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Case Study: Engagement in Clinical Trials

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Case Study: Engagement in Clinical Trials

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Dr. Dylan MacKay shares his experiences in early engagement in clinical trials.

CHI's Lunchtime Learning is open to all researchers, decision-makers, clinicians, patients and members of the public who want to learn more about the theory and practice of meaningful, inclusive, and safe patient and public engagement.

Dr. Dylan MacKay shares his experiences in early engagement in clinical trials.

CHI's Lunchtime Learning is open to all researchers, decision-makers, clinicians, patients and members of the public who want to learn more about the theory and practice of meaningful, inclusive, and safe patient and public engagement.

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Case Study: Engagement in Clinical Trials

  1. 1. ENGAGING IN CLINICAL TRIALS PE Lunchtime Learning Case Study: Dylan MacKay, PhD and learning from failure
  2. 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. 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. 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. 5. Maybe the 1st clinical trial ? • 1747, 12 (with scurvy) • 6 treatments (n=2 each) James Lind (1753) A treatise of the scurvy +
  6. 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. 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. 8. Key principles of engagement • Transparent • Inclusive • Supportive • Mutual respect • Mutual benefit
  9. 9. SO WHEN DO YOU START ENGAGEMENT IN CLINICAL TRIALS?
  10. 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. 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. 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. 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. 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. 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. 16. This is basically what I did with my list half-way through the engagement session
  17. 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. 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. 19. Hans Kai Trial: an Evaluation of a Peer-led Preventative Health Intervention • My list before was: • HbA1c • Blood pressure • Waist circumference
  20. 20. Hans Kai Trial: an Evaluation of a Peer-led Preventative Health Intervention
  21. 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. 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. 23. HOW DO I START ENGAGEMENT?
  24. 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. 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. 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. 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. 28. ASSESSING PATIENT ACCEPTANCE OF ALTERNATE DIETARY THERAPIES TO IMPROVE PROTEIN MALNUTRITION IN PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD)
  29. 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. 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. 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. 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. 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. 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. 35. • Engagement is not easy, and the process will be educational • Engagement is worthwhile and makes clinical trials better Conclusions

Editor's Notes

  • Title: PE Lunchtime Learning Case Study: Engaging in Clinical Trials
    Learning Objectives: By the end of the session, attendees should be able to
    Describe the importance of engaging patient partners in clinical trials
    Describe methods for involving patient and public partners in clinical trials
    Discuss ways to overcome barriers to engagement in clinical trials
    Bio: Dr. Dylan MacKay is a Clinical Trialist with the George & Fay Yee Centre for Healthcare Innovation, Assistant Professor in the Department of Community Health Sciences at the University of Manitoba.  Dylan has a PhD in Human Nutritional Sciences and specializes in diabetes and chronic kidney disease. He received a PREPPP Award to support early patient and public engagement for his project titled Assessing Patient Acceptance of Alternate Dietary Therapies to Improve Protein Malnutrition in Patients with Chronic Kidney Disease (CKD).
    Description: In this session, CHI PREPPP Award winner Dr. Dylan MacKay will share his experiences in involving patients and members of the public in the early stages of clinical trial design and grant development.
     
  • sulfuric acid and alcohol and acetic acid
  • Kind of ironic given his trial
  • Inclusiveness (i.e. integrating a diversity of public and patient perspectives, with research reflecting these contributions);
    Support for public and patient partners to be able to fully contribute (i.e. creating safe environments, anti-oppressive and trauma-informed approaches, appropriate training, education, and compensation);
    Mutual respect and partnership (i.e. the value of experiential knowledge is recognized by all research team members);
    Co-building (i.e. public, patients, researchers and practitioners work together from the beginning to identify problems and gaps, set priorities for research, and collaboratively produce and implement solutions);
    Co-learning (i.e. patient and public partners learn more about the research process and researchers learn more about patient-centred engagement);
    Reciprocal relationships (i.e. shared power and decision-making); and
    Transparency, honesty and trust (i.e. open communication, reflexive practice, and conflict resolution).
  • PREPP award
  • ×