Canadian Association for Independent Clinical Research
L'association Canadienne pour la recherche clinique independante
As of November 2014, there is a Canadian Standard for Research Ethics Oversight of Biomedical Clinical Trials. Jack was on the committee as a voting member for the entire 4 year process! He is an expert and will discuss how this is being implemented and how the uptake is coming along! Please join us to be up to date on this key Canadian topic!!
1. Explain what official federal government Standards mean, and the singular process by which they are set
2. Review the long-standing regulatory pressures to establish an accreditation system for REBs in Canada, given the lack of authority of the Inspectorate over REBs
3. Discuss the essential elements of the standard and its implications for REBs reviewing regulated clinical trials in the future
Speaker: Jack Corman, CAICR President
I. Call to order
Jack Corman called the meeting to order at 5:10.
II. Roll call
Jack Corman, Stephen Garland, Ronald Fehst, Graham Wood, Karri Venn,
Joanne Mabee, Gail Somer,
Guests: Elena Aminkova, Dr. Greg Koski(unable to attend)
By Conference Call
Carla Cockerline , Renzo DiCarlo, Ingrid Holmes, Guy Tellier , Pierre Gervais, Mario Tanguay, Najla Guthrie; Avril Norton; I. Dan Dattani; Shawn Keown;
Representatives from CCTAM and ACRES were invited to attend the meeting.
Unfortunately Greg Koski was not able to attend via web session.
Jack Corman welcomed everyone and the guests, and presented an opening progress report of the activities CAICR has been actively participating in this last year. Jack noted that CAICR has worked closely with CTO,BCCRIN and CCTCC to reinforce the major role played by private sector in clinical trials within Canada.
Jack mentioned that CAICR members have been invited as speakers to several meetings over the last year, including an invitation to Dr. Aronson to speak at the upcoming CTO conference in March 2015.Members are also active on CTO and CCTAM working groups.
Jack noted that he has recently heard of issues with Canadian Inspectorate baseless “findings” at CAICR member sites and also heard concerns expressed by IRB Services clients.
It was suggested that members who have been subject to health Canada audits share any concerns about unprofessional conduct of inspectors and findings which are outside the regulations with him so we can identify issues and present our concerns to senior management at the Inspectorate.
Pierre Gervais suggested CAICR should look into establishing a resource within the organization to assist members with responses to inspection reports.
Jack also updated the membership on the most recent Senate Standing Committee on Science, Technology and Social Affairs meeting he was invited to attend by Dr. Kelvin Ogilvie (Chair), which was also investigating a number of aspects of health care and the pharmaceutical industry, including clinical trials. The Senate is moving forward with the recommendation they published in 2012. He noted most of the issues being addressed do not offer much benefit to the private research sector and we continue to monitor any activities with a potential negative impact for Canada, however Dr. Ogilvie is well aware of our importance and supports inclusion.
Stephen Garland presented the fiscal report for last year and the current financial update for this year.
It was noted that the financial support for our proposal to RX&D we anticipated to receive in December of last year did not materialize. Initially we thought it was merely a delay. Follow up meetings unfortunately confirmed that RX&D is no longer prepared to fund the project.
Stephen also noted that we are seeking to change accountants. At this time our financial reporting is relatively straight forward and we believe we do not need a large accounting firm.
Elena presented an overview of the events that led to the creation of a Canadian Clinical Trials Asset Map. She noted the project is supported by government ,CIHR and RX&D. The goal is to have full representation within the web site of Canadian companies and individuals interested in conducting all aspects of clinical research in Canada.
She noted that there would not be any cost to those posting their information on the site, and the site would be available free of charge for those seeking to identify research capabilities in Canada. The MAP is open to organizations and also individuals .
A question was asked about how a Site Management Organization should best list their member physicians. Elena recommended that the SMO create an account and the individual physicians also create their own account .She noted that the system then allows for linkages to be set up so that users searching for investigators would be able to identify any affiliations of the investigator revealed in their search. It was also noted that the onus will be on the account holder to insure that information is current and accurate.
Elena noted that several CAICR members have assisted with the first test phase and she extended the offer for all members to open their accounts and if interested provide feedback in the next phase of testing.
The introduction was followed by a live demonstration of the current version of the web site. The functionality from an account holder, as well as an end user (sponsor, CRO etc) perspective was demonstrated.
The site launch is planned for early next year and members were again encouraged to post during the test phase.
Jack thanked Elena for her presentation and for including CAICR from the outset of this important initiative.
Clinical Trials in Canada Update:
Ronald Fehst presented an update clinical trials activity in Canada with a focus on types of studies, number of studies and number of sites allocated to Canada. The data is pulled from clinical trials registries (CT.GOV & Center Watch). Members were provided with a spreadsheet prior to the meeting .My slides will be attached to the agenda. The data captures new clinical trials sponsored by industry based on date posted. The majority of sponsors now post studies before or on the scheduled project start date, but a few are not reporting until a project is fully recruiting.
It is also important to note that this data does not include studies started in prior years that added Canadian sites later. ( In future this data will be presented in a separate report).
Additionally collecting data on Phase I and PK/PD studies remains difficult since few of these studies are reported to any registry.
Priorities Moving Ahead:
Jack opened a discussion of expanding CAICR and how best to increase membership.
It was noted that our planned e mail membership drive was not initiated as we had concerns about the impact on such a campaign of the new Canadian Anti Spam legislation. Elena mentioned that CCTAM had sought legal advice since they also planned to reach out to Canadian researchers via the internet, and they were going to take this approach.
There was also discussion of potentially refining the membership criteria, but no final decision was made and it was agreed that the priority should be to focus on those directly involved in clinical research in the private sector.
Jack also mentioned that the Board is looking for membership input to develop key priorities for the next year.
Pierre Gervais also provided an overview of the successes and issues of the Quebec association he founded a few years ago. He noted that the educational meetings they facilitated were well received. He also recommended we should look for opportunities to partner with other companies.
Jack moved to adjourn the meeting, seconded by Stephen.
Adjournment: Meeting Adjourned at 8:10 PM
Minutes submitted by: Ronald Fehst
CAICR members will be presenting at the November 6, 2014 CRAC/ACRP conference "CLINICAL TRIALS IN CANADA: CURRENT ISSUES & HOT TOPICS" held at the Toronto Airport West Hotel.
PANEL: Private vs. Academic Clinical Trials in Canada
Jack Corman, BSc, BEd, Founder and President, IRB Services, Aurora, ON
Patricia Jones, ART, RAC (CAN/US/EU), Director, Quality and Regulatory Compliance, Therapeutic Products Inc.
Deepen Patel, M.D., CCFP, CPI, Managing Medical Director, Topstone Research
Graham Wood, PhD, Chief Executive Officer, Manna Research
Richard Casey, M.D., F.R.C.S. (C) Chief Executive Officer, CMX Research
PANEL: Private and Academic Clinical Research in Canada: CAICR and CTO Perspectives Jack Corman, BSc, BEd, Founder and President, IRB Services, Aurora, ON
Erin Bell, Streamlined Ethics Review Program Coordinator, CTO, Toronto, ON
Manal Siddiqui, Manager, CTO, Toronto, ON