
  • Identify and assess existing training programs or procure development of new program, collaborating with pharma partners, if appropriate.
  • Identify or develop financial management and budgeting modules.

Complete but continuing

Task Force+

  • Training program that meets the needs of BCCRIN constituents; is affordable, accessible and relevant.
  1. Streamline study start up costs across the signing parties to the MOU.
  • Develop and implement a survey on 10 fees common to most clinical trials.
  • Review results to determine how consistent (or not) institutions are with respect to pricing.
  • Seek to streamline costs, as appropriate with a goal of becoming more predictable on pricing while adequately recovering costs.  Work with HSSBC where relevant.

2012

Consultant or co-op student.

  • Consistent, transparent pricing policy across MOU parties.
  • Increase in business to BC from pharma partners.
  1. Represent the interests of BC at national level initiatives, e.g. CIHR ACAHO, Rx&D, Industry Canada
  • Yvonne Lefebvre (ACAHO rep)
  • Rob McMaster – Clinical Trials Summit Steering Committee member

Ongoing

Task Force