1. ENGAGING IN CLINICAL TRIALS
PE Lunchtime Learning Case Study:
Dylan MacKay, PhD
and learning from failure

2. Disclosures
• I work at a CIHR Strategy for Patient-Oriented
Research (SPOR) SUPPORT unit
• I am a person with type 1 diabetes and a patient
partner on other researchers’ projects

3. Disclosures
• I am an early career researcher
• So I am new at this, I learn new things every day
• Often by making mistakes
• I am always a little surprised people listen to me
about anything

4. Clinical trials
• A research study in which one or more
human subjects participants are prospectively
assigned to one or more interventions (which
may include placebo or other control) to
evaluate the effects of those interventions
on health-related biomedical or behavioral
outcomes. – NIH (edits by me)

5. Maybe the 1st clinical trial ?
• 1747, 12 (with scurvy)
• 6 treatments (n=2 each)
James Lind (1753) A treatise of the scurvy
+

6. Engagement
• “the meaningful and active involvement of
patients in the governance, priority setting,
[and] conducting of research and
knowledge translation”– CIHR
• ‘with’ or ‘by’ members of the public instead
of ‘to’, ‘about’ or ‘for’ - NHS

7. • Address the mismatch between what
researchers want to research, and the needs of
patients and health professionals
• Researchers may address
questions of importance to
patients and clinicians, but
still fail to provide answers
that are useful in practice

8. Key principles of engagement
• Transparent
• Inclusive
• Supportive
• Mutual respect
• Mutual benefit

9. SO WHEN DO YOU START
ENGAGEMENT IN CLINICAL
TRIALS?

10. Before the trial exists!
• You want to start your engagement when
you are coming up with the idea for the trial
• Even before you talk to your biostatistician
• Ideally the idea for a trial can come from
patient and public priority setting
• You could even co-design trials with patients

11. • PI: Dr. Jon McGavock (I’m a patient
partner/co-applicant)
• Following up James Lind style priority setting
• training researchers and patient partner
• Co-design a discreet choice experiment
• Use results to co-develop clinical trials
Engaging persons living with type 1 diabetes and their caregivers
to develop an intervention to determine optimal strategies
to exercise safely

12. • Virtual rather than in person
training is happening now
• The changes have been
made with the partners
involved
Engaging persons living with type 1 diabetes and their caregivers
to develop an intervention to determine optimal strategies
to exercise safely

13. • Hans Kai is a peer-led program for people
wanting to maintain or improve their health
• Hans Kai started in Winnipeg in 2009 at the
Norwest Co-op and was co-designed with
input from key community stakeholders
Hans Kai Trial: an Evaluation of a Peer-led Preventative
Health Intervention

14. • Norwest co-op wanted to conduct a clinical
trial on the Hans Kai program
• They approached the U of M and eventually
ended up with me
• We decided it was best to listen to people
who had been in the program to help inform
the design of the trial
Hans Kai Trial: an Evaluation of a Peer-led Preventative
Health Intervention

15. • We wanted to pick the best outcomes for the
trial
• Norwest assembled a team of Hans Kai
participants and Han Kai facilitators
• I had developed my own list of outcomes
before the engagement meeting
Hans Kai Trial: an Evaluation of a Peer-led Preventative
Health Intervention

16. This is basically what I did with my
list half-way through the
engagement session

17. Hans Kai Trial: an Evaluation of a Peer-led
Preventative Health Intervention
• My list was so far off
• I had read a description of the program
from a previous publication
• Participants in the program had lived it
• There was some overlap between the
participants and coordinators lists (they
made lists separately)

18. Hans Kai Trial: an Evaluation of a Peer-led Preventative Health
Intervention
• Final list that participants ranked identified
three top outcomes:
• Connection/friendship
• Health knowledge
• Healthy behavior change

19. Hans Kai Trial: an Evaluation of a Peer-led Preventative Health
Intervention
• My list before was:
• HbA1c
• Blood pressure
• Waist circumference

20. Hans Kai Trial: an Evaluation of a Peer-led Preventative Health
Intervention

21. • The engagement session with program
members helped inform other trial elements too
– Randomization and allocation
– Inclusion and exclusion criteria
Hans Kai Trial: an Evaluation of a Peer-led Preventative
Health Intervention

22. • The engagement session with program
members helped inform other trial elements too
– Randomization and allocation
– Inclusion and exclusion criteria
Hans Kai Trial: an Evaluation of a Peer-led Preventative
Health Intervention

23. HOW DO I START
ENGAGEMENT?

24. Step 1: Get some money
• Start-up funds
• CIHR catalyst or Planning and
Dissemination Grants
• PREPP awards
• Ask local SPOR SUPPORT units
• Personal credit cards (not recommended)

25. Step 2: Spend money
• Find ways interact with the populations of
interest
• Information sessions
• Focus groups/interviews
• Surveys
• Look for people who want to contribute more

26. Step 3: build relationships
• Most clinical research comes down to
relationships
• Engagement in clinical trials is the same
• Respect/transparency/value
• Compensate people and cover their costs
• Manage expectations

27. Step 4: maintain relationships
• Check in with partner, especially between
grants
• Make sure the roles are working for them
• Make sure they do not feel trapped
• Ask them if they have new ideas
– But only if you have time to help them

28. ASSESSING PATIENT
ACCEPTANCE OF ALTERNATE
DIETARY THERAPIES TO
IMPROVE PROTEIN
MALNUTRITION IN PATIENTS
WITH CHRONIC KIDNEY DISEASE
(CKD)

29. My first funded grant
• It was only $2000 (a PREPP)
• But we conducted some focus groups on
nutrition recruiting from an existing cohort
study
• Protein was not really something the people
really cared about
• Dietary interventions and restrictions were

30. Research programs grow
• The first paper from the focus groups is in
preparation
• Quotes and themes from the focus groups are
being used in grant applications to establish
the “why” for some trials
• So far all the grants (2 x Research Manitoba
NI, 1 CIHR project) have not been funded :>(

31. • Failure and rejection are a big part of research
• I like to let partners know this up front
• Most grants don’t get funded (unfortunately)

32. Using fruits and vegetables to reduce the
amount of acid in the diets of people
living with CKD
• This planned trial has 2 patient partners
• One will sit on the trial steering committee
• That partner has a research background
(bonus)
• They have been involved in the grant writing
and (re)submission process

33. • I recommend letting partners shape their own
roles whenever possible
• People tend to do better doing things they want
to do
• Even when you are compensating partners
they are choosing to help
The right partner for the right job

34. Barriers to engagement
Barriers
• $$$
• Time
• The researchers
themselves
Solutions (maybe)
• Keep trying, get lucky?
• There is not solution
other than to make the
time or not do it
• Education, experiencing
the value, advocacy

35. • Engagement is not easy, and the process will
be educational
• Engagement is worthwhile and makes clinical
trials better
Conclusions