Developing a Model of a Patient-Group Pathway to Accessing Cancer Clinical Trials in Canada

Abstract

Background Colorectal Cancer Canada, in partnership with a Scientific Advisory Committee, is developing a Canadian Patient Group Pathway to Accessing Cancer Clinical Trials (“Pathway”). A central element of the Pathway is presented here—namely, a set of recommendations and tools aimed at each stakeholder group.Methods A summary of the peer-reviewed and grey literature informed discussions at a meeting, held in June 2017, in which a cross-section of stakeholders 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. Canadian recommendations and tools were subsequently developed by a small working group and reviewed by the Scientific Advisory Committee.Results The major output of the consensus conference was agreement that the Clinical Trials Transformation Initiative (ctti) model, successfully applied in the United States, could be adapted to create a Canadian Pathway. Two main differences between the Canadian and American cancer clinical research environments were highlighted: the effects of global decision-making and systems of regulatory and funding approvals. The working group modified the ctti model to incorporate those aspects and to reflect Canadian stakeholder organizations and how they currently interact with patient groups.Conclusions Developing and implementing a Canadian Pathway that incorporates the concepts of multistakeholder collaboration and the inclusion of patient groups as equal partners is expected to generate significant benefits for all stakeholders. The next steps to bring forward a proposed Pathway will involve engaging the broader cancer research community. Clinical trial sponsors will be encouraged to adopt a Charter recognizing the importance of including patient groups, and to support the training of patient groups through an independent body to ensure quality research partners. Integration of patient groups into the process of developing “real world” evidence will be advanced by a further consensus meeting being organized by Colorectal Cancer Canada for 6–7 November 2018.

Patient and Patient Group Engagement in Cancer Clinical Trials: A Stakeholder Charter

“…detail in Batist et al [44] (Figure 1). The C-CTTI takes into account specificities of the Canadian CT environment related to the effects of global decision-making and systems of regulatory and funding approvals.…”

“…Aligned with the Charter tenets and commitments, recommendations from the CTTI/C-CTTI and other initiatives aiming at improving research co-design were to—build trust and report between researchers and co-design participants, use clear and consistent terminology, provide training if necessary, invest in co-design notably by allocating sufficient time and resources, empower and nurture participants to promote engagement, communicate and update all parties regularly, and report findings regardless of outcomes, to name a few [ 1 , 4 , 5 , 11 , 13 , 17 , 18 , 19 , 28 , 35 , 44 ].…”

“…Following an endorsement of the C-CTTI model [ 44 ] in June 2017 as a model to guide patient integration into all phases of cancer research and development in Canada, the participants of the 2018 Patient Group Pathway Model to Accessing Cancer Clinical Trials and Real-World Evidence Conference mandated CCC and the WG ( Table S1 ) to develop a charter document.…”

“…Initiated by Colorectal Cancer Canada (CCC) [ 43 ] following a consensus meeting in June 2017 on Patient Group Pathway Model to Accessing Cancer CTs, an expert working group (WG) developed a Canadianized version of the CTTI model (C-CTTI), presented in detail in Batist et al [ 44 ] ( Figure 1 ). The C-CTTI takes into account specificities of the Canadian CT environment related to the effects of global decision-making and systems of regulatory and funding approvals.…”