Ontario Cancer Research Ethics Board
MaRS Centre, Suite 510 | 661 University Avenue
Toronto, Ontario | Canada M5G 0A3
416-673-6649 or 1-866-678-6427 ext. 6649 | www.ocreb.ca
Monthly Teleconference Summary
October 2, 2015 – 9 to 10 a.m.
ATTENDEES
1.
2.
3.
4.
5.
6.
Sites: 7.
8.
9.
OCREB:
10. Sunnybrook Health Sciences Centre
 Odette Cancer Centre
11. Toronto East General
12. Trillium Health Partners - Credit Valley Hospital
13. UHN - Princess Margaret Cancer Centre
 Clinical Trial Support Unit
 Drug Development Program
 Medical Oncology & hematology
 Radiation oncology
14. William Osler Health Centre
15. Hamilton Health Sciences (JCC)
Aurora de Borja, Terry Liu, Janet Manzo, Richard Sugarman (Chair), Alison van Nie, Mark Whissell
(VC), Kathie Zeman
REGRETS
16.
17.
18.
19.
Sites:
20.
21.
22.
OCREB:
Lakeridge Health (Oshawa)
Lawson (London) - LRCP
Markham Stouffville
McMaster Children’s Hospital
Niagara Health System
North York General Hospital
The Ottawa Hospital Cancer Centre
Royal Victoria Regional Health Centre
Southlake Regional Health Centre
Cambridge Memorial
Grand River Hospital
Health Sciences North (Sudbury)
Humber River Hospital
Kingston General Hospital
Kingston General – Pediatrics
Mount Sinai Hospital
23.
24.
25.
26.
27.
28.
29.
30.
SickKids (Toronto)
St. Joseph’s Healthcare (Hamilton)
St. Joseph’s Health Centre (Toronto)
St. Michael’s Hospital
Thunder Bay Regional Health Sciences Centre
Trillium Health Partners - Mississauga Hospital
Windsor Regional Hospital
Women’s College Hospital
Yooj Ko (VC), Cindy Sandel,
If you temporarily have to leave the teleconference, please hang up and dial in again when you are able to re-join.
Putting your phone on hold causes interference with all of the other lines.
NOTEWORTHY ITEMS
A place for sharing new information, updates and other noteworthy items affecting the research community.
1. Genomic testing in cancer patient knowledge, attitudes and expectations, Cancer October 1, 2014. Phillip S.
Blanchette, MSc, MD; Anna Spreafico, MD, PhD; Fiona A. Miller, PhD; Kelvin Chan, MD; Jessica Bytautas,
BA; Steve Kang, HBSc; Philippe L. Bedard, MD; Andrea Eisen, MD; Larissa Potanina, MD; Jack Holland, MD;
Suzanne Kamel-Reid, PhD; John D. McPherson, PhD; Albiruni R. Razak, MD; and Lillian L. Siu, MD
Genomic testing in cancer (GTC) characterizes genes that play an important role in the development and
growth of a patient’s cancer. This form of DNA testing is currently being studied for its ability to guide cancer
therapy. The objective of the current study was to describe patients’ knowledge, attitudes, and expectations
toward GTC.
RESULTS: Results were reported from 98 patients with advanced cancer, representing 66% of the patients
surveyed. Seventy-six percent of patients were interested in learning more about GTC, and 64% reported that
GTC would significantly improve their cancer care. The median score on a 12-item questionnaire to assess
knowledge of cancer genomics was 8 of 12 items correct (67%; interquartile range, 7-9 of 12 items correct
[58%-75%]). Scores were associated significantly with patients’ education level (P<.0001). Sixty-six percent of
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patients would consent to a needle biopsy, and 39% would consent to an invasive surgical biopsy if required
for GTC. Only 48% of patients reported having sufficient knowledge to make an informed decision to pursue
GTC whereas 34% of patients indicated a
need for formal genetic counselling.
CONCLUSIONS: Patients with advanced cancer are motivated to participate in GTC. Patients
require further education to understand the difference between somatic and germline mutations in the context
of GTC. Educational programs are needed to support patients interested in pursuing GTC.
Cancer 2014; 120:3066-73. VC 2014 American Cancer Society.
Blanchette
Cancer.pdf
NEWS
1. A Faster Way to Try Many Drugs on Many Cancers – basket studies
http://www.nytimes.com/2015/02/26/health/fast-track-attacks-on-cancer-accelerate-hopes.html?smid=lishare&_r=1
2. Race & institutional factors play an important role in pharmacogenetics trial participations
http://www.eurekalert.org/pub_releases/2015-07/hlmc-ri072715.php
3. Update re NPRM: http://www.quorumreview.com/blog/2015/09/04/nprm-2015-summary-post/
NOTICES
Change in OCREB Meeting Deadline Date
Effective October 2015 (i.e., for the November meeting), the deadline for submissions for the OCREB meetings will be
by end of day on the Tuesday two weeks prior to the meeting.
Adding Study Personnel to Application Forms
Please do not add PIs, Co-Investigators or Study Staff in duplicate sections of the application. There are specific fields
to enter the PI, Co-investigators and relevant study staff. Entering them again in another section changes their access.
Department Approver Glitch
There is a system glitch the sometimes does not allow the Department Approver (DA) to see and execute the
application approval activity. There is a system workaround, so please have someone contact O2 Support if the DA
cannot see the approval button. The issue has been logged and we are working on a fix to implement in the next
system patch.
An optional statement in the confidentiality section of the Main ICF template
Your initials and medical record number may be entered into a clinical trial management system for research
administration and quality assurance purposes only. The management system is a controlled access system to ensure
the confidentiality and security of the data. The database of the system is housed at Ontario Institute for Cancer
Research (OICR), in a secure environment. The management system assists sites in the project management of their
trials and also enables the Canadian Cancer Clinical Trials Network (3CTN) to collect de-identified metrics for reporting
on clinical trial activity in Canada. Access to the information in the system at this centre is limited to members of the
research team. Information in the system will be used for the described purposes and the information/data will not be
shared with any unauthorized parties or personnel.
Notice from NCIC CTG
OCREB Approval of Patient-Reported Outcomes (PRO) Materials
For all types of NCIC CTG trials, OCREB requires that any PRO/participant materials are uploaded separately as
individual documents during the on-line submission (O2) process. This includes PROs that are embedded in the
protocol. The OCREB members reviewing these materials need to see the documents as they would be presented to
participants and not as pages from the protocol with headers and footers. If the actual PROs are not yet available to
the provincial applicant (PA), as is the case with some Inter-group sponsors who provide them ONLY at the time of
participant enrollment, the PA will need to communicate this to OCREB to determine an acceptable alternative.
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Submission of Centre ICF with initial application
OCREB is considering requiring the submission of the centre-specific ICF with the initial centre application.
O2 Training
Hands-on new user, refresher training and advanced training sessions can be made available via webcast for
provincial or centre applications. On-site training (i.e., at the centre) can be arranged if there are enough attendees.
For those in the GTA, training at the OCREB office also can be arranged. The next training sessions are scheduled for
Thursday, October 8 from 1 to 5pm. Please contact Kathie Zeman or Aurora de Borja to arrange O2 training.
REMINDERS
Centre-specific, pre-approved ICF Changes
Please review any centre-specific changes under the organizational profile in O2 and notify Alison van Nie if there are
any updates/revisions to the information. Alison.vannie@oicr.on.ca
CR submission reminder
OCREB no longer will provide a summary of CR applications due for the upcoming board meeting. Be sure to keep
track of the expiry dates of your studies. The system sends courtesy reminders 49 days, 15 days and 1 day prior to the
expiry date.
Compensation section of the ICF
Please remember to revise the compensation section of the provincial ICF (as applicable) – insert pre-approved, or
study/centre specific information for study-related participant costs.
Access to Studies
If your Centre PI was not added by the Provincial Applicant to the provincial application, please send a request to O2
Support (via email) to have the PI added to the study. Please refer to the O2 Support Request Guidelines from O2
Home for information about requesting O2 accounts or O2 access.
Unsubscribe request is no longer valid
Due to recent administrative changes, it no longer is possible to maintain two contact lists and to unsubscribe from
OCREB communications. All study staff and centre representatives with active O2 accounts (i.e., accounts that have
not been deactivated), will remain on the contact list for OCREB communications. If you have colleagues wishing to
attend the monthly teleconferences, please forward the emails to them.
Request for password for PI
Please remember to include the PI’s first name and/or initials when a request is made for a password. There are users
with the same last name and the initials/first name is required for identification purposes.
OCREB Membership Changes
The OCREB membership roster was last updated on 2015-08-01. The current and archived membership lists can be
accessed from https://ocrebonline.ca under “Member Lists”.
Project Submission Summary List
The list of studies with OCREB (project submission summary spreadsheet) is available on the O2 Home page
https://ocrebonline.ca. The current version posted is from Sep 25, 2015.
OCREB ONLINE (O2)
Key Recent Enhancements – N/A
See also the “What’s New” section of O2 Home - https://ocrebonline.ca
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STUDY SUBMISSION STATUS
For a list of all studies with OCREB, see the Project Submission spreadsheet at https://ocrebonline.ca
New studies submitted for the October meeting:
15-080
Cindy
NCIC
MA.36 (BIG 6-13)
(D081CC00006)
Andrea
Eisen
15-081
Kathie
COG
ARST1321
Abha Gupta
HSC
15-082
Kathie
CNTRP
CNTRP-140
Dennis Kim
UHN-PM
Aquila Farrell
15-083
Cindy
Xbiotech
2012-PT023
Eric Chen
UHN-PM
Bonnie Kwan
15-084
Aurora
Aragon
56021927PCR3003
Hans Chung
15-085
Aurora
JoLT-Ca
STABLE-MATES
Gail Darling
SHSC
SHSC
UHNTGH
Carolyn Lim
Nivetha
Ramachandran
Andrea DeAbreu
Frances Allison
Studies in Pre Submission:
IIS
Exelixis
18F-FDG
Katherine Zukotynski
SJHC
XL184–401
Krzyzanowska, Monika
UHN
Amirah Shahin
Other Potential Studies:

Vascular Biogenics Ltd. Therapeutics "A Phase 3, Randomized, Controlled, Double-Arm, Open-Label,
Multi-center Study of VB-111 Combined with Bevacizumab vs. Bevacizumab Monotherapy in Patients with
Recurrent Glioblastoma". Protocol No: VB-111-215. CRO: PPDI. Lawson – Dr. David Macdonald.
CONTINUING REVIEW APPLICATIONS
Be sure to keep track of the expiry dates of your studies. The system sends courtesy reminders 49 days, 15 days and
1 day prior to the expiry date.
For studies expiring November 13 to December 10, inclusive, provincial and centre continuing review applications
are due by the Tuesday, October 27 deadline for the November 13 meeting, unless a study closure has been or will
be submitted.
Next OCREB teleconference: November 6, 2015 @ 9:00am
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