Transcript Document

Clinical Trials Ontario
Making Ontario a preferred location for global clinical trials,
while maintaining the highest ethical standards
Susan Marlin, President and CEO
LEXPERT Life Cycle of Pharmaceuticals Conference
November 4, 2014
ABOUT CLINICAL TRIALS ONTARIO
 Clinical Trials Ontario is an independent not-for-profit organization
 Established with seed funding from the Province of Ontario– $4.5 million over 4 years in
response to:
 Significant decline in clinical research in Ontario – pharma investment
 2009: $550m | 2010: $500m | 2011: $438m | 2012: $368m
 Recognition of Ontario’s strengths (e.g. excellent research capacity, high quality data)
and areas to improve (e.g.speed, cost)
 Mandate for CTO – support a streamlined approach to conducting multi-centre clinical
trials in Ontario while ensuring the highest ethical standards for patient safety
Streamlining
REB and
other CT
Admin
processes
Promoting
Ontario and
Attracting
Investments
Improving
Participant
Recruitment
and
Retention
Corporate Projects
Operations & Governance
Engagement of the Clinical Trials Community in Ontario
CTO Streamlined Research Ethics Review System
The CTO System is expected to provide significant benefits to sponsors, investigators, institutions
and REBs conducting multi-centre clinical research by harmonizing processes and reducing time
and effort required to initiate research across multiple sites in Ontario.
 Supports a single REB in providing research ethics review and oversight to multiple
research sites
 Can be used for any multi-site clinical research, i.e. industry sponsored or investigator
initiated
 Ensures that all REB reviews done through the CTO system are conducted by highquality REBS that have achieved Qualification status
 Investigators/applicants will use the same interface and REB application forms,
irrespective of which REB is providing oversight; Consistency in submission requirements
 Two primary components:
1. CTO REB Qualification Program
2. CTO Stream - web-based information technology system that will enable
research ethics reviews, document management and communication across
multiple REBs and institutions
CTO REB QUALIFICATION PROGRAM

 Provides an external review and qualification of REBs in Ontario planning to
participate in the CTO Streamlined Ethics Review System.
 Qualification Manual and process based on the Toronto Academic Health
Sciences Network (TAHSN) REB Qualification Manual with amendments:
 Qualification Checklist/Standard
 Based on applicable ethics review regulations, policies etc. including the CGSB;
has undergone two external expert reviews
 Qualification Review Team
 includes an experienced auditor and 1-2 members of the REB community – an
experienced Chair/Vice-Chair and an experienced REB Operational expert
 REB community members participating in reviews drawn from the CTO “College
of Reviewers”
 Qualification Review Outcome
 review identifies findings; once findings addressed “CTO Qualification” status
issued
 remains in effect for 3 years, with brief annual updates
CTO REB QUALIFICATION PROGRAM - STATUS
 College of Reviewers:
 5 REB Chairs & 4 Operational Experts Recruited
 REB Qualification Status:
 2 Qualified REBs
 2 REBs in process; 2 REBs scheduled for review
 4 additional requests expected by end of 2014
 REB Preparation for Qualification
 REB SOPs in place; N2/CAREB available now
 SOPs and procedures checked against the CTO REB qualification checklist (in the
manual at www.ctontario.ca)
 Complete questionnaire and schedule visit
 SOPs reviewed prior to on-site visit; 2-day on site visit - includes interviews with REB
Office team and REB Chairs/Vice-Chairs
 REB Chair/Operational lead invited to join CTO Res Ethics Review Governance Committee
CTO STREAMLINED ETHICS REVIEW SYSTEM
 Based on ‘delegated board of record model’; a qualified REB is delegated by participating
institutions the responsibility to provide ethical oversight for a clinical research study
conducted across multiple institutions – “one study, one REB”
 Infrastructure includes web-based e-REB system “ CTO Stream”, policies and procedures,
tools and education
 All applications for Research Ethics Review through the CTO system will go through the
CTO Stream application; all investigators and REBs will have the same interface
 CTO Stream based on Infonetica system, with multiple customizations
 Design/customization complete and undergoing UAT
 Pilot(s) this fall:
 Industry sponsored study
 Investigator led study
Delegated Board of Record Model
Initial Application Process
Step 1
Step 2
Applying for a New Multi-Centre
Clinical Trial
Adding New Investigators /
Research Sites
REB application submitted by any registered
investigator/site, i.e. “Provincial Applicant”
Site adopts approved Informed Consent
Form. Submits site application focused on
site specific information
CTO assigns Board of Record (any Qualified
REB in Ontario) and advances application
Site application advances to Board of Record
Board of Record reviews application and
resolves any issues with applicant
Once issues are resolved Board of Record
approves study
Participating sites are notified and given
access to REB materials in CTO system
Board of Record reviews application
(usually expedited) and resolves any
issues with site applicant
Board of Record issues approval for
site to participate
Delegated Board of Record Model
Continuing Oversight and Approval
New overall (study-level) event,
e.g. amendment, Data Safety Monitoring
Board report, safety update
New site level event, e.g. continuing
(annual) review, local Serious Adverse
Event, protocol deviation
Documentation submitted by “Provincial
Applicant”
Documentation submitted by research site
Board of Record reviews submission and
resolves issues with provincial applicant
Once issues are resolved, approval or
acknowledgement is issued by Board of
Record and sent simultaneously to all
approved participating sites
Board of Record reviews submission and
resolves issues with research site
Approval or acknowledgement issued by
Board of Record
ASSIGNING THE BOARD OF RECORD
Industry Sponsored/Led Studies:

CTO will look first at matching the study area to REB expertise

If more than one qualified REB with expertise, will assign REB based on balancing
workload of CTO studies amongst REBs
Investigator Led Studies:

Preference will be to assigning to the ‘home’ REB of the lead investigator; REB likely
to have the expertise, and some desire expressed in the community for having more
institutional support for Investigator led studies

If ‘home’ REB not possible, CTO will look to match REB expertise

If more than one qualified REB with expertise, will assign REB based on balancing
workload of CTO studies amongst REBs
CLINICAL TRIAL AGREEMENTS
Canada
• Cdn Clinical Trials Coordinating capacity – working with select industry
partners to advance model clinical trials contract for academic sites across
Canada
Ontario
• CTO has developed a model CTA for Ontario, starting with the draft national
model and incorporating input from across Ontario institutions
• Will be attempting to implement this with trials that go through the CTO
system for ethics review
• Predicted challenges
• Industry cannot get approval from ‘global’
• Industry has already negotiated a ‘template’ with individual sites
• Others?
• Solutions???
PATIENT AND PUBLIC ENGAGEMENT
Phase I: October 2014-March 2015

Communications: Provide/link to Clinical Trial Resources for patients/public

Information gathering:
 Participant/non-participant survey
 Outreach to CT professionals (surveys, focus groups, consultation)
 Potential public survey

Supporting/enhancing Clinical Trials Conduct
 Promoting discussions re: privacy/ethics issues relating to CTs – e.g.
recruiting, identifiers, accessing databases, linking data, future research;
focus ½ workshop at CTO conference
 Engaging public/patients in model consent form development,
design/development of any patient/public engagement programs, policy
development when appropriate
Phase II: April 2015-May 2016 - activities based on ‘learnings’ from phase I
CTO CONFERENCE 2015
 Scheduled for March 4-5, 2015 – Hilton, Toronto; agenda/speakers under development
 Theme: What’s Next for Clinical Research in Ontario and Canada
 Plenary - Day 1

Introductory Remarks:
 Bob Bell, Deputy Minister, MOHLTC

Four sessions
1. Building a global system for excellence in clinical research
 Keynote: Greg Koski, Co-Founder & President ACRES; former Director OHRP &
Investigator/Physician, Harvard
 Building a Global System for Excellence in Clinical Research base don
values of Integrity, Inclusiveness, Innovation and Implementation
2. Developments in the CT Environment
3. The Investigative Site Perspective
4. Participant Engagement
 Targeted Workshops – Day 2
1.
2.
Ethical and Privacy Issues in Clinical Research
CTO Streamlined Ethics Review System
CONTACT INFORMATION
Website: www.ctontario.ca
E-mail: susan.marlin @ctontario.ca
@clinicaltrialON
linkedin.com/company/clinical-trials-ontario
Clinical Trials Ontario
661 University Avenue, Suite 460
MaRS Centre, West Tower
Toronto, Ontario
Canada M5G 1M1
Tel / 416.276.1381