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.
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.
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.
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.
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.
A search tool created with and by patient partners to help people look for a clinical trial.
A glossary of commonly used terms in clinical trials.
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:
To download the Educational Materials Package, please provide your contact information.
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.
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.
The updated CONSORT (Consolidated Standards of Reporting Trials) explanation and elaboration paper describes the rationale and scientific background for each CONSORT 2025 checklist item and provides examples of good reporting. The paper aims to help users with using, understanding, and disseminating CONSORT 2025. The paper also provides guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete and transparent.
Hopewell S, Chan A, Collins G S, Hróbjartsson A, Moher D, Schulz K F et al. CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials BMJ 2025; 389:e081124 doi:10.1136/bmj-2024-081124
Well-designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. Readers need complete and transparent information on the trial’s methods and findings to interpret a randomised trial accurately.
This paper is about the CONSORT (Consolidated Standards of Reporting Trials) 2025 statement, including how it was developed and updated. The statement provides updated guidance for reporting the results of randomised trials that reflects methodological advancements and feedback from end users since its last update in 2010. The CONSORT 2025 statement consists of a 30-item checklist of essential items, a diagram for documenting the flow of participants through the trial, and an expanded checklist that details the critical elements of each checklist item. The updated checklist includes new items on data sharing; how patients and the public were involved in the design, conduct, and reporting of the trial; how harms were assessed; how missing data were handled; and details of how the intervention and comparator were administered. Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.
This paper explains how CONSORT 2025 was developed and how it has been updated. The CONSORT 2025 checklist can be found on this website.
Hopewell S, Chan A, Collins G S, Hróbjartsson A, Moher D, Schulz K F et al. CONSORT 2025 statement: updated guideline for reporting randomised trials BMJ 2025; 389 :e081123 doi:10.1136/bmj-2024-081123
This SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2025 explanation and elaboration paper describes the rationale and scientific background for each reporting item included in the SPIRIT 2025 statement and provides examples of good protocol reporting. The paper aims to provide potential users with an understanding of each checklist item and more detailed guidance for reporting. The document is primarily intended to be used in conjunction with the SPIRIT 2025 statement.
Hróbjartsson A, Boutron I, Hopewell S, Moher D, Schulz K F, Collins G S et al. SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials BMJ 2025; 389 :e081660 doi:10.1136/bmj-2024-081660
A complete, transparent, and accessible trial protocol is critical for the planning, conduct, reporting, and external review of randomised trials. This paper is about the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2025 statement, including how it was developed and updated. The statement provides guidance on items to address in trial protocols, reflecting methodological advances and feedback from users.
The SPIRIT 2025 statement consists of a checklist of 34 minimum items; a diagram illustrating the schedule of enrolment, interventions, and assessments; and an expanded checklist that details the critical elements of each checklist item. The updated SPIRIT checklist includes items related to research transparency, accessibility, and reproducibility (collectively referred to as open science) and patient and public involvement in research. Research teams, sponsors, editors, funders, and research ethics committees/institutional review boards should use and endorse SPIRIT 2025 to promote transparent protocol content.
This paper explains how SPIRIT 2025 was developed and how it has been updated. The SPIRIT 2025 checklist can be found on this website.
Chan A, Boutron I, Hopewell S, Moher D, Schulz K F, Collins G S et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials BMJ 2025; 389:e081477 doi:10.1136/bmj-2024-081477
This paper explains research Clinical Trials Ontario did from start to finish with patient, caregiver, and family partners to under what patients and the public in Canada think about decentralized and hybrid clinical trials. Our online survey (English and French) found that people would like to participate in trials that decentralize or hybridize some aspects. These types of trials are perceived to provide benefits to participants and ways to increase equity and accessibility for participants.
Richards, D.P., Queenan, J., Aasen-Johnston, L. et al. Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: “It’s About Time we Bring Trials to People”. Ther Innov Regul Sci (2024). https://doi.org/10.1007/s43441-024-00665-y
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.
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
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.
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
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.
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
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
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.
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
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
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
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.
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.
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
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.
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.
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
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.
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
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
The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement and its extensions offer evidence-based guidelines for the essential content of a clinical trial protocol. The recently published SPIRIT-Dose Finding Extension (DEFINE) focuses on essential content of a clinical trial protocol for early phase dose-finding trials. SPIRIT-DEFINE builds on SPIRIT with 17 new items and 15 modified items. This SPIRIT-DEFINE explanation and elaboration paper offers detailed explanations and real-world examples. It intends to help the trial community to develop more comprehensive, transparent, and high-quality early phase dose-finding trial protocols, leading to better implementation, fewer amendments, and improved appraisal for better patient care.
Ursino M, Villacampa G, Rekowski J, Dimairo M, Solovyeva O, Ashby D, et al. SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols. eClinicalMedicine. 2025;79. DOI: 10.1016/j.eclinm.2024.102988
The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement and its extensions offer evidence-based guidelines for the essential content of a clinical trial protocol. The recently published SPIRIT-Dose Finding Extension (DEFINE) focuses on essential content of a clinical trial protocol for early phase dose-finding trials. SPIRIT-DEFINE builds on SPIRIT with 17 new items and 15 modified items. This SPIRIT-DEFINE explanation and elaboration paper offers detailed explanations and real-world examples. It intends to help the trial community to develop more comprehensive, transparent, and high-quality early phase dose-finding trial protocols, leading to better implementation, fewer amendments, and improved appraisal for better patient care.
The CONSORT (Consolidated Standards of Reporting Trials) Statement and its extensions offer evidence-based guidelines for the essential content of clinical trial reports. The CONSORT-Dose Finding Extension (DEFINE) focuses on the reporting of early phase dose-finding trials. CONSORT-DEFINE builds on CONSORT with 21 new items and 19 modified items. This CONSORT-DEFINE explanation and elaboration paper offers detailed explanations and real-world examples. The provided examples are a resource for the trial community in developing their reports on early phase dose-finding trial results, aiming to greatly enhance both comprehensiveness and transparency, and thereby improve the overall quality of evidence available.
