Clinical Trials Ontario

Patient & Public Engagement

At CTO, we’re committed to ensuring that patients and the public are actively involved with clinical trials. We support researchers and healthcare providers in their interactions with patients around clinical trials, encourage organizations and research teams to incorporate patient perspectives, and increase public awareness around clinical trials through programming and campaigns. Through the CTO College of Lived Experience and our work with health charities, patient organizations and public partners, we’ve delivered valuable tools and resources to a wide range of groups and communities. It’s these unique models of engagement that allow us to meaningfully involve patients and the public in our work.

Contents

Best Practices for Engagement

Have resources and a budget to support engagement

Resources may include a point person for all engagement activities, offering honoraria (individuals may or may not wish to receive it), covering travel and other expenses and more.
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Be flexible

Think about creating opportunities to meet outside of regular business hours, allow for different meeting time options (or even hosting the same meeting on different dates and times to increase attendance), meet one on one with those who can’t make times that work for the majority, facilitate meetings to encourage everyone to engage in ways that work for them, and provide both in person and virtual options to participate in meetings.

Communication icon

Communicate clearly

Set context and timelines for project engagement, offer tailored information to patient partners at a level that makes sense for them (which may not be the same information and materials you would provide others such as researchers or clinicians), create online, closed message boards to keep communication accessible.

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Close the loop

Let partners know about project results, outcomes and next steps based on their generous input and insights. Partners really appreciate knowing and seeing how their experiences and insights affect projects, and this is sometimes an overlooked, but important step to engagement.

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Engage a large group so there isn’t pressure to participate

This allows more perspectives plus allows individuals to step back if their health or life require them to, or if they’re simply not as interested in the topic at hand.

The College of Lived Experience

The College of Lived Experience provides patient- and public-centred advice on topics and issues related to clinical trials. The College serves as a resource for the clinical trials community, helping Clinical Trials Ontario and people who do clinical trials to better reflect the patient and public experience.
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Health Charities & Patient Organizations

CTO collaborates with health charities and patient organizations to empower their communities with respect to clinical trials. Together, we co-create impactful tools and resources to help meet their communities’ needs related to clinical trials. This partnership opens doors to collaborate on research projects, to provide input to various agencies about clinical trials, to attend and speak at research events, and to provide access to new clinical trial resources. If you’re interested in working with CTO, please reach out to info@ctontario.ca.

Organizations We Work With

Brain Tumour Foundation of Canada logo
Canadian Arthritis Patient Alliance logo
Canadian Breast Cancer Network logo
Canadian Cancer Survivor Network logo
The Canadian Continence Foundation logo
Canadian PKU & Allied Disorders Inc. logo
Canadian Skin Patient Alliance logo
Canadian Spondylitis Association logo
Colorectal Cancer Canada logo
Cystic Fibrosis Canada logo
Huntington Society of Canada
Leukemia & Lymphoma Society of Canada logo
Lymphoma Canada logo
Myeloma Canada logo
Mito Canada logo
Ovarian Cancer Canada logo
Canadian Psoriasis Network logo
Save Your Skin Foundation logo
Sickle Cell Awareness Group of Ontario logo

Resources

Participant Experience Toolkit

Provides guidance on how to make clinical trial participants feel informed and valued. Topics covered include: participant information and support, participant expense reimbursement, participant experience surveys, plain language result summaries, and thanking participants.

Learn About Clinical Trials

Basic information that was co-created with patient partners about what to expect as a participant and how to find clinical trials.

CTO Trial Finder

A search tool created with and by patient partners to help people look for a clinical trial.

Clinical Trials Glossary

A glossary of commonly used terms in clinical trials.

Educational Resources Package

To help organizations educate their own communities about clinical trials, we developed a package of downloadable resources, which were developed in collaboration with patients, patient organizations and health charities. Package materials include:

  • One-Pager — A printable handout that provides general information about clinical trials
  • PowerPoint Presentation — A slide deck that provides a basic overview of clinical trials. Talking points are provided in the notes section of each slide to help the presenter deliver the content.

To download the Educational Materials Package, please provide your contact information.

#TalkClinicalTrials

The #TalkClinicalTrials blog series explores different perspectives related to clinical trials. If you’ve personally taken part in a trial, supported a loved one who has, or been involved in some aspect of the clinical trials process, we’d love to hear your story. Email info@ctontario.ca or join the #TalkClinicalTrials conversation on social media.

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Research Publications

From time to time, CTO’s work related to patient and public engagement is published in academic, peer-reviewed journals. If you are interested in these publications, they are listed here and if you have any issues accessing one of these papers, please contact info@ctontario.ca.

Summary

The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomized trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance to early phase dose-finding trials with interim dose escalation or de-escalation strategies. The CONSORT-DEFINE guidance provides recommendations for items that should be reported in early phase dose-finding trials to promote greater clarity, reproducibility, informativeness, and usefulness of results.

Citation

Yap C, Solovyeva O, de Bono J, Rekowski J, Patel D, Jaki T et al. Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance BMJ 2023; 383 :e076387 doi:10.1136/bmj-2023-076387

Summary

SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for items that should be provided in the protocols of these trials. The purpose of this guideline is to promote transparency, completeness, reproducibility of methods, and interpretation of early phase dose-finding trial protocols.

Citation

Yap C, Rekowski J, Ursino M, Solovyeva O, Patel D, Dimairo M et al. Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance BMJ 2023; 383 :e076386 doi:10.1136/bmj-2023-076386

Summary

This paper explains and shares how a team that included researchers, patient and parent partners, and Clinical Trials Ontario, worked together with youth and parents to develop a template to report back clinical trial results to youth and their parents. The template is included in the Participant Engagement Toolkit.

Citation

Baba A, Richards DP, Smith M. et al. Youth and family involvement in the development of a plain language trial results communication tool: CommuniKIDS. Res Involv Engagem 9, 88 (2023). https://doi.org/10.1186/s40900-023-00499-2

Summary

Reporting guidelines are important for research reproducibility and to show research rigour. The DosE-FIndiNg Extensions (DEFINE) study aimed to create a guideline for clinical trial protocols and reports for studies reporting on early dose finding clinical trials (these are phase I, I/II, or dose-escalation trials) since there was not one yet.

Citation

Solovyeva, O., Dimairo, M., Weir, C.J. et al. Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study. BMC Med 21, 246 (2023). https://doi.org/10.1186/s12916-023-02937-0

Summary

This paper describes the research and results to develop the CONSORT and SPIRIT Extension for randomized clinical trials Revised in Extenuating Circumstances (abbreviated with the acronym CONSERVE) guidance for reporting trials and trial protocols that undergo important modifications in response to extenuating circumstances such as the COVID-19 pandemic.

Citation

Orkin AM, Gill PJ, Ghersi D, et al. Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement. JAMA. 2021;326(3):257–265. doi:10.1001/jama.2021.9941

Summary

There are not a lot of well designed and conducted clinical trials in the area of acupuncture, a complementary therapy that is used by many people. This paper was written by an international panel including patients, clinicians, researchers, acupuncture and surgery trialists, statisticians, and experts in clinical epidemiology and methodology about developing new guidance for randomized controlled trials in acupuncture. The paper addresses the most prevalent and critical concerns of current acupuncture trials and will help funding agencies, trial registers, and journal editors to evaluate the relevance, importance, and quality of submitted trial proposals and completed trials

Citation

Zhang Y, Jiao R, Witt C M, Lao L, Liu J, Thabane L, Cummings M, Richards, DP et al. How to design high quality acupuncture trials—a consensus informed by evidence. BMJ 2022; 376:e067476 doi:10.1136/bmj-2021-067476

Summary

This paper describes how decision aids for patient partners and researchers to engage with each other on research teams were revised based on input from the research community. Guided by the World Health Organization and IDEAS (Integrate, Design, Assess and Share) frameworks for design thinking (e.g., ideating creative strategies), dissemination (e.g., sharing locally and widely) and scalability, our research team engaged 132 people in six webinars, had 321 total page views of the decision aids and conducted 16 interviews to determine revisions to the design of the decision aids.

Citation

Parry M, Richards DP, Wells D, Najam A, Hemani S, Marlin S on behalf of the Patient-Oriented Research Decision Aids Team. Building Capacity for Patient-Oriented Research: Utilizing Decision Aids to Translate Evidence into Practice, Policy and Outcomes. Healthcare Quarterly 24(Special Issue) April 2022 : 37-43. doi:10.12927/hcq.2022.26776

Summary

This paper describes the protocol or planned approach for a research project that is not yet completed. The goal of the project will be to build capacity to improve sex/gender knowledge and strengthen patient engagement in clinical trials. The project’s goal is to refine, translate and evaluate two web-based open-access patient and investigator decision aids aimed to improve patient engagement partnerships in clinical trials.

Citation

Parry M, Ceroni T, Wells D, Richards DP, Toupin-April K, Ansari H, Bjørnnes AK, Burnside H, Cavallo S, Day A, Ellis A, Feldman D, Gilron I, Najam A, Zulfiqar Z, Marlin S. (2022). Patient Engagement Partnerships in Clinical Trials (PEP-CT): Protocol for the Systematic Development and Testing of Patient Partner and Investigator Decision Aids. BMJ Open, 12, e00267. https://bmjopen.bmj.com/content/12/2/e060267.

Summary

This paper describes the work of a research team that included patient partners to develop a tool to improve sex/gender knowledge and help patients and investigators work together as partners in clinical trials. Each decision aid has five parts: (1) Introduction (get the facts); (2) My Priorities (patient partner and investigator priorities); (3) Learn More (information on sex/gender and other resources to help patients and investigators work together); (4) My Readiness (comparing priorities with benefits and risks); and (5) My Decision (decision and next steps). These decision aids are the first to provide knowledge and support beyond the standard decision aids used for health decisions. Next steps include getting more feedback and using the decision aids in a laboratory and then in a real-life setting and to see how they can be improved.

Citation

Parry M, Bjornnes AK, Toupin-April K, Najam A, Wells D, Sivakumar A, Richards DP, Ceroni T, Park M, Ellis AK, Gilron I, Marlin S. Patient Engagement Partnerships in Clinical Trials: Development of Patient Partner and Investigator Decision Aids. Patient (2020). https://doi.org/10.1007/s40271-020-00481-0

Summary

This paper shares the research projects and results to identify factors important to participating in Huntington’s disease research. These included both enablers and barriers to participation based on a survey of the members of the Huntington’s community. It also provides examples of how such an approach can make specific suggestions about how to design targeted recruitment strategies for clinical research. This work is the result of a collaboration of researchers at the Ottawa Hospital Research Institute, individuals representing Clinical Trials Ontario, and the Huntington Society of Canada.

Citation

Carroll K, Hudek N, Bénard A, Presseau J, Richards DP, Marlin S, Fergusson DA, Graham ID, Mestre TA, Brehaut JC. Supporting Trial Participation in People with the Huntington’s Gene: A Patient-Centered, Theory-Guided Survey of Barriers and Enablers. J Huntingtons Dis. 2022;11(4):421-434. doi: 10.3233/JHD-220541. PMID: 36155526.

Summary

This paper describes the results of a survey of subscribers to the Canadian Breast Cancer Network (CBCN) in order to identify a comprehensive list of theory-informed barriers and enablers relevant to participation in a hypothetical breast cancer trial. The research shows that a comprehensive, theory-guided survey of barriers and enablers to participating in breast cancer clinical trials is possible, can lead to detailed knowledge about the issues related to participating in specific trials, and most importantly, can lead to insights about evidence-based ways to better support patient participation in clinical trials.

Citation

Brehaut JC, Carroll K, Gordon J, Presseau J, Richards DP, Fergusson DA, Graham ID, Marlin S. Results from a Theory-Guided Survey to Support Breast Cancer Trial Participation: Barriers, Enablers, and What to Do about them. Curr. Oncol. 2021, 28 (3), 2014-28. https://doi.org/10.3390/curroncol28030187

Summary

Despite clear evidence showing that many clinical trials fail or are delayed because of poor patient recruitment, there is surprisingly little evidence-based guidance for trialists who wish to optimize their recruitment strategies. This paper describes an adaptable, behavioral theory-driven approach for designing pretrial surveys of the barriers and drivers relevant to trial participation. This patient-focused and theory-guided approach was able to identify more of a range of barriers to and drivers of trial participation than existing tools. This approach allows more specific recruitment strategies to be developed once barriers are known, potentially optimizing participation for a given trial and helping build a basis of evidence of barriers/drivers and strategies for addressing them.

Citation

Brehaut, JC, Carroll K, Presseau J, Richards DP, Gordon J, Benard A, Hudek N, Graham IA, Fergusson DA, Marlin S. A patient-focused, theory-guided approach to survey design identified barriers to and drivers of clinical trial participation. J Clin Epidemiol. 2020 Dec 15;132:106-115. doi: 10.1016/j.jclinepi.2020.12.013

Summary

Colorectal Cancer Canada led developing a Canadian Patient Group Pathway to Accessing Cancer Clinical Trials (“Pathway”) – this paper details part of that work. In June 2017, a meeting of community members reached consensus on the potential roles of patient groups in the cancer clinical trials process, barriers to accessing cancer clinical trials, best practice models for patient-group integration, and a process for developing the Pathway. Developing and implementing a Canadian Pathway that incorporates the concepts of multi-stakeholder collaboration and the inclusion of patient groups as equal partners is expected to generate significant benefits for all stakeholders.

Citation

Batist G, Michaud S, Richards DP, Servidio-Italiano F, Stein BD. Developing a Model of a Patient-Group Pathway to Accessing Cancer Clinical Trials in Canada.  Current Oncology, [S.l.], v. 25, n. 6, Dec. 2018. https://doi.org/10.3747/co.25.4213

Summary

This paper details survey results of individuals in Ontario and BC about participating in clinical trials since little work has been done in Canada about these perceptions. Little is known about the Canadian public’s perspective regarding clinical trials. The research team found that while Canadians’ views about clinical trials are generally positive, they are somewhat muted and a significant minority feels poorly or not at all informed. They are less willing to participate in clinical research than Americans and are roughly equivalent to Europeans. While clinicians are the top choice for learning about clinical trials, they have little or no training and little time for this role. The team suggests that as we move toward integrating clinical trials into the practice setting, these issues of time, training, and resources must be addressed.

Citation

Willison, DJ, Richards, DP, Orth, A, Harris, H, Marlin, S. Survey of Awareness and Perceptions of Canadians on the Benefits and Risks of Clinical Trials. Therapeutic Innovation & Regulatory Science. October 2018. doi.org/10.1177/2168479018805433