The document summarizes information about clinical trials and Clinical Trials Ontario (CTO). CTO aims to strengthen Ontario's clinical research capabilities by streamlining ethics reviews and trial agreements. It also works to increase public awareness of clinical trials and encourage participation. The summary describes key aspects of clinical trials such as phases, protocols, approval processes, and considerations for potential participants. Contact information is provided for CTO and the Canadian Cancer Survivor Network.

1. Clinical Trials 101 & Clinical Trial
Participation
Webinar for the Canadian Cancer Survivor Network
Dawn Richards
Director, Patient & Public Engagement
November 2, 2017

2. OUR VISION
To make Ontario a preferred location for global
clinical trials, while maintaining the highest
ethical standards.
OUR MISSION
To strengthen, promote and capitalize on
Ontario’s competitive advantages to
conduct high-quality clinical trials.
About Clinical Trials Ontario
• Supported by the Ontario Ministry of Research, Innovation and Science
• Established to address the decline in clinical trials in Ontario and leverage
Ontario’s clinical research capabilities to attract more trials

3. FOCUS 2016-21: CTO strategic priorities
• Advancing the Streamlined
Research Ethics Review System
• Streamlining Clinical Trial
Agreements review and other
processes
• Supporting research sites for
improved performance
• Developing program tools and
supports
• Encouraging active involvement of
the public
• Increasing public awareness of
clinical trials
• Supporting healthcare providers
• Industry recognition of the
advantages of conducting clinical
trials in Ontario and Canada
• Awareness of the exceptional and
world-leading clinical research
conducted in the province
• Engagement with the broader
research community in advancing
and promoting initiatives that
improve the clinical trials climate in
Ontario

4. The world’s first clinical trial
• Recorded in the “Book of Daniel” in the Bible.
• Conducted by King Nebuchadnezzar of Babylon.
• Ordered his people to eat only meat and drink
only wine, a diet he believed would keep them
in sound physical condition.
• But several young men of royal blood, who
preferred to eat vegetables, objected. The king
allowed these rebels to follow a diet of
legumes and water —for 10 days.
• When Nebuchadnezzar's experiment ended,
the vegetarians appeared better nourished
than the meat-eaters, so the king permitted
the legume lovers to continue their diet.
Source: A. Bhatt, Perspect Clin Res. 2010 Jan-Mar; 1(1): 6–10. Evolution of Clinical Research: A
History Before and Beyond James Lind

5. James Lind (1716-94): First physician to conduct a
clinical trial
”On the 20th of May 1747, I selected twelve patients in the scurvy, on
board the Salisbury at sea. Their cases were as similar as I could have
them. They all in general had putrid gums, the spots and lassitude, with
weakness of the knees. They lay together in one place, being a proper
apartment for the sick in the fore-hold; and had one diet common to all,
viz. water gruel sweetened with sugar in the morning; fresh mutton-broth
often times for dinner; at other times light puddings, boiled biscuit with
sugar, etc., and for supper, barley and raisins, rice and currants, sago and
wine or the like.
• Two were ordered each a quart of cider a day
• Two others took twenty-five drops of elixir vitriol three times a day
• Two others took two spoonfuls of vinegar three times a day
• Two of the worst patients were put on a course of sea-water
• Two others had each two oranges and one lemon given to them every
day
• The two remaining patients, took an electary recommended by a
hospital surgeon”
Dr. James Lind's “Treatise on Scurvy” published in Edinburgh in 1753
Source: A. Bhatt, Perspect Clin Res. 2010 Jan-Mar; 1(1): 6–10. Evolution of Clinical Research: A History Before and Beyond James
Lind

6. James Lind’s clinical trial
“The consequence was, that the most sudden and
visible good effects were perceived from the use of
oranges and lemons; one of those who had taken
them, being at the end of six days fit for duty … The
other was the best recovered of any in his condition;
and … was appointed to attend the rest of the sick.
Next to the oranges, I thought the cyder had the best
effects …”
Dr. James Lind's “Treatise on Scurvy” published in Edinburgh in 1753
Source: A. Bhatt, Perspect Clin Res. 2010 Jan-Mar; 1(1): 6–10. Evolution of Clinical Research: A
History Before and Beyond James Lind

7. Clinical trials
• Research studies that explore whether a medical strategy, treatment, or device is safe
and effective for humans. These studies also may show which medical approaches work
best for certain illnesses or groups of people
• Involve an intervention, i.e., test something; different from health questionnaires, chart
review studies etc.
• Often one of the final stages of a long and careful research process. For example, with
drug development, research first takes place in a lab and then in animals
• Produce the “best data available” for health care decision making
• May find that a new strategy, treatment, or device improves patient outcomes; offers no
benefit; or causes unexpected harm
• All of these results are important because they advance medical knowledge and help
improve patient care

8. Phases of clinical trials
Phase 0
•Effect on the body
Phase 1
•Safety, dose, side effects
•Duration of weeks
•Small number of participants (usually healthy) (20-80)
Phase 2
•Does the treatment do what it is supposed to do? Should the dose
be changed? Side effects
•Duration of months
•Larger number of participants (100-300)
Phase 3
•How long effects last, side effects
•Duration of years
•Large number of participants (1000s)
Phase 4
•Long term treatment effects and any side effects)
•Duration of years (ongoing)
•Large population

9. Clinical trials in a nutshell
Approved
protocol
Investigator
selection
Approval
process
Participant
recruitment
Data entered
& reviewed
Data analysis
Presentation &
publication of
results
Data filed &
registration
obtained

10. Development of clinical trials / protocols
Industry Sponsored
Pharma, medical devices, biotech
Focus is developing treatments that:
•Improve health/well being
•Provide data to have products approved for
use, or expanded use
Investigator Initiated
Physicians & health care providers,
university professors
Focus is developing treatments that:
•Improve health/well being
•Advance science
Usually grant funded, through
competitive processes

11. Protocols
Clinical trial protocols are usually lengthy, detailed documents that provide the information
regarding why the trial is being done, who it will involve, how it will be done and how the
results will be gathered, analyzed and shared.
Typical parts of a clinical trial protocol:
• Scientific/medical justification for the trial; may include lab/animal results, prior clinical trial
results
• Key measurements or “endpoints” for the trial (e.g. disease remission, survival, quality of life,
side effects)
• Who can and can’t be in the trial (eligibility and ineligibility criteria)
• The number of participants needed for the trial (and why)
• Exactly what treatments will be used and how; adjustments to treatment
• Assessments – when and what, e.g. doctors visits, blood tests, questionnaires
• Safety reporting
• Data collected
• How results will be analysed and shared
• Sample consent form for participants

12. Investigator selection
Investigators must be qualified to conduct the trial
Industry Sponsored Trials
Many are conducted in locations around the world. In selecting investigators industry
may consider:
• Investigator (e.g. physician) expertise – KOLs or Key Opinion Leaders
• Where they can get the trial started and finished efficiently
• Where potential patients may be
• Where they might want to market their product
Investigator Initiated Trials
Multi-site trials—may access an investigator network
• Cost may be an issue

13. Approval process for clinical trials
Regulatory Approval
• Health Canada receives
and reviews clinical trial
application for
pharmaceuticals,
biologics, medical devices
and natural health
products
• Trials can not proceed
until this approval is in
place
Research Ethics
Approval
• Protocols and information
to participants must be
approved by a research
ethics board (REB)
• REB focuses on the ‘ethical
acceptability of the
research’ - risks and
benefits and protecting
the rights of participants
Institutional
(hospital/university)
Approval
• Each institution must
approve the research
taking place under its
auspices

14. Clinical trials in a nutshell
Approved
protocol
Investigator
selection
Approval
process
Participant
recruitment
Data entered
& reviewed
Data analysis
Presentation &
publication of
results
Data filed &
registration
obtained

15. Clinical Trial Participation

16. CTO patient & public engagement
• Encouraging active involvement of the public
• Increasing public awareness of clinical trials
• Supporting healthcare providers

17. Who CTO is aiming to help
Patient Participant
Public

18. Protection of participants
If you have been asked to volunteer to participate in a clinical trial, there are a few
things that you should know and think about when considering your decision.
• Clinical trials must follow regulations and ethical standards.
• Clinical trials must be reviewed and approved by a Research Ethics Board. A Research Ethics
Board also provides ongoing oversight during the clinical trial.
• Every clinical trial should have a protocol that explains how the clinical trial will be conducted
and that has information such as potential benefits and risks, contact information, etc..
• Except for in a few unique cases, you will be asked to provide informed consent before the
clinical trial starts.
• Steps are taken to try to ensure confidentiality about participants.
• If you decide to participate in a clinical trial and you feel it’s no longer right for you, you can
stop participating at any time. You may be asked for a reason, but you do not need to provide
one if you don’t wish to.

19. Things participants may wish to consider
• Are you comfortable with the potential benefits and risks? Have these been
explained to you in clear language that you understand?
• Are you happy with and do you understand the responses to questions you
have about the clinical trial? Do you know that there is a protocol for the
clinical trial? Do you feel able to make an informed decision about your
participation?
• Are you comfortable with and trust the healthcare provider or research
team you are working with?
• Have you been asked to pay to participate in the clinical trial?
• E.g. parking, transportation
• There should not be a fee to participate in the clinical trial itself.

20. Finding a clinical trial
• Talk to your healthcare provider(s).
• Contact an organization that may be able to help you find a clinical trial.
• Search a website such as:
• www.canadiancancertrials.ca
• www.health-products.canada.ca/ctdb-bdec/index-eng.jsp
• www.clinicaltrials.gov.
• Contact an academic research centre.

21. Contact information
Website: www.ctontario.ca
E-mail: dawn.richards@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

22. Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone / Téléphone : 613-898-1871
E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca
Web site www.survivornet.ca
Instagram: @survivornet_ca
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/
Canadian Cancer Survivor Network
Contact Info