The Canadian Cardiac Chronicle Volume 18, No. 1
Spring 2014
Sometimes you just need to talk to people. So we did just that on Sunday, March 9th during a CVC sponsored clinical research colloquium held in Banff, Alberta in conjunction with the annual ACC Rockies Meeting. For some time we have been reflecting on the challenges facing our valued clinical research partners across Canada as it relates to continued participation in clinical trials. Last autumn we finally decided it was time to do some direct listening and learning. The concept was simple, namely to foster an open communication between our own academic research organization (CVC) and key community practicing site principal investigators and site coordinators. The aim was to generate productive dialogue that resulted in identification of key issues that restrict clinical trial involvement in Canada and develop strategies to overcome them. Once this concept was hatched and Tracy Temple agreed to organize it, I knew we were on the right track! We were fortunate to be able to generate both enthusiasm and unrestricted educational grant support from Amgen, Astra Zeneca, Merck and Sanofi-aventis that allowed us to hold the event this past month. We had an ambitious set of goals i] review major impediments to timely/efficient participation in clinical trials at the site level, ii] identify common issues that can be addressed collectively, iii] understand how best to add value to clinical trial experience at site level, iv] enhance our network of high performing sites (quality/quantity) and V] explore the potential for more common standard operating procedures (SOPs) in order to enhance Canada’s position in CV trials/ research. Because we reckoned there were differing trial “cultures” and correspondingly different needs for acute trials (e.g. acute coronary syndromes and heart failure) versus those involving secondary prevention (e.g. post ACS, diabetes and dyslipidemia) we decided to invite a spectrum of colleagues that represented those areas of research and also our geographic diversity. The CVC is proud to be a University of Alberta Centre
In This issue: Letter - P.W. Armstrong Trial Updates Monitoring CVC News CVC Publications
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Key members of the CVC clinical trials coordinating team participated in this half day interactive session with both academic and community site principal investigators and coordinators in the presence of industrial medical representatives. All participants were required to complete a pre-meeting web-based survey that identified catalysts and barriers to the conduct of clinical trials in Canada. In conjunction with key, selected and brief presentations; the survey results were collated and presented at the half day interactive session. There was ample time for vigorous and open discussion and we committed to summarizing the discussion in a white paper that will accompany the next edition of the Chronicle. Although a formal evaluation is still in progress, the immediate feedback from both our invitees and sponsors was enthusiastically positive about the event. Specific action items emerged aimed at accelerating trial “startup times”, avoiding duplication and rationalizing SUSAR reporting. Each invitee is about to receive the overall survey result as well to be able to reflect on their views in this context. We look forward to sharing more learnings from this informative and rewarding networking event and engaging our other valued collaborators in the future. Stay tuned… With kind regards,
Paul W. Armstrong