Clinical Trials OntarioMaking 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

Improving Participant

Recruitment and

Retention

Promoting Ontario and Attracting

Investments

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 high-quality 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 Program2. 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

REB application submitted by any registered investigator/site, i.e. “Provincial Applicant”

CTO assigns Board of Record (any Qualified REB in Ontario) and advances application

Board of Record reviews application and resolves any issues with applicant

Once issues are resolved Board of Record approves study

Site adopts approved Informed Consent Form. Submits site application focused on

site specific information

Site application advances to Board of Record

Board of Record reviews application (usually expedited) and resolves any

issues with site applicant

Step 1Applying for a New Multi-Centre

Clinical Trial

Step 2 Adding New Investigators /

Research Sites

Initial Application Process

Participating sites are notified and given access to REB materials in CTO system

Board of Record issues approval for site to participate

Documentation submitted by “Provincial Applicant”

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

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 research site

Delegated Board of Record Model

Continuing Oversight and Approval

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 ENGAGEMENTPhase 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 sessions1. 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 Environment3. The Investigative Site Perspective4. Participant Engagement

Targeted Workshops – Day 21. Ethical and Privacy Issues in Clinical Research2. 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 Ontario661 University Avenue, Suite 460MaRS Centre, West TowerToronto, Ontario Canada M5G 1M1 Tel / 416.276.1381