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 firstname.lastname@example.org.
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 email@example.com 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 firstname.lastname@example.org.
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
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